A Phase II study of Rituximab ( Rituxan ) for relapsing-remitting multiple sclerosis ( RRMS ) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to placebo.
Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. Serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis. The overall rates of infection were comparable among the two treatment groups with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections and sinusitis in the Rituxan-treated patients. There were more first infusion-related reactions with Rituxan, the majority of which were mild to moderate and were generally reversible with medical intervention.
This Phase II randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with relapsing-remitting multiple sclerosis.
A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo.
Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.
Multiple sclerosis is the leading cause of neurological disability in young adults. Neurological disability typically accumulates over time and includes muscle weakness and spasticity, balance and coordination problems, as well as memory impairment and depression. Other symptoms include numbness, pain, slurred speech and blurred vision. Many patients experience fatigue and problems with bladder, bowel or sexual function.
Relapsing-remitting multiple sclerosis is the most common form of multiple sclerosis and accounts for approximately 65 percent of all MS cases. RRMS is characterized by acute exacerbations with full or partial recovery between attacks. The disease does not progress between attacks.
The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of eight years.
In general, the adverse events observed in patients with rheumatoid arthritis, an autoimmune disease, were similar in type to those seen in patients with non-Hodgkin's lymphoma ( NHL ).
The most common adverse events observed in patients treated with Rituxan for rheumatoid arthritis in clinical trials were infusion reactions and infections.
No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events or risk of opportunistic infections ( including tuberculosis ) in Rituxan-treated patients over 24 weeks of treatment. Although 5 percent of Rituxan-treated patients developed human anti-chimeric antibodies ( HACA ), this was not associated with loss of clinical response or additional safety observations.
The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema, hypotension and hypoxia. These symptoms vary in severity and generally are reversible with medical intervention.
Severe infusion reactions have been reported in patients treated with Rituxan, some with fatal outcomes in patients with NHL.
These severe reactions typically occur during the first infusion. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. Patients who develop clinically significant infusion reactions should have their Rituxan infusion discontinued and receive medical treatment.
Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of tumor lysis syndrome following treatment with Rituxan.
Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Patients experiencing a severe mucocutaneous reaction should not receive any further infusions and seek prompt medical evaluation. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell ( DLBCL ), CD20-positive, non-Hodgkin's lymphoma.
Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include Hepatitis B reactivation with fulminant hepatitis, other viral infections, hypersensitivity reactions, and cardiac arrhythmias.
Source: Genentech, 2006
XagenaMedicine2006
Saturday, September 30, 2006
Friday, September 29, 2006
AVONEX(R), the #1 Prescribed Multiple Sclerosis (MS) Therapy Worldwide: New MRI Data Presented
Sep 29 2006, 9:30 AM EST
BIOWIRE
Initial findings presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain showed that treatment with AVONEX (Interferon beta-1a) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24% (p less than 0.05) in patients with RRMS compared to baseline. Black holes are indicative of irreversible axonal damage and correlate strongly with development of long-term disability in patients with MS. Furthermore, AVONEX showed a statistically significant improvement in measures of brain atrophy (9.7% (p less than 0.0001) decrease in lateral ventricular volume in patients with RRMS compared to baseline).
The objective of this study was to evaluate the effect of AVONEX on global and focal disease as measured by multiple non-conventional and conventional MRI indices in a large sample of MS patients with either relapsing-remitting (RR) or secondary-progressive MS over 1 year. This study was an open label, single-blind, post-marketing, MRI observational study. 147 patients (131 with RRMS) were included with a mean pre-study disease duration of 11.1 years and followed for an average of 13.7 months. Patients received clinical and MRI examination at baseline and at the end of follow-up.
"This study represents one of the largest non-conventional MRI studies ever performed in patients with MS," said Dr. Robert Zivadinov, Associate Professor of Neurology and Director of the Buffalo Neuroimaging and Analysis Center, part of the Jacobs Neurological Institute, SUNY Buffalo, NY. He emphasized, "that the positive effect of AVONEX was particularly evident in patients with RRMS." This cohort represents a well-defined group of patients being on AVONEX monotherapy for a mean of 4.0 years before study entry. This study was funded by a grant from Biogen Idec.
About AVONEX
AVONEX (Interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been established.
AVONEX is the most prescribed treatment for relapsing forms of multiple sclerosis worldwide, with more than 130,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for MS patients who have their first clinical MS attack and have a brain MRI scan that suggests MS; this use was approved in Europe in 2002 and in the U.S. in 2003.
The most common side effects associated with AVONEX treatment are flu-like symptoms including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used in caution with patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding AVONEX that are subject to a number of risks and uncertainties. These statements are based on the companies' current beliefs and expectation. No forward-looking statement can be guaranteed. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include: the risk that unexpected concerns may arise from additional data or analysis or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec Inc. filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
BIOWIRE
Initial findings presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain showed that treatment with AVONEX (Interferon beta-1a) promoted a statistically significant recovery of T1-black hole lesion volume by almost 24% (p less than 0.05) in patients with RRMS compared to baseline. Black holes are indicative of irreversible axonal damage and correlate strongly with development of long-term disability in patients with MS. Furthermore, AVONEX showed a statistically significant improvement in measures of brain atrophy (9.7% (p less than 0.0001) decrease in lateral ventricular volume in patients with RRMS compared to baseline).
The objective of this study was to evaluate the effect of AVONEX on global and focal disease as measured by multiple non-conventional and conventional MRI indices in a large sample of MS patients with either relapsing-remitting (RR) or secondary-progressive MS over 1 year. This study was an open label, single-blind, post-marketing, MRI observational study. 147 patients (131 with RRMS) were included with a mean pre-study disease duration of 11.1 years and followed for an average of 13.7 months. Patients received clinical and MRI examination at baseline and at the end of follow-up.
"This study represents one of the largest non-conventional MRI studies ever performed in patients with MS," said Dr. Robert Zivadinov, Associate Professor of Neurology and Director of the Buffalo Neuroimaging and Analysis Center, part of the Jacobs Neurological Institute, SUNY Buffalo, NY. He emphasized, "that the positive effect of AVONEX was particularly evident in patients with RRMS." This cohort represents a well-defined group of patients being on AVONEX monotherapy for a mean of 4.0 years before study entry. This study was funded by a grant from Biogen Idec.
About AVONEX
AVONEX (Interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been established.
AVONEX is the most prescribed treatment for relapsing forms of multiple sclerosis worldwide, with more than 130,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for MS patients who have their first clinical MS attack and have a brain MRI scan that suggests MS; this use was approved in Europe in 2002 and in the U.S. in 2003.
The most common side effects associated with AVONEX treatment are flu-like symptoms including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used in caution with patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding AVONEX that are subject to a number of risks and uncertainties. These statements are based on the companies' current beliefs and expectation. No forward-looking statement can be guaranteed. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include: the risk that unexpected concerns may arise from additional data or analysis or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec Inc. filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
New Data Presented at ECTRIMS Congress Show TYSABRI® Has Sustained Effect on Relapse Rate in Multiple Sclerosis Patients Treated for up to Three Years
September 29, 2006 09:00 AM Eastern Time
BIOWIRE2K
ZUG, Switzerland and DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today new data that show TYSABRI® (natalizumab) has a sustained effect on relapse rate in multiple sclerosis (MS) patients treated for up to three years. These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, were part of long-term follow-up of TYSABRI clinical trial patients.
Patients who participated in the Phase III TYSABRI program were eligible to enroll in an open-label extension study that evaluated the therapy’s long-term effects. Approximately 1,900 patients and over 200 sites worldwide participated in the extension study. Approximately 250 of these patients remained on TYSABRI monotherapy for nearly three years. The annualized relapse rate for these patients over the three-year period was 0.23, translating into an average of one relapse every 4.3 years. This was consistent with the 0.23 annualized relapse rate seen in the two-year AFFIRM study, which represented a 68% relative reduction when compared to the two-year placebo annualized relapse rate of 0.73, as published in the New England Journal of Medicine.
“Data from this long-term follow-up study show that TYSABRI has a sustained and compelling effect on relapse rates beyond two years of treatment. The efficacy benefit of TYSABRI when considered with the management of its known risks, offers an important therapeutic option for many patients living with the debilitating effects of MS,” said Paul O’Connor, MD, St. Michael’s Hospital, Toronto, Ontario, Canada, lead investigator of the extension study.
About TYSABRI
In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.
In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS. According to product labeling in the EU, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
Serious adverse events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Herpes infections were slightly more common in patients treated with TYSABRI. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
Analyst Worries About Tysabri
By Althea Chang
TheStreet.com Staff Reporter
9/26/2006 11:40 AM EDT
Tysabri, the multiple sclerosis treatment from Elan (ELN - commentary - Cramer's Take) and Biogen Idec (BIIB - commentary - Cramer's Take), appears to be getting hit by the strict safety rules that accompanied the drug's reapproval by regulators, according to one analyst.
Deborah Knobelman of the research firm Piper Jaffray slashed her estimate for worldwide Tysabri sales to $21 million for this year, down from her previous $123 million expectation. According to her feedback from doctors, physicians' adoption rates of the drug were slower than she had anticipated in the U.S. because of safety concerns, reimbursement procedures and patient-monitoring requirements.
Tysabri was recleared by the Food and Drug Administration earlier this year after being taken off the market for fear it could be linked to a potentially fatal brain illness. Before the drug could again go on sale, its makers had to agree to meet a number of criteria dealing with safety monitoring for side effects.
"The current, and in our view, overvalued, [Elan] stock price is not reflective of our new 2006 Tysabri estimates," Knobelman wrote in a research report. "Even if Tysabri revenues reach $1 billion (our peak sales assumption), the stock's current valuation reflects almost double Tysabri's peak potential. We believe [Elan's] Q3 report will reflect our lowered estimates, which might close the stock price's valuation disconnect."
Knobelman maintained an underperform rating on Elan's shares, with a price target of $10. The stock was trading down 14 cents, or 0.9%, at $15.73 Tuesday. Biogen Idec's shares fell 7 cents, or 0.2%, to $44.64.
TheStreet.com Staff Reporter
9/26/2006 11:40 AM EDT
Tysabri, the multiple sclerosis treatment from Elan (ELN - commentary - Cramer's Take) and Biogen Idec (BIIB - commentary - Cramer's Take), appears to be getting hit by the strict safety rules that accompanied the drug's reapproval by regulators, according to one analyst.
Deborah Knobelman of the research firm Piper Jaffray slashed her estimate for worldwide Tysabri sales to $21 million for this year, down from her previous $123 million expectation. According to her feedback from doctors, physicians' adoption rates of the drug were slower than she had anticipated in the U.S. because of safety concerns, reimbursement procedures and patient-monitoring requirements.
Tysabri was recleared by the Food and Drug Administration earlier this year after being taken off the market for fear it could be linked to a potentially fatal brain illness. Before the drug could again go on sale, its makers had to agree to meet a number of criteria dealing with safety monitoring for side effects.
"The current, and in our view, overvalued, [Elan] stock price is not reflective of our new 2006 Tysabri estimates," Knobelman wrote in a research report. "Even if Tysabri revenues reach $1 billion (our peak sales assumption), the stock's current valuation reflects almost double Tysabri's peak potential. We believe [Elan's] Q3 report will reflect our lowered estimates, which might close the stock price's valuation disconnect."
Knobelman maintained an underperform rating on Elan's shares, with a price target of $10. The stock was trading down 14 cents, or 0.9%, at $15.73 Tuesday. Biogen Idec's shares fell 7 cents, or 0.2%, to $44.64.
Thursday, September 28, 2006
MS care 'still not up to scratch'
The NHS has barely begun to implement recommendations made over two years ago to improve care of people with multiple sclerosis, a report by doctors says.
The NHS treatment watchdog had called for faster diagnosis, more specialist services and better tailored care.
But the report commissioned by the MS Trust and the Royal College of Physicians found services were of "low quality and inadequate quantity'.
The government said it expected the NHS to adhere to the guidelines on MS care.
"I have been made to feel that because my MS is incurable then I am not worth taking the time with." - MS patient
MS, which affects about 85,000 people in the UK, is a disease of the central nervous system. It causes the break down of the myelin sheath, a fatty protein, which coats nerve fibres.
No firm targets
The latest study examined how strategic health authorities, primary care trusts and hospitals were dealing with MS.
It found disappointing levels of progress - and a lack of data collection which made assessing reform difficult.
"I was assessed, agreement reached that I needed a shower facility. I was told I was on a three to four year waiting list. I have fallen several times climbing into the bath. When I questioned this lengthy wait I was told there were people more needy than me. I asked who, and was told 'cancer patients'." - MS patient
This, the authors blamed on a failure by the National Institute for Health and Clinical Excellence to set concrete targets.
MS patients said they were dissatisfied with the quality of their care.
Professor Derick Wade, an expert in neurological rehabilitation at Oxford University, worked on the report.
He said: "It cannot be left to individual clinicians to make piecemeal progress. Without strong support from commissioning organisations and hospital trusts, significant progress will not occur."
Professor Dame Carol Black, president of the Royal College of Physicians, said the findings suggested MS was a low priority in the NHS.
"This audit is disappointing for patients, who looked for improvements following the issue of NICE guidelines.
"It reminds us that merely setting service standards, without adequate arrangements for quality assurance, falls short of what patients are right to expect."
Christine Jones, chief executive of the MS Trust said the disease was ignored because it was difficult to treat.
"There are some pockets of excellent practice but services for people with MS are, in the main, in a very sorry state and we can ill-afford to waste two years in putting the situation right."
'Joined-up approach'
Dr Gillian Leng, of NICE, said: "At the time of the guideline's publication in November 2003 it was widely seen as representing a catalyst for change that would inform a more joined-up approach to service delivery in an area of healthcare that had not, until then, benefited from the application of a consistent and coherent national approach.
"But, as this report indicates, the NHS can do more to implement the guideline's key recommendations in order to ensure that people with MS are receiving the best possible levels of care."
A Department of Health spokesman said it expected the NHS to take "full account" of the NICE guidelines.
"They are now included in the national standards used to measure local NHS performance and are taken in to consideration by the Healthcare Commission when they produce their annual reports on NHS bodies."
Story from BBC NEWS:
Published: 2006/07/19 00:17:33 GMT
© BBC MMVI
Xanthus' Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model
Thursday September 28, 9:30 am ET
- Results Presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis -
CAMBRIDGE, Mass., Sept. 28 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in a poster session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.
Dr. Karlik used a model of experimental allergic encephalomyelitis (EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent.
"We believe that Symadex has a distinct activity profile in the field of MS therapies. Interestingly, we found that Symadex has no effect on the acute, T-cell mediated portion of the disease process which is the target of most proposed new therapies for MS," stated Alfred Ajami, PhD, Chief Scientific Officer at Xanthus.
About Symadex(TM)
Symadex (formerly C-1311) is the lead compound in clinical development from a new series of agents, the imidazoacridinones, which have shown in vitro to be potent and selective FLT3 receptor tyrosine kinase inhibitors. Symadex is currently in Phase 2 clinical trials in oncology indications. Xanthus is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis, where early preclinical data has shown encouraging signs of activity.
About Xanthus Pharmaceuticals, Inc.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.
Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at http://www.xanthus.com.
This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patent and patent applications owned or licensed by Xanthus will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. -- kwatson@macbiocom.com or (508) 647-0209
Lisa Terry, Xanthus Pharmaceuticals, Inc. -- lisa.terry@xanthus.com or (617) 225-0522, x 105
Source: Xanthus Pharmaceuticals, Inc.
Xanthus' Symadex shows Remyelination in Multiple Sclerosis Animal Model
02/14/2006 - Xanthus Life Sciences, Inc., announced that data from a study conducted with a Multiple Sclerosis (MS) animal model demonstrated that Symadex(TM) permitted remyelination by prevention of inflammatory cell infiltration. Stephen J. Karlik, Ph.D., Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario presented the research findings in Vancouver.
Symadex was found to produce remyelination in the study even after 40 days of inflammatory insult by preventing the infiltration of autoreactive cells into the central nervous system. Treatment proved to be effective in both the acute and chronic presentations of disease.
"The early results from this study showed that the animals in the study, which were paralyzed due to neurological impairment, were able to recover and regain their mobility after treatment with Symadex," commented Dr. Karlik.
"Symadex is now in Phase 2 trials in oncology and the positive results of this animal model study show the candidate's potential for treating MS and provide the support needed to advance Symadex towards human trials for MS," said Michael A. Boss, PhD. Chief Business Officer at Xanthus. Symadex (formerly C-1311) is a next-generation investigational drug that has shown a potentially novel, targeted mechanism of action in studies of cancer and autoimmune disease. Symadex was developed to deliver efficacy comparable to the anthracenediones (e.g., Novantrone(R) (mitoxantrone)), but with a molecular scaffold intended to reduce the cardio- and hemato-toxicities known to be associated with these active drugs. Additionally, in previous preclinical studies, Symadex has shown early evidence of both oral activity and efficacy in various models of acquired drug resistance and autoimmune disease. The Company is conducting Phase 2 clinical trials with Symadex in several tumor indications and is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as Multiple Sclerosis.
- Results Presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis -
CAMBRIDGE, Mass., Sept. 28 /PRNewswire/ -- Xanthus Pharmaceuticals, Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in a poster session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.
Dr. Karlik used a model of experimental allergic encephalomyelitis (EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent.
"We believe that Symadex has a distinct activity profile in the field of MS therapies. Interestingly, we found that Symadex has no effect on the acute, T-cell mediated portion of the disease process which is the target of most proposed new therapies for MS," stated Alfred Ajami, PhD, Chief Scientific Officer at Xanthus.
About Symadex(TM)
Symadex (formerly C-1311) is the lead compound in clinical development from a new series of agents, the imidazoacridinones, which have shown in vitro to be potent and selective FLT3 receptor tyrosine kinase inhibitors. Symadex is currently in Phase 2 clinical trials in oncology indications. Xanthus is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis, where early preclinical data has shown encouraging signs of activity.
About Xanthus Pharmaceuticals, Inc.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule oncology candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.
Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at http://www.xanthus.com.
This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials or warrant additional trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patent and patent applications owned or licensed by Xanthus will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. -- kwatson@macbiocom.com or (508) 647-0209
Lisa Terry, Xanthus Pharmaceuticals, Inc. -- lisa.terry@xanthus.com or (617) 225-0522, x 105
Source: Xanthus Pharmaceuticals, Inc.
Xanthus' Symadex shows Remyelination in Multiple Sclerosis Animal Model
02/14/2006 - Xanthus Life Sciences, Inc., announced that data from a study conducted with a Multiple Sclerosis (MS) animal model demonstrated that Symadex(TM) permitted remyelination by prevention of inflammatory cell infiltration. Stephen J. Karlik, Ph.D., Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario presented the research findings in Vancouver.
Symadex was found to produce remyelination in the study even after 40 days of inflammatory insult by preventing the infiltration of autoreactive cells into the central nervous system. Treatment proved to be effective in both the acute and chronic presentations of disease.
"The early results from this study showed that the animals in the study, which were paralyzed due to neurological impairment, were able to recover and regain their mobility after treatment with Symadex," commented Dr. Karlik.
"Symadex is now in Phase 2 trials in oncology and the positive results of this animal model study show the candidate's potential for treating MS and provide the support needed to advance Symadex towards human trials for MS," said Michael A. Boss, PhD. Chief Business Officer at Xanthus. Symadex (formerly C-1311) is a next-generation investigational drug that has shown a potentially novel, targeted mechanism of action in studies of cancer and autoimmune disease. Symadex was developed to deliver efficacy comparable to the anthracenediones (e.g., Novantrone(R) (mitoxantrone)), but with a molecular scaffold intended to reduce the cardio- and hemato-toxicities known to be associated with these active drugs. Additionally, in previous preclinical studies, Symadex has shown early evidence of both oral activity and efficacy in various models of acquired drug resistance and autoimmune disease. The Company is conducting Phase 2 clinical trials with Symadex in several tumor indications and is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as Multiple Sclerosis.
Wednesday, September 27, 2006
A Statin Improves Performance of Multiple Sclerosis Drug
While the text in the link to the study in the Journal of Clinical Investigation is - well scientific - it may be worth a read. But the substance of it is below:
Dual therapy reduced inflammation, eliminated paralysis in mice, study finds
By Ed Edelson
HealthDay Reporter
THURSDAY, March 16 (HealthDay News) -- The same researchers who showed that a cholesterol-lowering statin drug might prevent development of full-blown multiple sclerosis are now reporting that statin therapy might improve the performance of existing MS drugs.
The first discovery led to a nationwide study in which people who have the initial symptoms of the autoimmune nerve-damaging disease are taking a statin in hopes of avoiding MS.
"What we have shown now is that we have data in an animal model, that when this statin is used in combination with Copaxone, it may augment the activity of Copaxone," said study co-author Dr. Scott Zamvil, associate professor of neurology at the University of California, San Francisco. "That is provocative data supporting human testing of this combination."
While the research has so far been limited to lab mice, the scientists hope the findings might one day lead to improved treatments for people with the disease. The findings appear in the March 16 online edition of the Journal of Clinical Investigation.
Combination therapy is desirable because Copaxone, like other MS drugs, is effective in only 30 percent to 35 percent of cases of the most common form of the disease, Zamvil said. In one animal study, adding high doses of atorvastatin (Lipitor) dramatically reduced central nervous system inflammation and seemed to eliminate the paralysis caused by a model disease that closely resembles MS. In contrast, there was no reversal of the disease in animals that received low doses of Lipitor or Copaxone.
In multiple sclerosis, immune cells attack a layer of insulation known as myelin that surrounds nerve fibers in the brain and spinal cord. Copaxone is one of a family of drugs that suppresses the activity of the chemicals that destroy myelin.
Lipitor also appears to act against the destructive immune system activity, but through a different mechanism, Zamvil said. "They can have an additive effect," he said, referring to the combination of Lipitor and Copaxone. "We were able to see a clinical and immunological benefit."
The results do not necessarily apply to all statin drugs, he said. "They all act on the same enzyme to reduce cholesterol but they differ in their ability to cause immune modulation," Zamvil said. Data from unpublished studies indicate that Lipitor has more immune system activity, he said.
Zamvil said he's aware that some people with MS are already taking a statin, but he advised against it at this point to combat the disease. "We don't know if it is effective or not at this stage," he said. "Even though they [statins] are relatively safe, we are speaking of higher doses."
That caution was echoed by Dr. Jeffrey Cohen, a neurologist at the Cleveland Clinic, one of 14 U.S. centers involved in a trial of statin therapy to prevent MS in people who have had a first neurological event that often leads to the disease. The trial has been going on for a year, and five people have been enrolled at the Cleveland Clinic, he said, adding that results of the trial might start to emerge in a year or two.
"There is a lot of interest in statins and they are generally well tolerated, but we are cautioning people not to rely on statins for multiple sclerosis treatment," Cohen said. "The doses are on the high side, so there is some potential for side effects and toxicity."
Inevitably, some people treated for MS at the Cleveland Clinic are taking a statin because they have high cholesterol, Cohen said. "It doesn't appear to have an adverse effect on MS, and at this point it is hard to determine whether it is helpful for MS," he said.
SOURCES: Scott Zamvil, M.D., Ph.D, associate professor of neurology, University of California, San Francisco; Jeffrey Cohen, M.D., neurologist, Cleveland Clinic; March 16, 2006, online edition, Journal of Clinical Investigation
Copyright ©2006 ScoutNews LLC All rights reserved
Dual therapy reduced inflammation, eliminated paralysis in mice, study finds
By Ed Edelson
HealthDay Reporter
THURSDAY, March 16 (HealthDay News) -- The same researchers who showed that a cholesterol-lowering statin drug might prevent development of full-blown multiple sclerosis are now reporting that statin therapy might improve the performance of existing MS drugs.
The first discovery led to a nationwide study in which people who have the initial symptoms of the autoimmune nerve-damaging disease are taking a statin in hopes of avoiding MS.
"What we have shown now is that we have data in an animal model, that when this statin is used in combination with Copaxone, it may augment the activity of Copaxone," said study co-author Dr. Scott Zamvil, associate professor of neurology at the University of California, San Francisco. "That is provocative data supporting human testing of this combination."
While the research has so far been limited to lab mice, the scientists hope the findings might one day lead to improved treatments for people with the disease. The findings appear in the March 16 online edition of the Journal of Clinical Investigation.
Combination therapy is desirable because Copaxone, like other MS drugs, is effective in only 30 percent to 35 percent of cases of the most common form of the disease, Zamvil said. In one animal study, adding high doses of atorvastatin (Lipitor) dramatically reduced central nervous system inflammation and seemed to eliminate the paralysis caused by a model disease that closely resembles MS. In contrast, there was no reversal of the disease in animals that received low doses of Lipitor or Copaxone.
In multiple sclerosis, immune cells attack a layer of insulation known as myelin that surrounds nerve fibers in the brain and spinal cord. Copaxone is one of a family of drugs that suppresses the activity of the chemicals that destroy myelin.
Lipitor also appears to act against the destructive immune system activity, but through a different mechanism, Zamvil said. "They can have an additive effect," he said, referring to the combination of Lipitor and Copaxone. "We were able to see a clinical and immunological benefit."
The results do not necessarily apply to all statin drugs, he said. "They all act on the same enzyme to reduce cholesterol but they differ in their ability to cause immune modulation," Zamvil said. Data from unpublished studies indicate that Lipitor has more immune system activity, he said.
Zamvil said he's aware that some people with MS are already taking a statin, but he advised against it at this point to combat the disease. "We don't know if it is effective or not at this stage," he said. "Even though they [statins] are relatively safe, we are speaking of higher doses."
That caution was echoed by Dr. Jeffrey Cohen, a neurologist at the Cleveland Clinic, one of 14 U.S. centers involved in a trial of statin therapy to prevent MS in people who have had a first neurological event that often leads to the disease. The trial has been going on for a year, and five people have been enrolled at the Cleveland Clinic, he said, adding that results of the trial might start to emerge in a year or two.
"There is a lot of interest in statins and they are generally well tolerated, but we are cautioning people not to rely on statins for multiple sclerosis treatment," Cohen said. "The doses are on the high side, so there is some potential for side effects and toxicity."
Inevitably, some people treated for MS at the Cleveland Clinic are taking a statin because they have high cholesterol, Cohen said. "It doesn't appear to have an adverse effect on MS, and at this point it is hard to determine whether it is helpful for MS," he said.
SOURCES: Scott Zamvil, M.D., Ph.D, associate professor of neurology, University of California, San Francisco; Jeffrey Cohen, M.D., neurologist, Cleveland Clinic; March 16, 2006, online edition, Journal of Clinical Investigation
Copyright ©2006 ScoutNews LLC All rights reserved
Zocor Treats Multiple Sclerosis
People have been asking about me use of statin drugs in multiple sclerosis. The following article is more than three years old, but contains information that I believe MSers should be aware of. Research has proceeded at a snail's pace since 2003, largely because the pharmaceutical companies have ben unwilling to put adequate amoutns of money into statin drug trials. Their big statin market is anti-cholesterol. The U.S. market for statin drugs, alone, currently exceeds $16 Billion annually and is continuing its rapid growth. About 12 million Americans are currently taking statin drugs. The potential size of the anti-cholesterol market in the U.S., alone, exceeds 23 million. In contrast, there are an estimated 400,000 MSers in the U.S.
Cholesterol Drug Reduces Size, Number of Brain Lesions
By Larry Schuster
WebMD Medical News
Reviewed By Michael Smith, MD on Wednesday, April 02, 2003
April 2, 2003 (Honolulu) -- Researchers have presented the first human findings looking at a cholesterol-lowering drug for multiple sclerosis treatment. They found that Zocor not only reduces the size but also the number of brain lesions from MS.
In multiple sclerosis, cells in the immune system destroy the protective lining -- called myelin -- of nerves in the brain and spinal cord.
Animal research touting cholesterol-lowering drugs called "statins" as a multiple sclerosis treatment hit the scene just last year, and the research has quickly moved from mice to humans. In a recent animal study, researchers found that Lipitor -- another statin -- prevented disease progression and reversed paralysis in mice with a multiple sclerosis-like disease.
In the current study, Timothy Vollmer, MD, and colleagues studied 28 people with the most common form of multiple sclerosis, called relapsing-remitting -- in which periods of relapse, when symptoms flare up, alternate with periods of remission, when symptoms fade. Vollmer, chairman of the division of neurology at the Barrow Neurological Institute in Phoenix, presented the results in Honolulu at the annual conference of the American Academy of Neurology.
The study participants -- aged 18 to 55 -- had evidence of at least one brain lesion from multiple sclerosis on an MRI brain scan. Each participant then took 80 mg of Zocor daily and underwent a series of MRI brain scans during the study. The study was supported by Merck Inc., Zocor's manufacturer.
Six months into treatment, the researchers found that the number of brain lesions was reduced by 43%. In addition, the researchers projected that Zocor would decrease the annual rate of relapses from 43% before treatment to 32% after treatment.
Zocor as a multiple sclerosis treatment was well tolerated by the patients, Vollmer says. "No patient stopped due to side effects."
When used to lower cholesterol, Zocor and other statins can occasionally raise liver enzymes -- indicating that the drug may be harming the liver. In this study, two of the patients had mildly elevated liver tests, which resolved after stopping the drug, says Vollmer.
Vollmer says he believes Zocor and other statins may work by suppressing an overactive part of the immune system.
"Anything that suppresses seems to be helpful," he says, and research on mice and rats has shown statins to be effective at suppressing inflammatory cells from entering the brain.
One possible additional benefit of the drug, Vollmer says, is that it appears that Zocor might be able to enter the brain to work directly on key target sites. If so, that raises the possibility that Zocor may be an effective multiple sclerosis treatment for slowing progression of the disease, Vollmer says.
But even though the study indicates that there may be a role for statins in multiple sclerosis treatment one way or another, exactly how they would be used still has to be worked out, Vollmer says.
He is beginning preliminary planning for a trial in the next year or so on the use of one or more statins in combination with currently approved multiple sclerosis treatments.
Vollmer envisions that there ought to be enough research completed in about four years for a consensus to emerge about statins' potential role as multiple sclerosis treatments.
Stephen Reingold, PhD, vice president of research for the National Multiple Sclerosis Society in New York, tells WebMD the advantages of the drug are that it's oral, it's well known, it's not expensive, and side effects are low.
"It's a small study," and it needs a clinical trial lasting at least a couple of years to see how well statins work for multiple sclerosis treatment.
Vollmer says that statins -- if proven to be of benefit in future studies -- could have several advantages over current multiple sclerosis treatments.
* Commonly used multiple sclerosis treatments, such as interferon, Copaxone, and Novantrone, cost $10,000 or more a year, compared with $1,000 to $2,000 a year for Zocor.
* Current multiple sclerosis treatments are by injection, compared with statins, which are taken orally.
* Four of the current multiple sclerosis treatments have what Vollmer termed nuisance side effects: pain and swelling at the site of injection, and occasionally flu-like symptoms.
* Novantrone, a chemotherapy drug, has been associated with infections, cancer, and heart and liver damage. Though it's often more effective than other multiple sclerosis treatments, its side effects limits it to 5% to 10% of people with multiple sclerosis.
SOURCES: American Academy of Neurology 55th Annual Meeting, Honolulu, March 29-April 5, 2003. Stephen Reingold, PhD, vice president of research, National Multiple Sclerosis Society.
© 2003 WebMD Inc. All rights reserved.
Cholesterol Drug Reduces Size, Number of Brain Lesions
By Larry Schuster
WebMD Medical News
Reviewed By Michael Smith, MD on Wednesday, April 02, 2003
April 2, 2003 (Honolulu) -- Researchers have presented the first human findings looking at a cholesterol-lowering drug for multiple sclerosis treatment. They found that Zocor not only reduces the size but also the number of brain lesions from MS.
In multiple sclerosis, cells in the immune system destroy the protective lining -- called myelin -- of nerves in the brain and spinal cord.
Animal research touting cholesterol-lowering drugs called "statins" as a multiple sclerosis treatment hit the scene just last year, and the research has quickly moved from mice to humans. In a recent animal study, researchers found that Lipitor -- another statin -- prevented disease progression and reversed paralysis in mice with a multiple sclerosis-like disease.
In the current study, Timothy Vollmer, MD, and colleagues studied 28 people with the most common form of multiple sclerosis, called relapsing-remitting -- in which periods of relapse, when symptoms flare up, alternate with periods of remission, when symptoms fade. Vollmer, chairman of the division of neurology at the Barrow Neurological Institute in Phoenix, presented the results in Honolulu at the annual conference of the American Academy of Neurology.
The study participants -- aged 18 to 55 -- had evidence of at least one brain lesion from multiple sclerosis on an MRI brain scan. Each participant then took 80 mg of Zocor daily and underwent a series of MRI brain scans during the study. The study was supported by Merck Inc., Zocor's manufacturer.
Six months into treatment, the researchers found that the number of brain lesions was reduced by 43%. In addition, the researchers projected that Zocor would decrease the annual rate of relapses from 43% before treatment to 32% after treatment.
Zocor as a multiple sclerosis treatment was well tolerated by the patients, Vollmer says. "No patient stopped due to side effects."
When used to lower cholesterol, Zocor and other statins can occasionally raise liver enzymes -- indicating that the drug may be harming the liver. In this study, two of the patients had mildly elevated liver tests, which resolved after stopping the drug, says Vollmer.
Vollmer says he believes Zocor and other statins may work by suppressing an overactive part of the immune system.
"Anything that suppresses seems to be helpful," he says, and research on mice and rats has shown statins to be effective at suppressing inflammatory cells from entering the brain.
One possible additional benefit of the drug, Vollmer says, is that it appears that Zocor might be able to enter the brain to work directly on key target sites. If so, that raises the possibility that Zocor may be an effective multiple sclerosis treatment for slowing progression of the disease, Vollmer says.
But even though the study indicates that there may be a role for statins in multiple sclerosis treatment one way or another, exactly how they would be used still has to be worked out, Vollmer says.
He is beginning preliminary planning for a trial in the next year or so on the use of one or more statins in combination with currently approved multiple sclerosis treatments.
Vollmer envisions that there ought to be enough research completed in about four years for a consensus to emerge about statins' potential role as multiple sclerosis treatments.
Stephen Reingold, PhD, vice president of research for the National Multiple Sclerosis Society in New York, tells WebMD the advantages of the drug are that it's oral, it's well known, it's not expensive, and side effects are low.
"It's a small study," and it needs a clinical trial lasting at least a couple of years to see how well statins work for multiple sclerosis treatment.
Vollmer says that statins -- if proven to be of benefit in future studies -- could have several advantages over current multiple sclerosis treatments.
* Commonly used multiple sclerosis treatments, such as interferon, Copaxone, and Novantrone, cost $10,000 or more a year, compared with $1,000 to $2,000 a year for Zocor.
* Current multiple sclerosis treatments are by injection, compared with statins, which are taken orally.
* Four of the current multiple sclerosis treatments have what Vollmer termed nuisance side effects: pain and swelling at the site of injection, and occasionally flu-like symptoms.
* Novantrone, a chemotherapy drug, has been associated with infections, cancer, and heart and liver damage. Though it's often more effective than other multiple sclerosis treatments, its side effects limits it to 5% to 10% of people with multiple sclerosis.
SOURCES: American Academy of Neurology 55th Annual Meeting, Honolulu, March 29-April 5, 2003. Stephen Reingold, PhD, vice president of research, National Multiple Sclerosis Society.
© 2003 WebMD Inc. All rights reserved.
MS Drugs Unsafe in Pregnancy?
Many people have queried: "Are current MS immunomodulating and other drug therapies safe during pregnancy?"
In many cases, either the pharmaceutical companies have made no statement or tested their safety during pregnancy, or "the jury may still be out." However, in some cases, the answer is a definitive "NO."
Here's a list:
IMMUNOMODULATORS
AVONEX (Interferon beta-1a) - contraindicated in pregnancy
BETASERON (Interferon beta-1b) - contraindicated in pregnancy
COPAXONE (Glatiramer Acetate) - usually safe but benefits must outweigh the risks
REBIF (Interferon beta-1a) - safety for use during pregnancy has not been established
TYSABRI (Natalizumab) - safety for use during pregnancy has not been established
IMMUNOSUPRESSANTS
NOVANTRONE (Mitoxantrone) - unsafe in pregnancy
CYTOXAN or NEOSAR (Cyclophosphamide) - unsafe in pregnancy
CORTICOSTEROIDS
SOLU-MEDROL, DEPO-MEDROL (methylprednisolone) - safety for use during pregnancy has not been established
FOR DETAILED INFORMATION AND GUIDANCE, PLEASE CONSULT YOUR PHYSICIANS.
In many cases, either the pharmaceutical companies have made no statement or tested their safety during pregnancy, or "the jury may still be out." However, in some cases, the answer is a definitive "NO."
Here's a list:
IMMUNOMODULATORS
AVONEX (Interferon beta-1a) - contraindicated in pregnancy
BETASERON (Interferon beta-1b) - contraindicated in pregnancy
COPAXONE (Glatiramer Acetate) - usually safe but benefits must outweigh the risks
REBIF (Interferon beta-1a) - safety for use during pregnancy has not been established
TYSABRI (Natalizumab) - safety for use during pregnancy has not been established
IMMUNOSUPRESSANTS
NOVANTRONE (Mitoxantrone) - unsafe in pregnancy
CYTOXAN or NEOSAR (Cyclophosphamide) - unsafe in pregnancy
CORTICOSTEROIDS
SOLU-MEDROL, DEPO-MEDROL (methylprednisolone) - safety for use during pregnancy has not been established
FOR DETAILED INFORMATION AND GUIDANCE, PLEASE CONSULT YOUR PHYSICIANS.
Tuesday, September 26, 2006
Study: Doctors not giving patients full prescription info
By LEE BOWMAN
Scripps Howard News Service
25-SEP-06
Doctors tell patients how they should take a new drug only about half the time, often don't even mention the name of the drug being prescribed and fail to discuss possible side effects two-thirds of the time, according to a new study.
Researchers at the University of California-Los Angeles evaluated how 44 physicians discussed new prescriptions in nearly 200 tape-recorded encounters at two health-care systems in Sacramento.
Doctors were rated on five essential points: the drug's name; the reason for taking it; the duration of use; the number of doses and their timing, and common side effects. The researchers found that, on average, the doctors covered about 62 percent of the information.
"This study demonstrates spotty physician counseling about new medication prescriptions, when we know that patients who have better physician communication, better explanations about how to take their medications and more medication information are more adherent," said Dr. Derjung Tarn, a family-medicine instructor and researcher at UCLA's David Geffen School of Medicine and lead author of the report. It was published Monday in the Archives of Internal Medicine.
Government surveys show that almost half of all Americans take at least one prescription drug on a regular basis, and that half of the elderly take three or more drugs regularly.
During the study, 243 new medications were prescribed to 185 patients _ most commonly, heart and blood-pressure drugs; ear, nose and throat preparations; pain relievers, and antibiotics.
The researchers studied transcripts of each session and checked off each type of communication that took place. The recordings took place with the patients' consent.
Researchers found that physicians used the specific name of the new drug just 74 percent of the time and explained the purpose of the drug 87 percent of the time. But the researchers also found the doctors discussed the number of tablets to take in just 55 percent of the encounters, and went over possible adverse effects just 35 percent of the time.
"Although physicians educated patients more about psychiatric and analgesic medications, the overall quality of communication was poor even for those medication types, and could contribute to patient misunderstandings," the researchers said in the study.
According to a report issued by the national Institute of Medicine earlier this year, at least 1.5 million Americans are sickened, injured or killed annually due to errors in prescribing, dispensing and taking medications.
Much of the focus on these errors has been on patients getting the wrong drug or a wrong dose due to mistakes made by doctors and pharmacists. But experts also point out that overdosing or underdosing by patients who don't receive or follow directions is equally dangerous.
Even if a patient doesn't leave the doctor's office with a written script in this era of increasing electronic prescribing, studies suggest that giving him or her basic information about the medication adds some assurance that the right medicine will be taken the right way.
Tarn and her colleagues said that it's unclear just how important it is that doctors tell patients about new drugs, since people do get information from pharmacists and other sources, and this study didn't look at what happened after patients left the doctor's office.
More research needs to be done to prove whether better communication by doctors about medicines actually results in proper use of the drugs and improved health outcomes, they wrote.
On the Net: http://archinte.ama-assn.org
(Contact Lee Bowman at BowmanL(at)SHNS.com. Distributed by Scripps Howard News Service, http://www.shns.com)
Scripps Howard News Service
25-SEP-06
Doctors tell patients how they should take a new drug only about half the time, often don't even mention the name of the drug being prescribed and fail to discuss possible side effects two-thirds of the time, according to a new study.
Researchers at the University of California-Los Angeles evaluated how 44 physicians discussed new prescriptions in nearly 200 tape-recorded encounters at two health-care systems in Sacramento.
Doctors were rated on five essential points: the drug's name; the reason for taking it; the duration of use; the number of doses and their timing, and common side effects. The researchers found that, on average, the doctors covered about 62 percent of the information.
"This study demonstrates spotty physician counseling about new medication prescriptions, when we know that patients who have better physician communication, better explanations about how to take their medications and more medication information are more adherent," said Dr. Derjung Tarn, a family-medicine instructor and researcher at UCLA's David Geffen School of Medicine and lead author of the report. It was published Monday in the Archives of Internal Medicine.
Government surveys show that almost half of all Americans take at least one prescription drug on a regular basis, and that half of the elderly take three or more drugs regularly.
During the study, 243 new medications were prescribed to 185 patients _ most commonly, heart and blood-pressure drugs; ear, nose and throat preparations; pain relievers, and antibiotics.
The researchers studied transcripts of each session and checked off each type of communication that took place. The recordings took place with the patients' consent.
Researchers found that physicians used the specific name of the new drug just 74 percent of the time and explained the purpose of the drug 87 percent of the time. But the researchers also found the doctors discussed the number of tablets to take in just 55 percent of the encounters, and went over possible adverse effects just 35 percent of the time.
"Although physicians educated patients more about psychiatric and analgesic medications, the overall quality of communication was poor even for those medication types, and could contribute to patient misunderstandings," the researchers said in the study.
According to a report issued by the national Institute of Medicine earlier this year, at least 1.5 million Americans are sickened, injured or killed annually due to errors in prescribing, dispensing and taking medications.
Much of the focus on these errors has been on patients getting the wrong drug or a wrong dose due to mistakes made by doctors and pharmacists. But experts also point out that overdosing or underdosing by patients who don't receive or follow directions is equally dangerous.
Even if a patient doesn't leave the doctor's office with a written script in this era of increasing electronic prescribing, studies suggest that giving him or her basic information about the medication adds some assurance that the right medicine will be taken the right way.
Tarn and her colleagues said that it's unclear just how important it is that doctors tell patients about new drugs, since people do get information from pharmacists and other sources, and this study didn't look at what happened after patients left the doctor's office.
More research needs to be done to prove whether better communication by doctors about medicines actually results in proper use of the drugs and improved health outcomes, they wrote.
On the Net: http://archinte.ama-assn.org
(Contact Lee Bowman at BowmanL(at)SHNS.com. Distributed by Scripps Howard News Service, http://www.shns.com)
UCLA Study Shows One-Third Of Drug Ads In Medical Journals Do Not Contain References Supporting Medical Claims
Old News, but worth noting:
Source: University Of California Los Angeles
Date: February 23, 2005
UCLA investigators reviewed pharmaceutical ads in American medical journals and found that nearly one-third contained no references for medical claims; while the majority of references to published material was available, only a minority of company data-on-file documents were provided upon request; and the majority of original research cited in the ads was funded by or had authors affiliated with the product's manufacturer.
In one of the largest studies of its kind, UCLA investigators reviewed pharmaceutical ads in American medical journals to determine what materials are cited in support of medical claims and if those references are available to physicians. Researchers also determined the funding sources of research cited in the ads.
The study is published in the Feb. 15 issue of the Canadian Medical Association Journal.
"Previous studies have shown that physicians' drug prescribing is influenced by pharmaceutical ads. We wanted to see what documents were being used to substantiate the claims and how accessible these were to physicians who may want to verify the research findings," said lead author Dr. Richelle Cooper, assistant clinical professor, Division of Emergency Medicine, David Geffen School of Medicine at UCLA.
Two UCLA investigators independently reviewed 438 ads from 10 American medical journals from 1999 and also reviewed a random sample of 400 references in journal articles from the same publications for comparison.
Researchers found that out of 438 pharmaceutical ads, 126 (29 percent) offered no references in support of medical claims. The most commonly cited references in the ads included journal articles (55 percent) and data-on-file (19 percent), which is a reference to an unpublished company document. Other sources included books; prescribing information such as the Physician's Desk Reference, which annually provides information on drug usage, warnings and drug interactions; government documents; or an Internet site.
Reviewers were able to obtain 84 percent of the referenced documents in the ads. However, researchers could only obtain 20 percent of the data-on-file documents, despite repeated requests to the pharmaceutical companies. The companies responded to 37 out of 88 requests for data-on-file, but more than half of the responses indicated that the information would not be provided due to company policy or because it was proprietary.
"We found that almost one-third of the pharmaceutical ads offered no references at all to support medical claims. In addition, most of the data-on-file documents in support of the medical claims were not available from the drug companies," said Dr. David Schriger, study author and professor of Emergency Medicine at UCLA.
In comparison, out of the 400 journal articles, the most commonly cited sources of references included journal articles (88 percent) and books (8 percent). When reviewers tried to obtain the reference documents, 99 percent were available.
UCLA researchers also checked the funding sources of the original research cited in all the ads and of a random sample of 100 journal articles. Out of 294 ad references citing original research, 58 percent had research sponsored by a pharmaceutical company or had affiliated authors, 19 percent were funded by government or charitable sources and 23 percent had no funding statement at all.
In comparison, 8 percent of the original research reported in these journal issues was funded by a pharmaceutical company or had an author affiliated with the company, and 44 percent was funded by a government or charitable organization.
"We found that the majority of the original research cited in the ads to support medical claims was sponsored by pharmaceutical companies," Cooper said.
Schriger noted that improved monitoring and access to references in pharmaceutical ads may be helpful to physicians and policy makers in making more informed prescribing decisions.
According to the authors, the Federal Drug Administration screens the drug ads for validity, but the sheer volume makes it difficult to adequately check many of the ads. For example, in 2002, the FDA screened more than 34,000 ads.
Journals included in the study: American Journal of Psychiatry, Annals of Emergency Medicine, Annals of Internal Medicine, Annals of Surgery, Hospital Practice, Journal of the American Medical Association, New England Journal of Medicine, Neurology, Obstetrics and Gynecology, and Pediatrics.
There was no external funding for the study.
Source: University Of California Los Angeles
Date: February 23, 2005
UCLA investigators reviewed pharmaceutical ads in American medical journals and found that nearly one-third contained no references for medical claims; while the majority of references to published material was available, only a minority of company data-on-file documents were provided upon request; and the majority of original research cited in the ads was funded by or had authors affiliated with the product's manufacturer.
In one of the largest studies of its kind, UCLA investigators reviewed pharmaceutical ads in American medical journals to determine what materials are cited in support of medical claims and if those references are available to physicians. Researchers also determined the funding sources of research cited in the ads.
The study is published in the Feb. 15 issue of the Canadian Medical Association Journal.
"Previous studies have shown that physicians' drug prescribing is influenced by pharmaceutical ads. We wanted to see what documents were being used to substantiate the claims and how accessible these were to physicians who may want to verify the research findings," said lead author Dr. Richelle Cooper, assistant clinical professor, Division of Emergency Medicine, David Geffen School of Medicine at UCLA.
Two UCLA investigators independently reviewed 438 ads from 10 American medical journals from 1999 and also reviewed a random sample of 400 references in journal articles from the same publications for comparison.
Researchers found that out of 438 pharmaceutical ads, 126 (29 percent) offered no references in support of medical claims. The most commonly cited references in the ads included journal articles (55 percent) and data-on-file (19 percent), which is a reference to an unpublished company document. Other sources included books; prescribing information such as the Physician's Desk Reference, which annually provides information on drug usage, warnings and drug interactions; government documents; or an Internet site.
Reviewers were able to obtain 84 percent of the referenced documents in the ads. However, researchers could only obtain 20 percent of the data-on-file documents, despite repeated requests to the pharmaceutical companies. The companies responded to 37 out of 88 requests for data-on-file, but more than half of the responses indicated that the information would not be provided due to company policy or because it was proprietary.
"We found that almost one-third of the pharmaceutical ads offered no references at all to support medical claims. In addition, most of the data-on-file documents in support of the medical claims were not available from the drug companies," said Dr. David Schriger, study author and professor of Emergency Medicine at UCLA.
In comparison, out of the 400 journal articles, the most commonly cited sources of references included journal articles (88 percent) and books (8 percent). When reviewers tried to obtain the reference documents, 99 percent were available.
UCLA researchers also checked the funding sources of the original research cited in all the ads and of a random sample of 100 journal articles. Out of 294 ad references citing original research, 58 percent had research sponsored by a pharmaceutical company or had affiliated authors, 19 percent were funded by government or charitable sources and 23 percent had no funding statement at all.
In comparison, 8 percent of the original research reported in these journal issues was funded by a pharmaceutical company or had an author affiliated with the company, and 44 percent was funded by a government or charitable organization.
"We found that the majority of the original research cited in the ads to support medical claims was sponsored by pharmaceutical companies," Cooper said.
Schriger noted that improved monitoring and access to references in pharmaceutical ads may be helpful to physicians and policy makers in making more informed prescribing decisions.
According to the authors, the Federal Drug Administration screens the drug ads for validity, but the sheer volume makes it difficult to adequately check many of the ads. For example, in 2002, the FDA screened more than 34,000 ads.
Journals included in the study: American Journal of Psychiatry, Annals of Emergency Medicine, Annals of Internal Medicine, Annals of Surgery, Hospital Practice, Journal of the American Medical Association, New England Journal of Medicine, Neurology, Obstetrics and Gynecology, and Pediatrics.
There was no external funding for the study.
Multiple Sclerosis Damage Also Found In "Normal" Brain Tissue
31 Aug 2006
The effects of multiple sclerosis (MS) extend beyond visibly affected areas into large portions of the brain that outwardly appear normal, according to a study appearing in the September issue of Radiology.
"This disease process in the normal-appearing brain tissue affects the brain globally and has substantial clinical impact," said the study's lead author, Hugo Vrenken, Ph.D., from the Multiple Sclerosis Center at VU University Medical Center in Amsterdam, The Netherlands.
MS is a chronic, autoimmune disease characterized by the destruction of myelin, the protective layers that surround nerve cells. It can affect numerous body functions, and symptoms may include visual and speech impairment, memory loss, depression, muscle weakness, loss of coordination, numbness or pain, bowel and bladder problems and sexual dysfunction.
MS affects approximately 400,000 people in the United States and as many as 2.5 million worldwide, mostly women between the ages of 20 and 50, according to the National Multiple Sclerosis Society.
"The areas of demyelination, or lesions, in patients with MS can be visualized with magnetic resonance imaging (MRI). However, the volume of lesions visible at MRI only correlates moderately with clinical disability measurements," Dr. Vrenken said. "This may be due to disease activity outside the visible lesions."
To gain a better understanding of the effects of MS on the whole brain, Dr. Vrenken and colleagues studied T1 changes in normal-appearing white and gray brain matter in patients with MS.
T1 is a measurement of proton relaxation after exposure to a magnetic field and a radiofrequency (RF) pulse. Due to this RF pulse, protons in the body first reach an excited state and then relax back to a state of equilibrium by funneling the excess energy to the surrounding tissues. T1 refers to the time required for protons to relax to the equilibrium state in this particular manner.
The researchers investigated T1 changes in 67 patients with MS and 24 healthy control volunteers. T1 graphs of normal appearing white and gray matter were significantly different for patients with MS than for controls. Moreover, these graphs differed among patients with MS based on the type of disease: secondary progressive (SP), relapsing-remitting (RR) or primary progressive (PP). The results were most pronounced in patients with SP disease, where at least 31 percent of normal-appearing white matter and 20 percent of cortical normal-appearing gray matter were affected. In RR disease, 16 percent of normal-appearing white matter and 9 percent of cortical normal-appearing gray matter were affected. In PP disease, the normal-appearing white and gray matter affected were 11 percent and 8 percent, respectively. These changes were found throughout the brain, including areas remote from localized lesions that are typically associated with MS.
"These findings demonstrate that in MS, disease processes outside MR-visible lesions are not limited to a few sites but act throughout the brain and affect large fractions of normal-appearing white and gray matter," Dr. Vrenken said. The researchers also explored correlations between the areas of the brain being analyzed in the patients with MS and the level of atrophy or clinical disability present.
"The results suggest that the damage to normal-appearing brain tissue plays a larger role in the progression of atrophy and clinical disability than do the visible lesions," Dr. Vrenken said.
###
Journal attribution required.
Radiology is a monthly scientific journal devoted to clinical radiology and allied sciences. The journal is edited by Anthony V. Proto, M.D., School of Medicine, Virginia Commonwealth University, Richmond, Va. Radiology is owned and published by the Radiological Society of North America, Inc. (RSNA.org/radiologyjnl)
The Radiological Society of North America (RSNA) is an association of more than 38,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill. (RSNA.org - http://rsna.org/)
"Whole-Brain T1 Mapping in Multiple Sclerosis: Global Changes of Normal-appearing Gray and White Matter." Collaborating with Dr. Vrenken on this paper were Jeroen J. G. Geurts, M.Sc., Ph.D., Dirk L. Knol, Ph.D., L. Noor van Dijk, M.D., Vincenzo Dattola, M.D., Bas Jasperse, M.D., Ronald A. van Schijndel, M.Sc., Chris H. Polman, M.D., Ph.D., Jonas A. Castelijns, M.D., Ph.D., Frederik Barkhof, M.D., Ph.D., and Petra J. W. Pouwels, Ph.D.
Contact: Heather Babiar
Radiological Society of North America
Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=50781
The effects of multiple sclerosis (MS) extend beyond visibly affected areas into large portions of the brain that outwardly appear normal, according to a study appearing in the September issue of Radiology.
"This disease process in the normal-appearing brain tissue affects the brain globally and has substantial clinical impact," said the study's lead author, Hugo Vrenken, Ph.D., from the Multiple Sclerosis Center at VU University Medical Center in Amsterdam, The Netherlands.
MS is a chronic, autoimmune disease characterized by the destruction of myelin, the protective layers that surround nerve cells. It can affect numerous body functions, and symptoms may include visual and speech impairment, memory loss, depression, muscle weakness, loss of coordination, numbness or pain, bowel and bladder problems and sexual dysfunction.
MS affects approximately 400,000 people in the United States and as many as 2.5 million worldwide, mostly women between the ages of 20 and 50, according to the National Multiple Sclerosis Society.
"The areas of demyelination, or lesions, in patients with MS can be visualized with magnetic resonance imaging (MRI). However, the volume of lesions visible at MRI only correlates moderately with clinical disability measurements," Dr. Vrenken said. "This may be due to disease activity outside the visible lesions."
To gain a better understanding of the effects of MS on the whole brain, Dr. Vrenken and colleagues studied T1 changes in normal-appearing white and gray brain matter in patients with MS.
T1 is a measurement of proton relaxation after exposure to a magnetic field and a radiofrequency (RF) pulse. Due to this RF pulse, protons in the body first reach an excited state and then relax back to a state of equilibrium by funneling the excess energy to the surrounding tissues. T1 refers to the time required for protons to relax to the equilibrium state in this particular manner.
The researchers investigated T1 changes in 67 patients with MS and 24 healthy control volunteers. T1 graphs of normal appearing white and gray matter were significantly different for patients with MS than for controls. Moreover, these graphs differed among patients with MS based on the type of disease: secondary progressive (SP), relapsing-remitting (RR) or primary progressive (PP). The results were most pronounced in patients with SP disease, where at least 31 percent of normal-appearing white matter and 20 percent of cortical normal-appearing gray matter were affected. In RR disease, 16 percent of normal-appearing white matter and 9 percent of cortical normal-appearing gray matter were affected. In PP disease, the normal-appearing white and gray matter affected were 11 percent and 8 percent, respectively. These changes were found throughout the brain, including areas remote from localized lesions that are typically associated with MS.
"These findings demonstrate that in MS, disease processes outside MR-visible lesions are not limited to a few sites but act throughout the brain and affect large fractions of normal-appearing white and gray matter," Dr. Vrenken said. The researchers also explored correlations between the areas of the brain being analyzed in the patients with MS and the level of atrophy or clinical disability present.
"The results suggest that the damage to normal-appearing brain tissue plays a larger role in the progression of atrophy and clinical disability than do the visible lesions," Dr. Vrenken said.
###
Journal attribution required.
Radiology is a monthly scientific journal devoted to clinical radiology and allied sciences. The journal is edited by Anthony V. Proto, M.D., School of Medicine, Virginia Commonwealth University, Richmond, Va. Radiology is owned and published by the Radiological Society of North America, Inc. (RSNA.org/radiologyjnl)
The Radiological Society of North America (RSNA) is an association of more than 38,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill. (RSNA.org - http://rsna.org/)
"Whole-Brain T1 Mapping in Multiple Sclerosis: Global Changes of Normal-appearing Gray and White Matter." Collaborating with Dr. Vrenken on this paper were Jeroen J. G. Geurts, M.Sc., Ph.D., Dirk L. Knol, Ph.D., L. Noor van Dijk, M.D., Vincenzo Dattola, M.D., Bas Jasperse, M.D., Ronald A. van Schijndel, M.Sc., Chris H. Polman, M.D., Ph.D., Jonas A. Castelijns, M.D., Ph.D., Frederik Barkhof, M.D., Ph.D., and Petra J. W. Pouwels, Ph.D.
Contact: Heather Babiar
Radiological Society of North America
Article URL: http://www.medicalnewstoday.com/medicalnews.php?newsid=50781
New Multiple Sclerosis Treatment Reduces Relapse Rate By 90%
22 Jul 2006
Multiple Sclerosis patients who receive a brief course of Mitoxantrone, and then Copaxone, experience a reduced replase rate of 90%, according to a five-year study carried out at The Walton Centre for Neurology, Liverpool, UK. A further ten controlled studies are being launched at 10 centres in the UK. A reduced relapse rate of 90% means the difference between being bedridden and holding down a job and actively raising a family for many MS patients.
You can read about this study in the Journal of Neurology, August issue.
Mitoxantrone is used for treating cancer patients, it is so powerful that it can only be used for a short time. Copaxone is a slow-acting disease-moderating drug for MS patients. In this study, doctors decided to overlap the treatments because they wanted to give some time for copaxone to build up its effect.
Head researcher, Dr Mike Boggild, said "This regime has proved remarkably effective. Though there are certain risks, associated particularly with use of Mitoxantrone, we have been able to limit these by using this agent for just a short induction period. Balanced against the high risk of early disability for these patients, the outcomes appear to justify this approach.”
Dr. Boggild started treating with Karen Ayres, 28, in 2002. Karen Ayres has MS. Since 2002 she has not suffered any relapses at all. Ayres said she came to see Dr. Boggild during her second relapse. She was unable to walk or feed herself - she was barely able to wave her hand. A few weeks after treatment started she walked out of the rehab centre unaided. She says that since the beginning of this treatment she has managed to lead a completely normal life - she has travelled to five continents and is currently doing a PhD in Psychology at Leeds University, UK.
Ayres was one of 27 patients treated during this open trial. Many of them experienced similar remarkable reductions in relapses.
This study was not a controlled one. This means there was not one group of patients on the drug treatment compared to another group on a placebo. The ten new studies are controlled ones.
The treatment does have potentially serious side-effects, including leukaemia and cardiac problems. However, for many MS patients, it is still worth the risk.
Journal of Neurology
Written by: Christian Nordqvist
Editor: Medical News Today
Article URL: http://www.medicalnewstoday.com/healthnews.php?newsid=47895
Multiple Sclerosis patients who receive a brief course of Mitoxantrone, and then Copaxone, experience a reduced replase rate of 90%, according to a five-year study carried out at The Walton Centre for Neurology, Liverpool, UK. A further ten controlled studies are being launched at 10 centres in the UK. A reduced relapse rate of 90% means the difference between being bedridden and holding down a job and actively raising a family for many MS patients.
You can read about this study in the Journal of Neurology, August issue.
Mitoxantrone is used for treating cancer patients, it is so powerful that it can only be used for a short time. Copaxone is a slow-acting disease-moderating drug for MS patients. In this study, doctors decided to overlap the treatments because they wanted to give some time for copaxone to build up its effect.
Head researcher, Dr Mike Boggild, said "This regime has proved remarkably effective. Though there are certain risks, associated particularly with use of Mitoxantrone, we have been able to limit these by using this agent for just a short induction period. Balanced against the high risk of early disability for these patients, the outcomes appear to justify this approach.”
Dr. Boggild started treating with Karen Ayres, 28, in 2002. Karen Ayres has MS. Since 2002 she has not suffered any relapses at all. Ayres said she came to see Dr. Boggild during her second relapse. She was unable to walk or feed herself - she was barely able to wave her hand. A few weeks after treatment started she walked out of the rehab centre unaided. She says that since the beginning of this treatment she has managed to lead a completely normal life - she has travelled to five continents and is currently doing a PhD in Psychology at Leeds University, UK.
Ayres was one of 27 patients treated during this open trial. Many of them experienced similar remarkable reductions in relapses.
This study was not a controlled one. This means there was not one group of patients on the drug treatment compared to another group on a placebo. The ten new studies are controlled ones.
The treatment does have potentially serious side-effects, including leukaemia and cardiac problems. However, for many MS patients, it is still worth the risk.
Journal of Neurology
Written by: Christian Nordqvist
Editor: Medical News Today
Article URL: http://www.medicalnewstoday.com/healthnews.php?newsid=47895
Monday, September 25, 2006
Biogen Idec Plots its Positioning of Avonex and Tysabri to Maximize Revenues
The New Brands & Strategies: Multiple Sclerosis Report Reveals Critical Commercial Analysis at the Market, Company,
and Brand Level
WALTHAM, Mass. and TORONTO, September 25, 2006 /PRNewswire/ -- Decision Resources and Millennium Research Group find that Biogen Idec must carefully position its two multiple sclerosis drugs, Avonex and Tysabri, to maximize the patient share of both drugs. According to the new report entitled Brands & Strategies: Multiple Sclerosis, Tysabri is expected to be used almost exclusively as a second-line or later treatment option due to its new labeling, which recommends the drug only for patients who have failed to respond to at least one other multiple sclerosis therapy. In order to maximize the sales potential of Tysabri, it will be important for Biogen Idec to position the drug as the first alternative should a patient fail to respond to their initial multiple sclerosis treatment. This would allow Biogen Idec to start patients on Tysabri much sooner than if those patients were to first try switching between various interferon-beta brands and Teva Pharmaceuticals' Copaxone before considering Tysabri.
"Biogen Idec will continue positioning Avonex as the first choice for multiple sclerosis therapy and make Tysabri the first alternative, rather than a high-dose interferon or Teva's Copaxone, should patients fail while taking Avonex," said Craig Speziali, analyst at Millennium Research Group. "This strategy should be effective in maximizing revenues from Biogen Idec's entire multiple sclerosis franchise while potentially capturing patient share away from competitors."
The new report is the first in a series from Decision Resources and Millennium Research Group that reveals critical commercial and competitive analysis at the market, brand, and company level. It is the first initiative between the two companies since Decision Resources bought Millennium Research Group in February of 2006. Brands & Strategies: Multiple Sclerosis covers:
* How leading competitors have positioned their brands for success
* Which multiple sclerosis drugs will continue to succeed in the market
* The launch and level of uptake of biosimilar interferon-beta in the
major markets and which branded drugs will be most affected
* Tysabri's impact on the market and the effect safety concerns have on
its commercial success
* New drugs entering the market between 2005 and 2010 and products being
developed in the major multiple sclerosis competitors' pipelines
About Brands & Strategies
Brands & Strategies is the first and only report series to bring together all the competitive information elements biopharmaceutical companies need to make informed decisions about their own products and next-steps. Each report includes:
* Brand-specific, event-driven, five-year annualized market forecast
* Country-specific market share projections by brand and impacts of future events
* Drug class sales by country
* Brand sales by region
* Projected price for all drugs for five years
* Generic pricing impact on all drugs
* Prevalence and diagnosis rates by country
* Promotional spend for each product
* Pipeline analysis by company within a specific disease
* SWOT analysis on each brand
* Clinical trial reviews and clinical trial competitive analysis
* Detailed brand strategy and how it relates to clinical trial results
* Impact of Medicare
* Selling strategies based on clinical trials
About Millennium Research Group
Millennium Research Group (http://www.MRG.net) is a leading provider of strategic information to the healthcare sector. Focused on the medical device, pharmaceutical, and biotechnology industries, the Company provides its clients with the benefits of its specialized industry expertise through published reports and customized consulting services.
About Decision Resources
Decision Resources, Inc., (http://www.DecisionResources.com) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
CONTACT: Elizabeth Marshall of Decision Resources, Inc., +1-781-296-2563, emarshall@dresources.com
Web site: http://www.decisionresources.com//
Terms and conditions of use apply
Copyright © 2006 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Acorda Therapeutics Announces Positive Results of Phase 3 Study of Fampridine-SR on Walking in People with Multiple Sclerosis
Statistical Significance Achieved on All Three Efficacy Criteria Set Forth in SPA
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sept. 25, 2006--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (34.8 percent vs. 8.3 percent) as measured by the Timed 25-Foot Walk (p less than 0.001). In addition, the effect was maintained in this study throughout the 14-week treatment period (p less than 0.001) and there was a statistically significant improvement in the 12-Item MS Walking Scale (MSWS-12) for walking responders vs. non-responders (p less than 0.001).
The average increase in walking speed over the treatment period compared to baseline was 25.2 percent for the drug group vs. 4.7 percent for the placebo group. Increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS. In addition, statistically significant increases in leg strength were seen in both the Fampridine-SR Timed Walk responders (p less than 0.001) and the Fampridine-SR Timed Walk non-responders (p=0.046) compared to placebo. The Company intends to present comprehensive data at an upcoming medical meeting.
"We are delighted with the results from this trial, which are consistent with Acorda's prior Phase 2 study in people with MS. We will request a meeting with the FDA as soon as possible to discuss next steps for the Fampridine-SR program," said Ron Cohen, M.D., President and CEO. "Acorda is committed to the development of therapies that will improve the function and lives of people with MS, and we wish to thank the physicians and people with MS who participated in this trial."
"Many people with MS experience nerve damage that eventually impairs walking. Currently, no therapies are indicated to improve neurological function, such as loss of mobility, in MS," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "Based on the results of this trial, Fampridine-SR could represent a new way to treat people with MS. In this study, a significantly higher proportion of subjects experienced a consistent improvement in walking speed with Fampridine-SR than with placebo, and this was accompanied by a reduction in the degree of disability that the subjects reported in their daily activities related to mobility."
Special Protocol Assessment (SPA)
This clinical trial was conducted under an SPA from the FDA. The efficacy criteria set forth in the SPA included three elements:
To show that there were significantly more responders in the Fampridine-SR treated group than in the placebo group, as measured by the Timed 25-Foot Walk, a standard neurological test. A responder was defined as someone whose walking speed on the Timed 25-Foot Walk was consistently greater during at least three of four on-drug visits than the person's fastest speed on any of the five off-drug visits.
To demonstrate statistically significant improvement in walking speed on the last on-drug visit for the Fampridine-SR-treated responders compared to the placebo group.
To show that responders reported a significantly greater improvement than non-responders on the MSWS-12, a self-rated assessment of walking disability. This step was meant to validate the clinical meaningfulness of consistent improvement on the Timed 25-Foot Walk.
Study Design
The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The trial, which enrolled 301 individuals at 33 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. The study was open to people with all types of MS, including primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including interferons. Secondary endpoints for the trial included measurements of leg strength. Subjects were randomized to 14 weeks of treatment with Fampridine-SR (n=229) or placebo (n=72), a 3:1 ratio of drug to placebo.
Safety Statement
In this study, adverse events were largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS, including an increased risk of seizures that appears to be dose related. Following is a list of the most common adverse events reported in the study, with percentages representing the Fampridine-SR treatment group vs. the placebo group: falls (15.8 percent vs.15.3 percent), urinary tract infection (13.6 percent vs.13.9 percent), dizziness (8.3 percent vs. 5.6 percent), insomnia (8.3 percent vs. 4.2 percent), fatigue (6.1 percent vs. 2.8 percent), nausea (6.1 percent vs. 4.2 percent), upper respiratory tract infection (6.1 percent vs. 9.7 percent), asthenia (5.7 percent vs. 6.9 percent), back pain (5.7 percent vs. 0 percent), balance disorder (5.7 percent vs. 2.8 percent) and headache (5.7 percent vs. 5.6 percent).
Two serious adverse events that were judged potentially related to treatment and led to discontinuation were anxiety in one subject and a seizure in another subject that was observed during an occurrence of sepsis associated with a urinary tract infection. No deaths occurred during the study. One death was reported for a subject five weeks after the last on-drug study visit. This death occurred outside of the protocol time window for reporting adverse reactions and the cause of death is not known at this time.
About MS
Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.
According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.
For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Approximately 80 percent of people with MS experience some form of walking disability. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and in later stages, about a third of patients are unable to walk.
About Fampridine-SR
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.
Fampridine-SR Mechanism of Action
A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.
In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. Fampridine-SR blocks these exposed channels, and helps the electrical signals to pass through areas of damage.
Conference Call and Webcast
Acorda will hold a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the top-line results from the trial. To access the call, please dial 866-510-0704 (domestic) or 617-597-5362 (international) five minutes prior to the start time, and provide the access code 20529997. A replay of the call will be available from 10:30 a.m. Eastern Time on September 25, 2006 until 11:59 p.m. Eastern Time on October 25, 2006. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 88067926. An audio webcast of the call can also be accessed from the Company's website, at http://www.acorda.com, for the next 30 days.
Patient Information Line
Patients with questions regarding the results of this study, or, who want to join Acorda's mailing list to be kept informed of future company news, may call 877-223-5212, toll-free, weekdays from 10:00am to 5:00pm ET.
Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
CONTACT: Media:
Acorda Therapeutics
Erica Wishner, 914-347-4300 ext. 162
Cell: 914-282-0836
ewishner@acorda.com
or
Porter Novelli
Marion E. Glick, 212-601-8273
Cell: 917-301-4206
marion.glick@porternovelli.com
or
Investors:
Stern Investor Relations
Sarah Lux, 212-362-1200
sarah@sternir.com
SOURCE: Acorda Therapeutics, Inc.
Friday, September 22, 2006
Studies probe new MS treatments
from the Journal of Business - Spokane WA
Specialists here say drugs used for other reasons show promise to help patients
By Rocky Wilson
Research is under way to come up with new drugs to treat multiple sclerosis, of which the Inland Northwest has one of the highest incidence rates in the world, say medical professionals here who specialize in the disease.
Already, inroads have been made in combating symptoms and in slowing the frequency of relapses of the disease, which flares up and subsides without warning, says Dr. Roy Kanter, medical director at the Holy Family Multiple Sclerosis Center, at the North Side medical center.
“Thirteen years ago we had no treatments at all for MS,” says Kanter.
Since then, five drugs for treatment of MS victims have been approved by the U.S. Food and Drug Administration. Last month, the FDA allowed one of the five drugs to be put back on the market. The controversial medication, Tysabri, is believed by Kanter and others to have great potential to increase the time between MS relapses.
Also, the New York City-based National Multiple Sclerosis Society (NMSS) says another about 140 drugs to treat MS are in various stages of clinical testing around the world and studies also are being done on nondrug compounds to address symptoms of the disease.
Sara Bernstein, a science writer for the organization who takes calls from the press for NMSS, says those studies involve drugs to treat both relapsing-remitting MS and the more severe progressive MS, for which no FDA-approved medications currently are available.
Dr. Steven Pugh, director of the Center for Multiple Sclerosis at Rockwood Clinic, says about 60 percent of MS victims have relapsing-remitting MS, in which symptoms arise and then abate, with the cycle repeating itself periodically as the disease slowly takes its toll over a number of years. The other 40 percent is split evenly between those with the more serious progressive form, in which the disease commonly attacks the spinal cord and progresses quickly, and the benign form of the disease, in which fatigue is the main symptom, says Pugh.
Between 1993 and 2001, the FDA approved four MS drugs, BetaSeron, Copaxone, Avonex, and Rebif, all designed to combat immune cells that somehow invade the central nervous system in MS patients and attack nerve cells there, says Dr. Timothy Coetzee, director of research initiatives for the NMSS. He says those drugs have helped cut back on the immune system’s attacks on the brain or spinal cord of MS patients, allowing the time between MS relapses to be extended.
“These drugs either stop or slow the progression of the disease,” says Robert Hansen, director of the Spokane-based Inland Northwest chapter of the National Multiple Sclerosis Society. “They give the patient hope and can hopefully stabilize that person until the cure comes along.”
The number of people diagnosed with MS, especially in the U.S., where access to an individual’s health records is protected by law, is at best a guess. Hansen says about 1,100 MS victims in Spokane County have registered with that nonprofit group, and in the 35-county region his office serves, about 2,300 MS victims have registered.
“We believe the actual number is higher than that,” Hansen says. He says NMSS urges everyone with MS to use at lease one of the five disease-modifying drugs on the market now.
Between them, the Holy Family and Rockwood MS centers provide service to a total of about 1,200 patients.
MS has no cure and its cause is unknown, says Kanter. It occurs when a person’s immune system attacks the myelin sheath surrounding nerve cells, often leading to a loss of motor control or even paralysis. The disease, which can attack any part of the central nervous system, commonly begins with episodes of fatigue, intolerance to heat, double vision, and other symptoms that last weeks or months. It can debilitate sufferers, but rarely kills them. In most cases, sufferers improve slowly until they’re largely free of symptoms, but there’s usually some residual damage to the body, and within weeks, months, or even years the symptoms return, he says.
Pugh believes that when MS is diagnosed, it’s common for more than one disease mechanism to be at work, meaning that there’s more going on at the cellular level that can’t be seen with magnetic resonance imaging scans and isolated with blood tests. He says symptoms are quite different from patient to patient and that the study of genetic defects and genetic codes might explain some of those differences.
“There are currently very few, if any, patient trials under way to look at treatments to repair a damaged brain and spinal cord that is the result of years of damage from MS,” he says. “Most experts believe that the treatment for the chronic damage in MS lies in stem cell research. The inability to progress rapidly with stem cell research is the major roadblock to this type of research.”
MS studies
Three of the more promising clinical studies involve drugs that already have been approved for other uses. Those drugs either attack or regulate one or both of a pair of prominent types of white blood cells, B cells and T cells, that enter the central nervous system of MS victims and do damage. Those B and T cells are common in the human body, says Coetzee.
“In the average person, B cells and T cells are never in the brain or the spinal cord,” says Coetzee. “But in MS patients those cells break through protective barriers in the central nervous system and attack the myelin covers of nerve cells there.” Why that happens is unknown, he says.
Coetzee says B cells in MS patients act differently than B cells in other humans by creating an antibody that attacks myelin cells in the brain and spinal cord. He says Rituxan, which the FDA has approved for treatment of lymphoma as well as some types of arthritis, is a known killer of B cells. He says the MS Rituxan study is aimed at wiping out B cells in hopes of reducing the frequency of MS attacks and reducing the number of MS-caused lesions on the brain.
He says the body will replace B cells destroyed by Rituxan, and there’s hope that those new B cells will no longer produce the damaging antibody. Separate Rituxan studies are testing treatments for people with primary progressive MS and those with relapsing-remitting MS, Coetzee says.
In another trial, Lipitor, a widely used cholesterol-lowering drug, is being studied for its effect on T cells. Coetzee explains there are a family of T cells, one of which, called a T-cell helper, slows other T cells’ attack on the myelin sheath of nerve cells. Coetzee says Lipitor is being studied as an agent that “stimulates production of regulatory T-helper cells.”
The Lipitor study primarily directed at individuals who’re experiencing the earliest stages of the disease, is “very promising,” Coetzee says.
Cladribine, a chemotherapy treatment for some forms of leukemia, also is being studied for possible use in MS patients. That drug destroys both T cells and B cells, thus reducing the number of immune cells that can damage nerve cells in the central nervous system, Coetzee says. It’s hoped the trial will show that the drug will give relapsing-remitting patients “a longer window between attacks,” he says. The long-range effects of clabridine treatment for MS patients are still under study.
The NMSS says non-drug clinical studies geared toward treating MS symptoms include the use of ginseng to help improve cognitive functions and lessen fatigue, stress management to control MS inflammatory activity, and consumption of fish oil to address depression associated with MS.
Tysabri
Tysabri was yanked from the market early last year, just four months after it was introduced, because of potential lethal side effects.
“Tysabri attaches itself to the white blood cells that are primed to attack the myelin covering of the nerve cells. It blocks this attack by never letting them get into the brain,” Kanter says.
Yet, there are risks with Tysabri. Pugh says that during the four months it was on the market, at least one person taking the new drug died after contracting a rare infection that can occur when the immune system is compromised.
He says that Biogen Idec Inc., the Cambridge, Mass.-based company that manufactures Tysabri, had spent more than $1 billion researching the safety of the drug, but pulled it off the market before the FDA ordered it to do so. More tests and studies were conducted, and in July the FDA again approved Tysabri for patient use.
“The benefits of having it available as a drug exceed the risk,” Kanter asserts.
Pugh says, “It’s a very effective medication for the right patients,” adding that patients who experience frequent relapses when they’re first diagnosed with MS are ideal candidates for the drug. He says tests haven’t been done with the drug yet on patients who are in the advanced stages of MS, which can include paralysis, loss of vision, diminished mental capacities, and incontinence, because there’s little hope that Tysabri can undo that damage.
Hansen says, “Tysabri offers neurologists another tool to work with to slow the progression of the disease. We’re excited that there’s another tool, but we’ll leave it up to the doctors to decide who needs to get treated.”
Prolonged buildup
Kanter says, “With the usual progression of the disease, the vast majority of people diagnosed with MS will have problems that build up over years, and many require canes and walkers within 15 to 20 years after their diagnosis.”
He says MS strikes three times more women than men, often first appears when its victims are between the ages of 25 and 40, and people living in Spokane are three times more likely to contract the disease than residents of warm climates.
The disease most commonly strikes individuals of Northern-European ancestry who live north of the 40th parallel, says Kanter. According to Hansen, 95 percent of the Inland Northwest’s population is of Northern European descent. Spokane, of course, is well north of the 40th parallel, which, in the western U.S., stretches roughly from Denver to San Francisco.
Kanter feels an added factor behind the high MS rate here is that Spokane has a “highly informed population” that knows about MS, and people here recognize the disease and report it sooner than residents of other areas.
Eighty percent of MS patients suffer from clinical depression at some point when they have the disease. Kanter says depression is more prevalent among sufferers of MS than among people who are diagnosed with terminal diseases. Hansen attributes the frequency of depression among MS victims to the ongoing uncertainty and grieving associated with the disease. Also, he says, MS patients often experience some loss of brain tissue.
In addition to the possibility of no longer being able to work, MS patients must contend with the high cost of drugs to treat the disease. The four most common MS drugs—BetaSeron, Copaxone, Avonex, and Rebif—cost between $1,500 and $1,800 a month, while Tysabri can cost up to $4,000 a month, says Kanter.
The good news is that pharmaceutical companies usually have programs to help defray such expenses, typically based on patients’ taxable income for the previous year, says Pugh. He’s never heard of a case in which a drug company didn’t help a patient who needed assistance to meet the cost.
Contact Rocky Wilson at (509) 344-1264 or via e-mail at rockyw@spokanejournal.com.
All contents copyright © Journal Of Business
Specialists here say drugs used for other reasons show promise to help patients
By Rocky Wilson
Research is under way to come up with new drugs to treat multiple sclerosis, of which the Inland Northwest has one of the highest incidence rates in the world, say medical professionals here who specialize in the disease.
Already, inroads have been made in combating symptoms and in slowing the frequency of relapses of the disease, which flares up and subsides without warning, says Dr. Roy Kanter, medical director at the Holy Family Multiple Sclerosis Center, at the North Side medical center.
“Thirteen years ago we had no treatments at all for MS,” says Kanter.
Since then, five drugs for treatment of MS victims have been approved by the U.S. Food and Drug Administration. Last month, the FDA allowed one of the five drugs to be put back on the market. The controversial medication, Tysabri, is believed by Kanter and others to have great potential to increase the time between MS relapses.
Also, the New York City-based National Multiple Sclerosis Society (NMSS) says another about 140 drugs to treat MS are in various stages of clinical testing around the world and studies also are being done on nondrug compounds to address symptoms of the disease.
Sara Bernstein, a science writer for the organization who takes calls from the press for NMSS, says those studies involve drugs to treat both relapsing-remitting MS and the more severe progressive MS, for which no FDA-approved medications currently are available.
Dr. Steven Pugh, director of the Center for Multiple Sclerosis at Rockwood Clinic, says about 60 percent of MS victims have relapsing-remitting MS, in which symptoms arise and then abate, with the cycle repeating itself periodically as the disease slowly takes its toll over a number of years. The other 40 percent is split evenly between those with the more serious progressive form, in which the disease commonly attacks the spinal cord and progresses quickly, and the benign form of the disease, in which fatigue is the main symptom, says Pugh.
Between 1993 and 2001, the FDA approved four MS drugs, BetaSeron, Copaxone, Avonex, and Rebif, all designed to combat immune cells that somehow invade the central nervous system in MS patients and attack nerve cells there, says Dr. Timothy Coetzee, director of research initiatives for the NMSS. He says those drugs have helped cut back on the immune system’s attacks on the brain or spinal cord of MS patients, allowing the time between MS relapses to be extended.
“These drugs either stop or slow the progression of the disease,” says Robert Hansen, director of the Spokane-based Inland Northwest chapter of the National Multiple Sclerosis Society. “They give the patient hope and can hopefully stabilize that person until the cure comes along.”
The number of people diagnosed with MS, especially in the U.S., where access to an individual’s health records is protected by law, is at best a guess. Hansen says about 1,100 MS victims in Spokane County have registered with that nonprofit group, and in the 35-county region his office serves, about 2,300 MS victims have registered.
“We believe the actual number is higher than that,” Hansen says. He says NMSS urges everyone with MS to use at lease one of the five disease-modifying drugs on the market now.
Between them, the Holy Family and Rockwood MS centers provide service to a total of about 1,200 patients.
MS has no cure and its cause is unknown, says Kanter. It occurs when a person’s immune system attacks the myelin sheath surrounding nerve cells, often leading to a loss of motor control or even paralysis. The disease, which can attack any part of the central nervous system, commonly begins with episodes of fatigue, intolerance to heat, double vision, and other symptoms that last weeks or months. It can debilitate sufferers, but rarely kills them. In most cases, sufferers improve slowly until they’re largely free of symptoms, but there’s usually some residual damage to the body, and within weeks, months, or even years the symptoms return, he says.
Pugh believes that when MS is diagnosed, it’s common for more than one disease mechanism to be at work, meaning that there’s more going on at the cellular level that can’t be seen with magnetic resonance imaging scans and isolated with blood tests. He says symptoms are quite different from patient to patient and that the study of genetic defects and genetic codes might explain some of those differences.
“There are currently very few, if any, patient trials under way to look at treatments to repair a damaged brain and spinal cord that is the result of years of damage from MS,” he says. “Most experts believe that the treatment for the chronic damage in MS lies in stem cell research. The inability to progress rapidly with stem cell research is the major roadblock to this type of research.”
MS studies
Three of the more promising clinical studies involve drugs that already have been approved for other uses. Those drugs either attack or regulate one or both of a pair of prominent types of white blood cells, B cells and T cells, that enter the central nervous system of MS victims and do damage. Those B and T cells are common in the human body, says Coetzee.
“In the average person, B cells and T cells are never in the brain or the spinal cord,” says Coetzee. “But in MS patients those cells break through protective barriers in the central nervous system and attack the myelin covers of nerve cells there.” Why that happens is unknown, he says.
Coetzee says B cells in MS patients act differently than B cells in other humans by creating an antibody that attacks myelin cells in the brain and spinal cord. He says Rituxan, which the FDA has approved for treatment of lymphoma as well as some types of arthritis, is a known killer of B cells. He says the MS Rituxan study is aimed at wiping out B cells in hopes of reducing the frequency of MS attacks and reducing the number of MS-caused lesions on the brain.
He says the body will replace B cells destroyed by Rituxan, and there’s hope that those new B cells will no longer produce the damaging antibody. Separate Rituxan studies are testing treatments for people with primary progressive MS and those with relapsing-remitting MS, Coetzee says.
In another trial, Lipitor, a widely used cholesterol-lowering drug, is being studied for its effect on T cells. Coetzee explains there are a family of T cells, one of which, called a T-cell helper, slows other T cells’ attack on the myelin sheath of nerve cells. Coetzee says Lipitor is being studied as an agent that “stimulates production of regulatory T-helper cells.”
The Lipitor study primarily directed at individuals who’re experiencing the earliest stages of the disease, is “very promising,” Coetzee says.
Cladribine, a chemotherapy treatment for some forms of leukemia, also is being studied for possible use in MS patients. That drug destroys both T cells and B cells, thus reducing the number of immune cells that can damage nerve cells in the central nervous system, Coetzee says. It’s hoped the trial will show that the drug will give relapsing-remitting patients “a longer window between attacks,” he says. The long-range effects of clabridine treatment for MS patients are still under study.
The NMSS says non-drug clinical studies geared toward treating MS symptoms include the use of ginseng to help improve cognitive functions and lessen fatigue, stress management to control MS inflammatory activity, and consumption of fish oil to address depression associated with MS.
Tysabri
Tysabri was yanked from the market early last year, just four months after it was introduced, because of potential lethal side effects.
“Tysabri attaches itself to the white blood cells that are primed to attack the myelin covering of the nerve cells. It blocks this attack by never letting them get into the brain,” Kanter says.
Yet, there are risks with Tysabri. Pugh says that during the four months it was on the market, at least one person taking the new drug died after contracting a rare infection that can occur when the immune system is compromised.
He says that Biogen Idec Inc., the Cambridge, Mass.-based company that manufactures Tysabri, had spent more than $1 billion researching the safety of the drug, but pulled it off the market before the FDA ordered it to do so. More tests and studies were conducted, and in July the FDA again approved Tysabri for patient use.
“The benefits of having it available as a drug exceed the risk,” Kanter asserts.
Pugh says, “It’s a very effective medication for the right patients,” adding that patients who experience frequent relapses when they’re first diagnosed with MS are ideal candidates for the drug. He says tests haven’t been done with the drug yet on patients who are in the advanced stages of MS, which can include paralysis, loss of vision, diminished mental capacities, and incontinence, because there’s little hope that Tysabri can undo that damage.
Hansen says, “Tysabri offers neurologists another tool to work with to slow the progression of the disease. We’re excited that there’s another tool, but we’ll leave it up to the doctors to decide who needs to get treated.”
Prolonged buildup
Kanter says, “With the usual progression of the disease, the vast majority of people diagnosed with MS will have problems that build up over years, and many require canes and walkers within 15 to 20 years after their diagnosis.”
He says MS strikes three times more women than men, often first appears when its victims are between the ages of 25 and 40, and people living in Spokane are three times more likely to contract the disease than residents of warm climates.
The disease most commonly strikes individuals of Northern-European ancestry who live north of the 40th parallel, says Kanter. According to Hansen, 95 percent of the Inland Northwest’s population is of Northern European descent. Spokane, of course, is well north of the 40th parallel, which, in the western U.S., stretches roughly from Denver to San Francisco.
Kanter feels an added factor behind the high MS rate here is that Spokane has a “highly informed population” that knows about MS, and people here recognize the disease and report it sooner than residents of other areas.
Eighty percent of MS patients suffer from clinical depression at some point when they have the disease. Kanter says depression is more prevalent among sufferers of MS than among people who are diagnosed with terminal diseases. Hansen attributes the frequency of depression among MS victims to the ongoing uncertainty and grieving associated with the disease. Also, he says, MS patients often experience some loss of brain tissue.
In addition to the possibility of no longer being able to work, MS patients must contend with the high cost of drugs to treat the disease. The four most common MS drugs—BetaSeron, Copaxone, Avonex, and Rebif—cost between $1,500 and $1,800 a month, while Tysabri can cost up to $4,000 a month, says Kanter.
The good news is that pharmaceutical companies usually have programs to help defray such expenses, typically based on patients’ taxable income for the previous year, says Pugh. He’s never heard of a case in which a drug company didn’t help a patient who needed assistance to meet the cost.
Contact Rocky Wilson at (509) 344-1264 or via e-mail at rockyw@spokanejournal.com.
All contents copyright © Journal Of Business
Target for new MS drugs revealed
Target for new MS drugs revealed
Scientists say they have found a drug target for new therapies to aid people with multiple sclerosis.
Blocking a cell signal in the nervous system alleviated MS symptoms in mice, the German team told Nature Immunology.
Experts say more work is now needed to check that blocking this signalling molecule, called NF-kB, will achieve the same desired effect in humans.
Every week in the UK about 50 people, typically aged between 20 and 40, are diagnosed with MS.
Immune system malfunction
The exact causes of MS are not known, but it is believed that MS is caused by something foreign to the body, like a virus or a pollutant. This causes the body's immune system to malfunction and start attacking and destroying the protective myelin sheath that coats the nerves in the brain and spinal cord.
The disease affects people differently and symptoms can last for several weeks to several months at a time. Initially MS causes loss of balance, reduced vision and bouts of localised paralysis. Eventually, patients may become totally paralysed and wheelchair-bound.
Scientists have known for some time that NF-kB is involved in MS. But it was not clear whether NF-kB protected the brain cells against the consequences of the disease or aggravated the damage.
To investigate this, Dr Marco Prinz and colleagues studied genetically altered mice with an MS-like condition. In these mice it was possible to turn NF-kB on and off by manipulating two proteins, called IKK2 and NEMO, which activate the molecule. Blocking IKK2 and NEMO, thereby switching off NF-kB, alleviated MS symptoms in the mice.
Given that the human NF-kB signalling network is very similar to that of mice, the researchers believe compounds that inhibit IKK2 and NEMO should be investigated further as potential MS treatments. Dr Prinz said: "NF-kB regulates the production of messengers that are released during inflammation to recruit and activate immune cells. "Generally this is a good strategy to protect the body from infections. But in MS it is exactly these immune cells that cause the problem and their hyperactivation through NF-kB only makes the situation worse."
Chris Jones, chief executive of the MS Trust, said: "This looks exciting. More and more is being discovered about MS at the cell level." However, he stressed that much more work was needed to determine whether the same effects would be seen in humans.
Dr Lee Dunster, head of research and information at the Multiple Sclerosis Society, agreed, saying: "We have to remember that what works in mice does not unfortunately always work in men."
Thursday, September 21, 2006
SERONO'S ORAL CLADRIBINE FAST TRACKED BY FDA
FOR IMMEDIATE RELEASE
SERONO'S ORAL CLADRIBINE FOR THE TREATMENT OF MULTIPLE SCLEROSIS AWARDED FAST TRACK STATUS BY FDA
Geneva, Switzerland, September 21, 2006 - Serono (virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been designated a Fast Track product by the US Food and Drug Administration (FDA). This designation covers patients with relapsing forms of multiple sclerosis.
Serono’s proprietary oral formulation of cladribine for the treatment of multiple sclerosis is currently being evaluated in a multi-center, multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS OrallY) . It is a two-year, double-blind, placebo-controlled study involving over 1,200 patients. Patient enrollment into this pivotal trial is planned to be completed by the end of 2006.
“We are very pleased that oral cladribine has been designated a Fast Track product,” said Ernesto Bertarelli, CEO of Serono. “As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment.”
"Thanks to decades of research, there are injectible drugs available to treat some forms of MS, but there is certainly a need for more and even better therapies to treat all forms of the disease. Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS," said Dr. John Richert, Vice President, Research and Clinical Programs, at the National Multiple Sclerosis Society.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Under Fast Track designation oral cladribine is eligible for Priority Review and FDA may consider for review portions of the marketing application before the New Drug Application (NDA) is completed.
About cladribine
Cladribine is a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis. Through its differentiated mechanism of action, oral cladribine may offer an alternative option to patients with multiple sclerosis.
About multiple sclerosis
Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non- traumatic, neurological disease in young adults. Multiple sclerosis affects approximately two million people worldwide. While symptoms can vary, the most common symptoms of multiple sclerosis include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of multiple sclerosis are the most common.
Background material
For free B-roll, video and other content for Serono and its products, please visit the Serono Media Center www.thenewsmarket.com/Serono. You can download print-quality images and receive broadcast-standard video digitally or by tape from this site. Registration and video is free to the media.
###
Forward-looking statements
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono’s current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Serono’s ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation. Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
###
About Serono
Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif®, Gonal-f®, Luveris®, Ovidrel®/Ovitrelle®, Serostim®, Saizen®, ZorbtiveTM and Raptiva®. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases.
In 2005, Serono, whose products are sold in over 90 countries, achieved worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was US$106.1 million, reflecting a charge of US$725 million taken relating to the settlement of the US Attorney’s Office investigation of Serostim. Excluding this charge as well as other non-recurring items, adjusted net income grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
For more information, please contact:
Corporate Media Relations: Corporate Investor Relations:
Tel: +41 22 739 36 00 Tel: +41 22 739 36 01
Fax: +41 22 739 30 85 Fax: +41 22 739 30 22
http://www.serono.com Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
Media Relations, USA: Investor Relations, USA:
Tel: +1 781 681 2340 Tel: +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
SERONO'S ORAL CLADRIBINE FOR THE TREATMENT OF MULTIPLE SCLEROSIS AWARDED FAST TRACK STATUS BY FDA
Geneva, Switzerland, September 21, 2006 - Serono (virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been designated a Fast Track product by the US Food and Drug Administration (FDA). This designation covers patients with relapsing forms of multiple sclerosis.
Serono’s proprietary oral formulation of cladribine for the treatment of multiple sclerosis is currently being evaluated in a multi-center, multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS OrallY) . It is a two-year, double-blind, placebo-controlled study involving over 1,200 patients. Patient enrollment into this pivotal trial is planned to be completed by the end of 2006.
“We are very pleased that oral cladribine has been designated a Fast Track product,” said Ernesto Bertarelli, CEO of Serono. “As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment.”
"Thanks to decades of research, there are injectible drugs available to treat some forms of MS, but there is certainly a need for more and even better therapies to treat all forms of the disease. Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS," said Dr. John Richert, Vice President, Research and Clinical Programs, at the National Multiple Sclerosis Society.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Under Fast Track designation oral cladribine is eligible for Priority Review and FDA may consider for review portions of the marketing application before the New Drug Application (NDA) is completed.
About cladribine
Cladribine is a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis. Through its differentiated mechanism of action, oral cladribine may offer an alternative option to patients with multiple sclerosis.
About multiple sclerosis
Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non- traumatic, neurological disease in young adults. Multiple sclerosis affects approximately two million people worldwide. While symptoms can vary, the most common symptoms of multiple sclerosis include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of multiple sclerosis are the most common.
Background material
For free B-roll, video and other content for Serono and its products, please visit the Serono Media Center www.thenewsmarket.com/Serono. You can download print-quality images and receive broadcast-standard video digitally or by tape from this site. Registration and video is free to the media.
###
Forward-looking statements
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono’s current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on February 28, 2006. These factors include any failure or delay in Serono’s ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, the outcome of any government investigations and litigation. Serono is providing this information as of the date of this press release, and has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
###
About Serono
Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif®, Gonal-f®, Luveris®, Ovidrel®/Ovitrelle®, Serostim®, Saizen®, ZorbtiveTM and Raptiva®. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases.
In 2005, Serono, whose products are sold in over 90 countries, achieved worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was US$106.1 million, reflecting a charge of US$725 million taken relating to the settlement of the US Attorney’s Office investigation of Serostim. Excluding this charge as well as other non-recurring items, adjusted net income grew 28.4% to US$565.3 million in 2005. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
For more information, please contact:
Corporate Media Relations: Corporate Investor Relations:
Tel: +41 22 739 36 00 Tel: +41 22 739 36 01
Fax: +41 22 739 30 85 Fax: +41 22 739 30 22
http://www.serono.com Reuters: SEO.VX / SRA.N
Bloomberg: SEO VX / SRA US
Media Relations, USA: Investor Relations, USA:
Tel: +1 781 681 2340 Tel: +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
Psychiatric ills common in adults with fibromyalgia
I have run across many people who suffer from multiple sclerosis that also seem to be dealing with fibromyalgia. So here's a recent bit of news:
September 20, 2006
Psychiatric ills common in adults with fibromyalgia
By Amy Norton
NEW YORK (Reuters Health) - Many people with the chronic pain disorder fibromyalgia have also suffered from depression, anxiety or other psychiatric conditions at some point in their lives -- suggesting, researchers say, that the disorders have some common causes.
In a study of 336 adults with and without fibromyalgia, researchers found that those with the condition were substantially more likely to have ever had depression, bipolar disorder or an anxiety disorder. They also had higher rates of eating disorders and substance abuse problems.
In most cases, the psychiatric condition preceded the development of fibromyalgia, making it unlikely that the mood disturbances were simply a reaction to having chronic pain.
Fibromyalgia is a syndrome marked by widespread aches and pains, fatigue and sleep problems, among other symptoms; the cause is unknown, and there are no medications specifically approved for the condition. Treatment usually involves a combination of approaches, such as painkillers, antidepressants, behavioral therapy or exercise therapy.
The new findings, published in the Journal of Clinical Psychiatry, are based on a comparison of families with members affected by either fibromyalgia or rheumatoid arthritis, another condition marked by chronic pain.
Between both groups of families, there were 108 adults, nearly all women, with fibromyalgia and 228 without the condition.
Overall, those with fibromyalgia were almost three times more likely to have ever had major depression and nearly seven times more likely to have suffered an anxiety disorder. They also had a two to three times greater risk of eating disorders and substance abuse problems, and a much higher risk of bipolar disorder.
The associations between fibromyalgia and these psychiatric conditions suggest that there is some "shared vulnerability" at work, according to study chief Dr. Lesley M. Arnold, an associate professor of psychiatry at the University of Cincinnati College of Medicine.
"We are not saying that fibromyalgia is a psychiatric disorder," Arnold told Reuters Health.
Rather, some people may be vulnerable to developing both fibromyalgia and certain psychiatric disorders -- possibly because of genes, Arnold explained, or because of environmental factors such as chronic stress. But no one yet knows for certain.
Still, the evidence suggests that people with fibromyalgia should be screened for psychiatric disorders, according to Arnold. Even when people aren't currently suffering any psychiatric symptoms, their mental health history can influence how their fibromyalgia is treated, she noted.
For example, Arnold explained, medication with both antidepressant and pain-relieving effects might be the first choice for people with a history of depression. Another option is cognitive behavioral therapy, which addresses harmful thought patterns and behaviors; this approach, Arnold said, might help fibromyalgia patients with a history of depression or anxiety disorders.
SOURCE: Journal of Clinical Psychiatry, August 2006.
September 20, 2006
Psychiatric ills common in adults with fibromyalgia
By Amy Norton
NEW YORK (Reuters Health) - Many people with the chronic pain disorder fibromyalgia have also suffered from depression, anxiety or other psychiatric conditions at some point in their lives -- suggesting, researchers say, that the disorders have some common causes.
In a study of 336 adults with and without fibromyalgia, researchers found that those with the condition were substantially more likely to have ever had depression, bipolar disorder or an anxiety disorder. They also had higher rates of eating disorders and substance abuse problems.
In most cases, the psychiatric condition preceded the development of fibromyalgia, making it unlikely that the mood disturbances were simply a reaction to having chronic pain.
Fibromyalgia is a syndrome marked by widespread aches and pains, fatigue and sleep problems, among other symptoms; the cause is unknown, and there are no medications specifically approved for the condition. Treatment usually involves a combination of approaches, such as painkillers, antidepressants, behavioral therapy or exercise therapy.
The new findings, published in the Journal of Clinical Psychiatry, are based on a comparison of families with members affected by either fibromyalgia or rheumatoid arthritis, another condition marked by chronic pain.
Between both groups of families, there were 108 adults, nearly all women, with fibromyalgia and 228 without the condition.
Overall, those with fibromyalgia were almost three times more likely to have ever had major depression and nearly seven times more likely to have suffered an anxiety disorder. They also had a two to three times greater risk of eating disorders and substance abuse problems, and a much higher risk of bipolar disorder.
The associations between fibromyalgia and these psychiatric conditions suggest that there is some "shared vulnerability" at work, according to study chief Dr. Lesley M. Arnold, an associate professor of psychiatry at the University of Cincinnati College of Medicine.
"We are not saying that fibromyalgia is a psychiatric disorder," Arnold told Reuters Health.
Rather, some people may be vulnerable to developing both fibromyalgia and certain psychiatric disorders -- possibly because of genes, Arnold explained, or because of environmental factors such as chronic stress. But no one yet knows for certain.
Still, the evidence suggests that people with fibromyalgia should be screened for psychiatric disorders, according to Arnold. Even when people aren't currently suffering any psychiatric symptoms, their mental health history can influence how their fibromyalgia is treated, she noted.
For example, Arnold explained, medication with both antidepressant and pain-relieving effects might be the first choice for people with a history of depression. Another option is cognitive behavioral therapy, which addresses harmful thought patterns and behaviors; this approach, Arnold said, might help fibromyalgia patients with a history of depression or anxiety disorders.
SOURCE: Journal of Clinical Psychiatry, August 2006.
Wednesday, September 20, 2006
Daily Nicotinamide Shots May Protect Multiple Sclerosis Patients From Severe Disability
20 Sep 2006
Giving multiple sclerosis (MS) patients a daily shot of nicotinamide may protect them from the risk of nerve degeneration and long-term severe disability, say researchers from the Children's Hospital, Boston, USA, who managed to do this with mice with Experimental Autoimmune Encephalitis (symptoms are similar to MS). Nicotinamide is a form of vitamin B3.
You can read about this study in the Journal of Neuroscience.
Anti-inflammatory drugs can help MS patients who are in the relapsing-remitting MS stage. During this stage the patient has bouts of illness, followed by partial or complete recovery. However, when patients are in the Chronic Progressive Phase there is no really effective treatment.
By daily injecting the mice with nicotinamide, the scientists found that their nerve cells were protected from myelin loss. Those cells that had already been affected did not get any worse. They also found that the level of protection correlated with the size of the nicotinamide dosage.
The mice were given a disability scale of 1 to 5 - with 5 being the highest disability level. Those receiving the highest nicotinamide dose scored either 1 or 2, compared with 3 or 4 for those that received no nicotinamide.
The nicotinamide shots enhanced levels of NAD (nicotinamide adenine dinucleotide) in the nervous systems of the mice.
Dr Shinjiro Kaneko, team leader, said "The earlier therapy was started, the better the effect, but we hope nicotinamide can help patients who are already in the chronic stage." He added that more research will be needed to see how effective this procedure might be for humans with MS.
No significant side effects were observed with this treatment.
Journal of Neuroscience
Can a vitamin alleviate chronic, progressive multiple sclerosis?
Ongoing nerve-fiber damage, disability prevented in animal study
Click Here To View Article Online in the Children's Hospital Boston Web Site
Written by: Christian Nordqvist
Editor: Medical News Today
Article URL: http://www.medicalnewstoday.com/healthnews.php?newsid=52348
Giving multiple sclerosis (MS) patients a daily shot of nicotinamide may protect them from the risk of nerve degeneration and long-term severe disability, say researchers from the Children's Hospital, Boston, USA, who managed to do this with mice with Experimental Autoimmune Encephalitis (symptoms are similar to MS). Nicotinamide is a form of vitamin B3.
You can read about this study in the Journal of Neuroscience.
Anti-inflammatory drugs can help MS patients who are in the relapsing-remitting MS stage. During this stage the patient has bouts of illness, followed by partial or complete recovery. However, when patients are in the Chronic Progressive Phase there is no really effective treatment.
By daily injecting the mice with nicotinamide, the scientists found that their nerve cells were protected from myelin loss. Those cells that had already been affected did not get any worse. They also found that the level of protection correlated with the size of the nicotinamide dosage.
The mice were given a disability scale of 1 to 5 - with 5 being the highest disability level. Those receiving the highest nicotinamide dose scored either 1 or 2, compared with 3 or 4 for those that received no nicotinamide.
The nicotinamide shots enhanced levels of NAD (nicotinamide adenine dinucleotide) in the nervous systems of the mice.
Dr Shinjiro Kaneko, team leader, said "The earlier therapy was started, the better the effect, but we hope nicotinamide can help patients who are already in the chronic stage." He added that more research will be needed to see how effective this procedure might be for humans with MS.
No significant side effects were observed with this treatment.
Journal of Neuroscience
Can a vitamin alleviate chronic, progressive multiple sclerosis?
Ongoing nerve-fiber damage, disability prevented in animal study
Click Here To View Article Online in the Children's Hospital Boston Web Site
Written by: Christian Nordqvist
Editor: Medical News Today
Article URL: http://www.medicalnewstoday.com/healthnews.php?newsid=52348
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