A Harvard-based study of insurance coverage involving a nationwide sampling of people with multiple sclerosis found that although they had higher than average rates of insurance coverage, many experienced financial strain related to obtaining adequate health care, including paying for their medications.
The study, commissioned by the National MS Society, was conducted by Drs. Lisa Iezzoni and Long Ngo and published in an early online release January 29, 2007 in the journal Multiple Sclerosis.
Study Details: The study was the largest ever undertaken to explore insurance concerns in people with MS. It was based on 30-minute phone interviews with 983 working-age individuals across the U.S. with multiple sclerosis from among the client mailing list of the National MS Society. Most participants were women (79%), white (86%), married or living with a partner (67%), with at least some college education (72%), and unemployed (60%). Half reported having MS for greater than ten years, and most (73%) reported having relapsing-remitting MS. The authors suggested that, since these demographics mirror in many respects those from other well-designed studies, the results can be generalized to the MS population as a whole.
The interview covered questions about MS history, health insurance, disability and life insurance, as well as financial concerns related to obtaining MS medications and other health services.
Findings: A high percentage (96%) of survey participants reported having at least some health insurance, which is a higher rate of coverage than that of the general population, which for all ages is about 86%. However, there is a high level of dependence on governmental programs; about 40% of participants were covered by public health insurance, primarily Medicare and/or Medicaid, in contrast to only 12% of 44-54 year-olds nationwide. (Although this is a smaller age range than that of the study, it provides an approximate comparison.) In addition, about 68% of survey participants reported having life insurance, and 57% had some long-term disability insurance.
Despite the high rate of health insurance, a significant proportion of participants reported high levels of stress and difficulties related to affording health care services and medications. In order to pay for health care needs, 44% reported making other kinds of changes in their lives. Some 21% reported spending less on food, heat and other necessities to pay for health care needs, and 22% did not fill prescriptions or skipped doses of medicine. Over a third reported worrying "a lot" about losing or not having health insurance, about the cost of health insurance, and about whether their health coverage might change.
In writing about their results, the investigators stated that, "These findings suggest that health insurance is often inadequate to meet persons' needs." Commenting on the study, Dr. Nicholas LaRocca, Associate Vice President of Health Care Delivery and Policy Research at the National MS Society said, "This study emphasizes that simply having insurance does not necessarily ensure that a person will be able to afford care and medications that are so important for treating MS. It also confirms the importance of the รข€˜safety net' and our ongoing efforts to improve health insurance coverage for people with MS."
Wednesday, January 31, 2007
Discovery May Lead to Novel Treatments for Inflammatory Diseases
By pinpointing the mechanism through which an intravenous therapy combats chronic inflammatory diseases, researchers have discovered that they may be able to replace the time-consuming infusion therapy with an injection that could be given during a quick office visit. Investigators at Hospital for Special Surgery in New York City have discovered that intravenous immune globulin (IVIG) or antibody therapy works, in part, by attaching to a receptor known as Fc?RIII and blocking the function of interferon gamma, a major inflammatory factor. Only a small component of the IVIG solution, 0.5 percent, is responsible for blocking this receptor.
"The study suggests that it’s not the whole preparation itself, but the immune complexes within the preparation that are causing the therapeutic effect," said Lionel Ivashkiv, M,D,, director of basic research at Hospital for Special Surgery (HSS), who led the study. Instead of using IVIG, which is pooled from thousands of blood donors, clinicians may be able to use small amounts of so-called immune complexes, or even design synthetic drugs that will avoid problems, such as potential exposure to infectious agents, that are associated with using blood products.
The study appears in the January issue of the journal Immunity.
For years, doctors have used IVIG to treat patients with autoimmune and chronic inflammatory diseases, such as dermatomyositis, Kawasaki disease, multiple sclerosis, lupus, chronic lymphocytic leukemia, and idiopathic thrombocytopenic purpura, but just how the therapy works has remained a mystery. Some researchers have shown that IVIG works, in part, by activating a receptor known as Fc?RIIb, which then suppresses auto-antibody-mediated inflammation. HSS researchers wondered whether an immune system protein called interferon gamma (IFN-?) could be involved -- many chronic inflammatory and autoimmune diseases are caused or exacerbated by an overexpression of this protein.
To test their theory, the investigators turned to macrophages, immune cells that engulf bacteria and are stimulated to kill their prey by IFN-?. The researchers found that in test tube studies of macrophages, IVIG could inhibit the action of IFN-? signaling.
Next, they tested the effects of IVIG in mice infected with Listeria monocytogenes, a bacteria that is usually controlled by IFN-?. They found that mice treated with IVIG, because of the suppression of IFN-?, had much more severe infections than mice treated with saline. Experiments in a mouse model of immune thrombocytopenic purpura also revealed that immune globulin inhibited IFN-?. IVIG sparks this inhibition by docking on a receptor called Fc?RIII.
In another experiment, researchers turned their focus to a different question -- which component of IVIG is responsible for its therapeutic effects. IVIG is composed of 99.5 percent monomeric IgG and 0.5 percent so-called immune complexes. The researchers cultured macrophages with the different IVIG components and discovered that the immune complexes were responsible for the suppression of IFN-?.
"This study suggests that we can move away from using these IVIG preparations and generate very defined (synthetic) immune complexes, which have the potential to work better, be easier to deliver, and have fewer problems in terms of the infusion part of the therapy," Ivashkiv said.
Usually, patients must receive IVIG infusions in the hospital setting, which can involve three to four hours per day, for three consecutive days. "IVIG is time intensive, it’s somewhat expensive, and there are sometimes shortages, because it’s a human product," Ivashkiv explained. "A lot of the limitations of the therapy is just the volume and the quantity of the material that is used. Some people get volume overload or severe allergic reactions."
If clinicians can deliver only the active agent of IVIG and/or design immune complexes with recombinant materials, they may be able to avoid many of these problems, say researchers. "It could be done as an injection, as part of an office visit," commented Ivashkiv.
In addition to HSS researchers, investigators from the Weill Medical College of Cornell University and Weill Graduate School of Medicine, Memorial Sloan-Kettering Cancer Center, Beth Israel Deaconess Medical Center, the British Columbia Cancer Agency in Vancouver, and the Walter and Eliza Hall Institute of Medical Research in Australia contributed to the study. A Cancer Research Institute Fellowship and the National Institutes of Health supported the work.
Source: Hospital for Special Surgery
FDA to Monitor Post-Market Drug Safety
By Amanda Gardner
HealthDay Reporter
Tuesday, January 30, 2007; 12:00 AM
TUESDAY, Jan. 30 (HealthDay News) -- In an apparent attempt to address growing criticism of its operations, the U.S. Food and Drug Administration unveiled a set of initiatives Tuesday that are intended to bolster the country's health safety net.
The recommendations include a pilot project to assess the safety of drugs after they're on the market, as well as initiatives to improve communication both within and without the beleaguered agency.
Speaking of the need to build trust, FDA Commissioner, Dr. Andrew C. von Eschenbach, told reporters at a news conference, "The world is changing, so the FDA must change to continually achieve progress in its ability to determine the safety and effectiveness of the products we regulate. These initiatives today are not the whole story or the final chapter, but they are a major part of the story."
But critics quickly countered that the recommendations didn't go far enough.
"The FDA's [report] includes some minor improvements, such as more sharing of safety data with other agencies, but falls dramatically short of the changes needed to overhaul the nation's drug safety system," senior policy analyst Bill Vaughan of Consumers Union said in a prepared statement.
Many of the initiatives announced Tuesday are in response to recommendations in an Institute of Medicine (IOM) report issued in 2006 and prepared at the request of the FDA. Those recommendations included a push for stronger post-marketing surveillance of approved drugs.
"This report represents our deliberate response to the IOM report," said Randall Lutter, acting deputy commissioner for policy at the FDA, at the news conference. "We are in substantial agreement with most of the IOM recommendations."
In addition to the IOM report, the agency has received substantial criticism for post-market safety questions involving the popular painkiller Vioxx, which was eventually withdrawn from the market, and other drugs.
Another drug, the multiple sclerosis medication Tysabri, was pulled from pharmacy shelves in early 2005 after several patients in clinical trials developed a rare but deadly viral infection in the brain. Tysabri was returned to the market in 2006, but under much stricter guidelines.
On Tuesday, the FDA proposed to strengthen the drug safety system with three basic efforts.
First is strengthening the science supporting the FDA's medical product safety system, including new ways to detect and predict adverse events and reassess drug benefits and risks.
"We can move from just counting side effects to actually preventing and controlling them," said Dr. Janet Woodcock, FDA's deputy commissioner and chief medical officer.
This effort also includes a pilot project to assess the safety of new drugs after they've been on the market for 18 months.
"We'll assess this pilot program for wider implementation after we've run several products through it," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research (CDER).
Consumers Union, however, pointed out that most safety problems don't become apparent until a drug has been on the market for five to seven years.
"Reviewing drugs for safety after 18 months is a good start, but we need periodic, consistent reviews of drugs on the market to catch these major safety issues," Vaughan said.
Galson also announced a new data-sharing agreement with the Veterans Administration to "improve patient safety through better access to data." The agreement is expected to be one of several.
The second part of the overall effort involved improving communication among all parties involved in the drug safety process.
Finally, the recommendations called for changing CDER internal culture and instituting organizational and managerial changes.
"We agree with the IOM about the need to improve the culture at FDA and CDER throughout the life cycle of drugs we regulate," Galson said.
Lutter said the agency would issue a report a year from now on how the recommendations are being implemented.
More information
SOURCES: Jan. 30, 2007 Food and Drug Administration teleconference with Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs; Janet Woodcock, M.D., Deputy Commissioner and Chief Medical Officer, FDA; Steven Galson, M.D., Director, Center for Drug Evaluation and Research, FDA; Randall Lutter, Ph.D., Acting Deputy Commissioner for Policy, FDA; statement, Jan. 30, 2007, Consumers Union
EURO AUTOIMMUNE DISEASES THERAPEUTICS MARKET SEES GROWTH
Growth in the European autoimmune diseases therapeutics market is being spurred by ongoing awareness campaigns, the acceptance of biologics by doctors and an expanding patient base.
With over 70 autoimmune diseases including rheumatoid arthritis and multiple sclerosis (MS), there exists tremendous scope in translating current knowledge to producing innovative, efficient and economical therapeutics.
Frost & Sullivan finds that the European Autoimmune Diseases Therapeutics Market earned revenues of $5.40 billion in 2006 and estimates this to reach $18.74 billion in 2013.
“The growing patient population and the need for better treatment options are the major driving forces in market growth,” says Frost & Sullivan Industry Analyst Sylvia Miriyam Findlay.
The estimated prevalence rate of MS in Europe is 83 of 100,000 with the average annual number of new cases pegged at 4.3 per 100,000. Moreover, Europe has 103 million arthritis sufferers, including nearly 2 million with rheumatoid arthritis; resulting in a US$65 billion burden. This situation has created a compelling need for innovative, effective and affordable therapeutics.
“The rising uptake of biologics by physicians will have a significant impact on product sales,” notes Ms. Findlay. “Aggressive campaigns undertaken by the pharmaceutical companies to promote newer biologics are sparking interest among physicians and will propel revenue generation.”
However, the considerable gap between early diagnosis and the actual initiation of therapy remains a critical restraining factor to market growth.
“The complex nature of autoimmune diseases hinders the development of suitable therapeutics,” observes Ms. Findlay. “The scenario is worsened by low awareness among patients and physicians as well as by improper communication about methods of effective disease management.”
A range of continuous medical education programmes will help disseminate information on autoimmune diseases and their clinical and financial implications. Such initiatives will expand diagnosis and, by extension, the patient population being treated. This will be the key to accelerate market penetration.
Report: European Autoimmune Disease Therapeutics Market H045 – 52
Tuesday, January 30, 2007
Stem Cell Therapy Brings Slight Relief
thisistheMidlands.co.uk (UK) - Jan. 29, 2007
AN Oakenshaw man who received treatment in Germany for Multiple Sclerosis before Christmas has noticed a slight improvement in his sight.
Gary Mayrick received controversial stem cell treatment at a clinic in Cologne in October and was told not to expect an immediate improvement in his condition. But he lives in hope.
His wife, Alison, said: "It takes quite a while for stem cells to grow in your body so we were not expecting too much improvement this early.
"There are little things such as his eyesight, which he feels is slightly better."
Mr Mayrick was first diagnosed with the slow progressive form of the disease 10 years ago and is now registered blind, is unable to stand and needs carers to help him through the day.
His family and friends raised the £15,000 needed to travel to Germany for stem cell treatment, which they hope will give Mr Mayrick a better quality of life.
The Multiple Sclerosis Society, as yet, does not recommend the treatment although it believes with more research, stem cells have the potential to help repair damage caused by MS.
New Trial for MS Drug
By VANESSA FRANKO
The Press-Enterprise
People living with multiple sclerosis have to use injections to help control the disease. The method is the only anti-inflammatory treatment available.
But a new clinical trial, which is seeking participants, may help women with MS get rid of the needles.
Researchers hope an estrogen called estriol will help women with relapsing-remitting multiple sclerosis. It marks the first large-scale trial of a sex hormone to treat the disease, according to the National MS Society.
"Pregnancy makes a variety of autoimmune diseases get better," said Dr. Rhonda Voskuhl, who is heading the study at UCLA.
One of the diseases it helps is multiple sclerosis, a disease that attacks the central nervous system. In MS, the myelin sheath around nerves which helps conduct electrical impulse is lost in multiple areas and replaced with scar tissue.
Relapsing-remitting MS is the most common form of the disease, according to the national society. It involves bouts of acute downslides in neurological function, followed by partial or full recovery periods in which the disease no longer progresses.
Voskuhl and a team at UCLA, as well as six other universities around the country, will start enrollment at the end of February for a two-year clinical trial of estriol with about 130 nonpregnant women with MS.
The disease affects two to three times more women than men, according to the National MS Society.
About four years ago, Voskuhl did a small-scale study of estriol with 12 women who had MS.
"We saw an improvement in cognitive functions," she said.
The study also saw an 80 percent reduction in inflamed regions in the brain.
Voskuhl hopes the new estriol study will yield positive results of protecting the nerves and reducing lapses, and not just act to help inflammations.
Estriol is taken in pill form, which would ultimately be cheaper than current treatments. Voskuhl said injection treatments can cost a patient anywhere from $12,000 to $20,000 each year.
Leon LeBuffe, president of the Southern California chapter of the National MS Society, said that the cost and needles are two of the biggest objections patients have to current treatment.
Throughout the study, women will take a daily shot of the anti-inflammatory drug Copaxone as well as an estriol pill or a placebo.
"Nobody gets less than the standard of care," Voskuhl said.
The estriol trial is one of the prominent research projects going on for multiple sclerosis, and has a price tag of $4.7 million, according to the Southern California Chapter of the National MS Society.
The chapter has promised to raise the money for the study and has already made a "rescue" pledge of $667,000 to start the trial, said Marni Deckter, communications director for the chapter.
"For us, it's a huge task to raise this much money," LeBuffe said.
Enrollment for the study is slated to begin in late February at UCLA, Wayne State University in Detroit, Washington University in St. Louis, University of Chicago, University of Utah in Salt Lake City, Robert Wood Johnson Medical School in New Jersey and Ohio State University in Columbus.
Reach Vanessa Franko at 951-368-9575 or at vfranko@PE.com
Qualifications for participating in estriol study:
Women diagnosed with relapsing-remitting MS, ages 18-50
No previous treatment with Copaxone
No interferon treatment, unless newly diagnosed and treated for less than three months
The Press-Enterprise
People living with multiple sclerosis have to use injections to help control the disease. The method is the only anti-inflammatory treatment available.
But a new clinical trial, which is seeking participants, may help women with MS get rid of the needles.
Researchers hope an estrogen called estriol will help women with relapsing-remitting multiple sclerosis. It marks the first large-scale trial of a sex hormone to treat the disease, according to the National MS Society.
"Pregnancy makes a variety of autoimmune diseases get better," said Dr. Rhonda Voskuhl, who is heading the study at UCLA.
One of the diseases it helps is multiple sclerosis, a disease that attacks the central nervous system. In MS, the myelin sheath around nerves which helps conduct electrical impulse is lost in multiple areas and replaced with scar tissue.
Relapsing-remitting MS is the most common form of the disease, according to the national society. It involves bouts of acute downslides in neurological function, followed by partial or full recovery periods in which the disease no longer progresses.
Voskuhl and a team at UCLA, as well as six other universities around the country, will start enrollment at the end of February for a two-year clinical trial of estriol with about 130 nonpregnant women with MS.
The disease affects two to three times more women than men, according to the National MS Society.
About four years ago, Voskuhl did a small-scale study of estriol with 12 women who had MS.
"We saw an improvement in cognitive functions," she said.
The study also saw an 80 percent reduction in inflamed regions in the brain.
Voskuhl hopes the new estriol study will yield positive results of protecting the nerves and reducing lapses, and not just act to help inflammations.
Estriol is taken in pill form, which would ultimately be cheaper than current treatments. Voskuhl said injection treatments can cost a patient anywhere from $12,000 to $20,000 each year.
Leon LeBuffe, president of the Southern California chapter of the National MS Society, said that the cost and needles are two of the biggest objections patients have to current treatment.
Throughout the study, women will take a daily shot of the anti-inflammatory drug Copaxone as well as an estriol pill or a placebo.
"Nobody gets less than the standard of care," Voskuhl said.
The estriol trial is one of the prominent research projects going on for multiple sclerosis, and has a price tag of $4.7 million, according to the Southern California Chapter of the National MS Society.
The chapter has promised to raise the money for the study and has already made a "rescue" pledge of $667,000 to start the trial, said Marni Deckter, communications director for the chapter.
"For us, it's a huge task to raise this much money," LeBuffe said.
Enrollment for the study is slated to begin in late February at UCLA, Wayne State University in Detroit, Washington University in St. Louis, University of Chicago, University of Utah in Salt Lake City, Robert Wood Johnson Medical School in New Jersey and Ohio State University in Columbus.
Reach Vanessa Franko at 951-368-9575 or at vfranko@PE.com
Qualifications for participating in estriol study:
Women diagnosed with relapsing-remitting MS, ages 18-50
No previous treatment with Copaxone
No interferon treatment, unless newly diagnosed and treated for less than three months
Opexa Achieves Midpoint in Patient Admissions in Phase IIb Trial of Tovaxin for Multiple Sclerosis
THE WOODLANDS, Texas--(BUSINESS WIRE)--Jan 30, 2007 - Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, announced today that it has admitted the first 75 patients in its 150-patient Phase IIb clinical trial of Tovaxin(TM) in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 34 trial sites in the U.S., all of which are actively recruiting patients.
David McWilliams, president and chief executive officer of Opexa, commented, "Given the efficacy and safety demonstrated in our Phase I/II study of Tovaxin and the emerging understanding in the scientific literature of the involvement of pathogenic T-cells in multiple sclerosis, this trial has been highly anticipated in the MS community. We are excited about the enrollment interest we are receiving and feel comfortable that we will be able to achieve our 100% enrollment goal in the first half of this year."
Jim Williams, Ph.D., chief operating officer of Opexa, commented, "We are pleased to have reached this important milestone in our clinical program for the development of Tovaxin as a first line therapy for multiple sclerosis. The admission of 75 patients into the Phase IIb trial attests to the ability of Opexa to organize its clinical trials, including patient recruitment, site selection and manufacturing capacity as we meet the challenge of developing a patient-specific autologous T-cell vaccination therapy for multiple sclerosis."
As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.
All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin(TM), a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for type 1 diabetes.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
Bruce Voss, 310-691-7100
bvoss@lhai.com
Family Members with MS Likely to Share Onset Age, but Not Disease Severity
ST. PAUL, MN -- January 30, 2007 -- When more than one member of a family is affected by multiple sclerosis (MS), their ages at disease onset are likely to be similar, but disease severity may not be. These new findings have important implications for counseling patients, according to a study published in the January 30, 2007, issue of Neurology®, the scientific journal of the American Academy of Neurology.
"We've known for some time that family influence plays a role in whether you are susceptible to MS, but it has not been clear whether your family influence affects the course of the disease," according to lead study author Alastair Compston, PhD, of the University of Cambridge Clinical School in Cambridge, United Kingdom.
To address the question of family influence on the course of the disease, researchers examined data on 2,310 individuals from over 1,000 families in which at least two members had MS. They examined age at onset, disability, disease severity, and other features of the disease.
The researchers found that age at onset of the disease was similar among family members, whether comparing parents to children or siblings with each other. They also found that siblings tended to have the same pattern of disease progression, while there was no correlation between the pattern in parents and children.
The study also showed there was no correlation between the severity of the disease in one family member and severity in another member, whether siblings or parent and child. "Disease progression is often considered the indicator of severity," said Compston. "But, we found no evidence that disease severity is more likely to be similar between two family members with MS than two unrelated people with MS."
The causes of the similarities in onset and progression pattern are largely unknown, as are the causes of MS itself. It is possible that genetic factors are responsible, but environmental factors shared by family members may also play a role.
Compston says the study's findings have significant implications for counseling patients. "People should not draw personal conclusions for their own MS prognosis and expected disease severity from observing the condition of their relatives with MS," he said.
The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease, and multiple sclerosis.
SOURCE: American Academy of Neurology
Parkinson's, MS more common than thought
U.S. survey boosts estimates of major neurological diseases
WASHINGTON - Multiple sclerosis, Parkinson’s disease and other neurological diseases may be far more common than most people had believed, according to the latest estimates.
Nearly one out of 1,000 Americans has multiple sclerosis or MS and one out of 100 elderly Americans has Parkinson’s disease the survey found.
“Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982,” said Dr. Deborah Hirtz of the National Institute of Neurological Disorders and Stroke, who led the survey.
It is not clear whether the disease is actually more common or if it is being diagnosed more accurately, she said.
Alzheimer's rate up — and still rising.
The new survey, published in the journal Neurology, also found the rate of Alzheimer’s disease was up substantially from past estimates, with 67 out of 1,000 Americans over the age of 65 affected.
Nearly 10 out of 1,000 older Americans have Parkinson’s disease, and four out of every 100,000 has amyotrophic lateral sclerosis, also called ALS or Lou Gehrig’s disease, the survey found.
The survey projects that the number of people with Parkinson’s will double from about 4.3 million people now to 9 million people worldwide over the next 25 years.
It corroborated other studies on childhood neurological disorders, finding that nearly six out of every 1,000 children has autism, and two out of every 1,000 children has cerebral palsy.
Hirtz and colleagues reviewed studies from nearly 500 medical papers published between 1990 and 2005 for their report.
They found that 101 out of every 100,000 Americans has a traumatic brain injury each year, 50 percent fewer than previous estimates.
More than 180 out of every 100,000 people suffer a stroke each year, and close to five out of every 100,000 have a new spinal cord injury each year.
Steven Albert of the Department of Behavioral and Community Health Sciences at the University of Pittsburgh said the impact of Alzheimer’s will be substantial as the population ages.
“Current projections of AD (Alzheimer’s disease) suggest that there will be about 10 million cases in the United States in 2050, of which 6 million are expected to have moderate or severe dementia,” Albert wrote in a commentary in the journal.
There is currently no cure and treatments only delay the progression of Alzheimer’s slightly. There is also no cure for MS or for Parkinson’s, although drugs can also delay their progression.
Copyright 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.
Monday, January 29, 2007
Investors, Caution: Biologics Have Side Effects Too
Centient Biotech Investor submits: It is generally assumed that biological substances are intrinsically less toxic than small molecule drugs. And it is not just doctors and patients who share this notion. Biologics sail through approvals quicker, and they get to market sooner than small molecules do.
These differences are the main reason small companies like biologics. They can hope to bring biologics to market, whereas none would even contemplate doing the same with a small molecule drug. The process is just too involved.
These ideas about safety and lack of toxicity are so widely held that nobody thought bad things could happen to Elan (ELN) and Biogen-Idec (BIIB)'s new drug for multiple sclerosis before its approval. And when Tysabri was withdrawn, many were stunned that a biologic apparently could have serious side-effects. This may also be one of the reasons why so many over-reacted to the news. Tysabri is coming back to the clinic, albeit in a more restricted way.
It is not that people thought these molecules were totally harmless. It was always well understood and well publicized that any protein drug or vaccine could cause hypersensitivity reactions or even an occasional severe or deadly anaphylactic shock. But apart from these rather rare complications, most thought that, being natural products, biologics would do no harm per se. Furthermore, some biologics are just used to replace or supplement existing natural substances, so what could be the harm in that?
Biologics' Loss of Innocence
It seems biologics are losing their innocence and very quickly so. As more people start using these drugs and they are entering the mainstream of medicine, it appears that biologics will be no different from other drugs. It may well have been the rather restricted use so far that has lulled everyone into thinking biologics are safer. Maybe there is really no difference in terms of unwanted and potentially harmful or deadly side-effects between biologics and small molecules. A biologics' provenance in nature seems to provide little advantage in these matters.
Just this week Genentech (DNA) posted a Dear Doctor letter warning of increased risk of stroke when using blindness drug Lucentis. The increased risk was most noticeable in the higher dose category, but that is precisely where all the marketing and all the prescriptions are. Genentech says it is not sure Lucentis causes stroke but there were many more strokes in people using the drug than controls. The difference was statistically very significant. Lucentis is an anti-VEGF antibody used for "wet" age related macular degeneration. It is essentially a modified version of the company's anticancer drug Avastin, optimized for local intra-ocular use.
Bad News for Genetech and Amgen
The news is not good for Genentech, because Lucentis is actually performing better in the market than its cousin Avastin. Also, Avastin is used for cancer, an indication where doctors and patients have much higher tolerance for side-effects. Despite its clear efficacy, Avastin has disappointed some analysts with its slow growth. Not so, Lucentis. Until now, that is.
It is possible that Lucentis damages blood vessels as it has been found that vascular endothelial growth factor [VEGF] is needed to support existing vessels as well as to grow new ones. Damaging a vessel's interior lining could certainly lead to occlusions and stroke. It had already been noted that Avastin increased the risk for heart attacks and strokes (see story), and Genentech added a warning to that effect. It seems plausible the same could happen to Lucentis.
Amgen (AMGN) also had to admit this week that its newer epoetin version Aranesp increases the risk of death when used to treat certain cancer patients. It had been noted before that correcting anemias in kidney failure patients to normal levels of hemoglobin led to increased complications and death. An article in the New England Journal of Medicine in November of last year found that kidney patients treated aggressively had a 34% higher risk of heart problems or death. And that is a case where doctors are essentially using an almost identical version of a natural hormone to correct a disease to near normal conditions.
The experience has prompted renal specialists to re-evaluate how to treat kidney patients and how much to treat them. In this latest trial by Amgen, patients whose anemia was caused by cancer were targeted. So far, Aranesp and the older epo-versions are only approved for anemias caused by chemotherapy for cancer. Amgen had clearly hoped to expand its label to those patients whose cancer is causing anemia. But it now appears that this may not be a safe thing to do.
It also seems clear that everyone is a bit overconfident in biologics when it comes to side-effects and toxicity. The fact that some of these products are near-identical versions of existing hormone and natural factors apparently does not mean it is safe to use them in all cases. Not even when such use only attempts to correct a well documented deficit or problem in a seemingly "natural" way.
While Amgen and Genentech remain two of our favorite large biotechs, their performance this week illustrates how negative news regarding a single block buster drug in a company's portfolio can create large swings in value. Investors would also do well to be a bit more cautious when it comes to side-effects for biologics in general. Now that these drugs are entering bigger markets and more common indications, we could well see a surge in adverse effects that may lead to warnings or even withdrawals. It is no longer safe to assume that a biologic can just expand its market forever by adding more and more indications without worrying about adverse effects.
Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.
Autoimmune Disease Breakthrough Gained By Identification Of 30 Errant Genes
A report in the January issue of Nature magazine announces that one more step in understanding what may cause the body to attack itself in its war against autoimmune disease has been discovered by researchers at the Massachusetts Institute of Technology's Whitehead Institute, says the Autoimmune Related Diseases Association (AARDA), a national nonprofit patient advocacy organization.
What happens in certain cases to cause the body's immune system to go wild with an over reaction when it encounters invading viruses or bacteria, thus resulting in one or more autoimmune diseases--such as rheumatoid arthritis, lupus, multiple sclerosis, thyroid disease (Graves', Hashimoto's), juvenile (type 1) diabetes?
Researchers Richard Young and Alexander Marson, an M.D./Ph.D. student working in Young's laboratory, have reported discovering 30 genes that go awry in autoimmune diseases. According to Young, the regulatory T cells (called "T regs") that normally control the immune system may have genetic defects. In that case, the T regs protective powers are weakened.
The "brain" of the T regs is a protein called Foxp3. It can send the message to increase or decrease the production of other genes. Dr. Marson, study lead author, said, "We identified a set of roughly 30 genes that are clearly regulated by Foxp3 and, surprisingly, a lot of them are suppressed by Foxp3." Mutation in more of the genes, PTPN22, is associated with a number of autoimmune disorders. It is speculated that altering the Foxp3 gene might be one way to reach a cure of autoimmune diseases.
Two significant implications have emerged from this research. Marson commented, "One is that we've identified this core set of genes that are probably likely to play key roles in preventing autoimmune more disease." He added, "The second implication, which is maybe more long-term, is that we hope that identifying these targets will allow us to screen for drugs to mimic the function of Foxp3 and, thus, treat autoimmune disease."
Autoimmune disease pioneer Noel R. Rose, M.D., Director of the Johns Hopkins Center for Autoimmune Disease Research, says that treating autoimmune disorders will require enhancing either the number or effectiveness of regulatory T cells. He remarked that the MIT study is "certainly important in trying to understand how these regulatory T cells work." He cautions, "Whether this will have important functional implications, only time will tell."
Commenting on the study results, Virginia Ladd, AARDA president and executive director, observes, "The discovery adds weight to the reason why autoimmune diseases should be considered a disease category similar to the way that cancer is viewed rather than as singular diseases." She adds, "It also lends proof to the genetic connection among these diseases and an understanding as to why these diseases run in families."
Ms. Ladd points out that the public is unaware of the genetic connection among various autoimmune diseases, and patients are seldom queried by healthcare professionals regarding the family history in autoimmune disease. AARDA is pressing for federal legislation that would bring more awareness to autoimmune diseases and the fact that collectively they affect millions of Americans.
American Autoimmune Related Diseases Association (AARDA)
Michigan National Bank Bldg., 15475 Gratiot Ave.
Detroit, MI 48205
United States
http://www.aarda.org/
TeGenero trial: could 'memory' T-cells be the missing link?
Prior activation of human T-cells could be the reason for the severe adverse reactions triggered by TeGenero's monoclonal antibody TGN1412 in a Phase I trial at London's Northwick Park Hospital last March.
The hypothesis is based on research by a team from Imperial College London, King's College London and the Cambridge-based Babraham Institute. It offers a possible explanation as to why the 'cytokine storm' that left six healthy volunteers in intensive care after taking TGN1412 did not occur in animal studies, even though cynomolgus monkeys were given 500 times the dose administered to humans.
The therapeutic potential of TGN1412 rested on its ability to activate immune-mediating T-cells by binding to the CD28 antigen on these cells. The theory was that, by targeting CD28, TGN1412 could overstimulate the rogue T-cells responsible for the autoimmune response in chronic inflammatory conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, making these cells "burn out and die", the researchers noted.
This process was complicated, however, when the T-cells were 'memory cells' - meaning they had already been activated or altered in the past by infection or illness. Some 50% of adult human T-cells are memory cells, whereas animal models - such as those used to calculate the dose for human exposure to TGN1412 - have few memory T-cells, as they are deliberately kept in a sterile environment where they are shielded from infections, the research team pointed out.
When the scientists artificially stimulated the CD28 antigen on memory T-cells and injected them into healthy mice, the cells immediately migrated from the bloodstream into organs where there was no infection, such as the heart, kidney and gut, causing significant tissue damage. This could explain why a drug that appeared relatively safe in animals had a disastrous effect in humans, as the more prevalent memory T-cells "lost their sense of direction and started migrating into several areas of the body they were not supposed to go", they suggested.
The study, led by Dr Federica Marelli-Berg from the Department of Immunology at Imperial College London, was presented at the Club de la Transplantation conference in Cernay la Ville, France. Last year an independent Expert Scientific Group convened by the UK government in the wake of the TeGenero study recommended a number of additional safeguards for first-in-man trials of potentially higher-risk compounds, such as information sharing, regulatory access to independent expertise and a conservative approach to drug dosing.
ReceptoPharm Begins Phase IIb Human Clinical Trial for the Treatment of Adrenomyeloneuropathy
ReceptoPharm Begins Phase IIb Human Clinical Trial for the Treatment of Adrenomyeloneuropathy
BOCA RATON, Fla.--(BUSINESS WIRE)--Nutra Pharma Corp. (OTCBB:NPHC), a biotechnology company that is developing drugs for HIV and Multiple Sclerosis has today announced that ReceptoPharm had commenced its Phase IIb clinical trial in subjects with Adrenomyeloneuropathy (AMN).
“The AMN trial is important for ReceptoPharm, as its protocol will also allow us to assess the potential effects of RPI-78M in Multiple sclerosis,” explained Paul Reid, CEO of ReceptoPharm, Inc. “We are happy it is underway and, given our prior clinical experiences, we are very positive about the future outcome of this trial,” he added.
RPI-78M is ReceptoPharm’s lead drug candidate for the treatment of neurological disorders. The Company announced regulatory approval to begin its Phase IIb trial in April 2006, but was later delayed by contract drug fillers and the British Medicines and Health Regulatory Agency’s (MHRA) need for certification of the clinical drug batch prior to starting the trial.
“We are pleased that the MHRA feels comfortable with our safety data and has given us the final endorsement to begin our trial,” commented Rik J. Deitsch, Chairman and CEO of Nutra Pharma Corporation. “The commencement of this trial provides the foundation for initiating several additional clinical trials that we have scheduled for 2007,” he concluded.
There is currently no approved treatment for Adrenomyeloneuropathy. Additionally, the disease's rarity designates it as an orphan drug candidate both in Europe and in the U.S. ReceptoPharm has applied for Orphan drug status in the U.S. and intends doing so for the EU.
About Nutra Pharma Corp.
Nutra Pharma Corp. is a biopharmaceutical company specializing in the acquisition, licensing and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune and infectious diseases. Nutra Pharma Corp. through its subsidiaries carries out basic drug discovery research and clinical development and also seeks strategic licensing partnerships to reduce the risks associated with the drug development process. The Company's holding, ReceptoPharm, Inc, is developing technologies for the production of drugs for HIV and Multiple Sclerosis ("MS"). The Company's subsidiary, Designer Diagnostics is engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious diseases such as Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma continues to identify and acquire intellectual property and companies in the biotechnology arena.
http://www.NutraPharma.com
http://www.ReceptoPharm.com
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). The start of the ReceptoPharm Phase IIb human clinical trial for the treatment of Adrenomyeloneuropathy should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
Contacts
Nutra Pharma Corp.
David Isserman (Investor Relations), 877-895-5647
IR@nutrapharma.com
Friday, January 26, 2007
Discovery May Lead to Novel Treatments for Autoimmune and Chronic Inflammatory Diseases
Newswise — By pinpointing the mechanism through which an intravenous therapy combats chronic inflammatory diseases, researchers have discovered that they may be able to replace the time-consuming infusion therapy with an injection that could be given during a quick office visit. Investigators at Hospital for Special Surgery in New York City have discovered that intravenous immune globulin (IVIG) or antibody therapy works, in part, by attaching to a receptor known as FcฮณRIII and blocking the function of interferon gamma, a major inflammatory factor. Only a small component of the IVIG solution, 0.5%, is responsible for blocking this receptor.
“The study suggests that it’s not the whole preparation itself, but the immune complexes within the preparation that are causing the therapeutic effect,” said Lionel Ivashkiv, M,D,, director of Basic Research at Hospital for Special Surgery (HSS) who led the study. Instead of using IVIG, which is pooled from thousands of blood donors, clinicians may be able to use small amounts of so-called immune complexes, or even design synthetic drugs that will avoid problems, such as potential exposure to infectious agents, that are associated with using blood products.
The study appears in the January issue of the journal Immunity.
For years, doctors have used IVIG to treat patients with autoimmune and chronic inflammatory diseases, such as dermatomyositis, Kawasaki disease, multiple sclerosis, lupus, chronic lymphocytic leukemia, and idiopathic thrombocytopenic purpura, but just how the therapy works has remained a mystery. Some researchers have shown that IVIG works, in part, by activating a receptor known as FcฮณRIIb, which then suppresses auto-antibody-mediated inflammation. HSS researchers wondered whether an immune system protein called interferon gamma (IFN-ฮณ) could be involved—many chronic inflammatory and autoimmune diseases are caused or exacerbated by an overexpression of this protein.
To test their theory, the investigators turned to macrophages, immune cells that engulf bacteria and are stimulated to kill their prey by IFN-ฮณ. The researchers found that in test tube studies of macrophages, IVIG could inhibit the action of IFN-ฮณ signaling.
Next, they tested the effects of IVIG in mice infected with Listeria monocytogenes, a bacteria that is usually controlled by IFN-ฮณ. They found that mice treated with IVIG, because of the suppression of IFN-ฮณ, had much more severe infections than mice treated with saline. Experiments in a mouse model of immune thrombocytopenic purpura also revealed that immune globulin inhibited IFN-ฮณ. IVIG sparks this inhibition by docking on a receptor called FcฮณRIII.
In another experiment, researchers turned their focus to a different question—which component of IVIG is responsible for its therapeutic effects. IVIG is composed of 99.5% monomeric IgG and 0.5% so-called immune complexes. The researchers cultured macrophages with the different IVIG components and discovered that the immune complexes were responsible for the suppression of IFN-ฮณ.
“This study suggests that we can move away from using these IVIG preparations and generate very defined (synthetic) immune complexes, which have the potential to work better, be easier to deliver, and have fewer problems in terms of the infusion part of the therapy,” Dr. Ivashkiv said.
Usually, patients must receive IVIG infusions in the hospital setting, which can involve three to four hours per day, for three consecutive days. “IVIG is time intensive, it’s somewhat expensive, and there are sometimes shortages, because it’s a human product,” Dr. Ivashkiv explained. “A lot of the limitations of the therapy is just the volume and the quantity of the material that is used. Some people get volume overload or severe allergic reactions.”
If clinicians can deliver only the active agent of IVIG and/or design immune complexes with recombinant materials, they may be able to avoid many of these problems, say researchers. “It could be done as an injection, as part of an office visit,” commented Dr. Ivashkiv.
In addition to HSS researchers, investigators from the Weill Medical College of Cornell University and Weill Graduate School of Medicine, Memorial Sloan-Kettering Cancer Center, Beth Israel Deaconess Medical Center, the British Columbia Cancer Agency in Vancouver, and the Walter and Eliza Hall Institute of Medical Research in Australia contributed to the study. A Cancer Research Institute Fellowship and the National Institutes of Health supported the work.
About HSS
Founded in 1863, Hospital for Special Surgery is a world leader in orthopedics, rheumatology and rehabilitation. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Medical College of Cornell University, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All HSS medical staff are on the faculty of Weill Medical College of Cornell University. Its Research Division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. The hospital is located in New York City. For more information, visit http://www.hss.edu.
© 2007 Newswise. All Rights Reserved.
Cannabis trio freed by court
Published on 26/01/2007
THREE people who supplied thousands of chocolate bars laced with cannabis to multiple sclerosis sufferers walked free from court today.
Mark Gibson, his wife Lezley, both 42, who has multiple sclerosis (MS), from Alston, and Marcus Davies, 36, were each given a nine-month jail term, suspended for two years.
All three defendants argued that the drug eased the symptoms of MS and believed they had a defence of medical necessity but this was rejected by a jury last month.
Sentencing today at Carlisle Crown Court, Judge John Phillips said he accepted their motives were “altruistic”, that they had a genuine desire to help people who were suffering and that no profit was made from the operation.
Carbon monoxide may protect against MS symptoms
14:00 26 January 2007
NewScientist.com news service
Roxanne Khamsi
Journal of Clinical Investigation
Miguel Soares, Gulbenkian Science Institute
In a novel experiment, moderate doses of carbon monoxide protected against the symptoms of multiple sclerosis in mice.
Researchers believe that the poisonous gas prevents the development of symptoms, such as paralysis, by stopping harmful molecules called free radicals from forming in the nervous symptom.
Miguel Soares at the Gulbenkian Science Institute in Oeiras, Portugal, and colleagues injected the animals with a protein mixture known to cause experimental autoimmune encephalomyelitis, a mouse model of multiple sclerosis (MS).
Ten days later some of the mice were placed in a chamber where they breathed carbon monoxide (CO) at a concentration of about 500 parts per million for 20 days. Soares notes that while the mice functioned normally at this level of CO exposure, a similar concentration of the gas can cause headaches and fainting in humans.
At the end of the trial, the mice that had breathed CO showed much greater mobility than their control counterparts. While the experimental mice had limp tails, the control mice suffered complete hind limb paralysis.
Free radicals
Soares suspects that CO works in this fashion because it promotes the binding of iron to heme molecules within the nervous system. Heme molecules that lack iron can increase the production of free radicals, which damage cells.
Immune cells produce free radicals in order to kill off bacteria. Soares suggests that disrupted immune cells in the nervous system of MS patients might overproduce free radicals, thereby causing the tissue damage that leads to paralysis. He believes that CO might work to counter this overproduction, thereby slowing the progression of disease.
Pharmaceutical companies are currently working on developing drugs that can deliver carbon monoxide locally within the nervous system, the researchers say. They stress that MS patients should under no circumstances try inhaling carbon monoxide – the gas can be lethal.
Journal reference: Journal of Clinical Investigation (DOI: 10.1172/JCI28844)
Norway May Ease Stem Cell Research Ban
By The Associated Press
Fri, Jan. 26 2007 10:13 AM ET
OSLO, Norway (AP) - Norway's government proposed lifting a national ban on using human embryonic stem cells for research, saying Friday that the change might help find cures to a broad range of diseases.
Embryonic stem cells have the ability to become any tissue in the body, leading scientists to see them as a possible source of medical breakthroughs. But the research typically involves the destruction of frozen embryos created for in vitro fertilization, a step that stirs passions over the beginning of life.
Norwegian biotechnology law from 2003 bars use of fertilized eggs or stem cells taken from them in research, and requires eggs left over after assisted pregnancies to be destroyed.
The proposed law would allow research on such eggs under strict legal and ethnical limits, including consent from the parents and approval from a national ethics panel, the government proposal said.
"The government believes it is important to use the opportunities offered by science to gain knowledge that can be used to treat serious illnesses in the future," Minister of Health and Care Services Silvia Brustad said in presenting the legislation.
"There is hope that stem cell research could contribute to finding treatments for Parkinson's disease, heart conditions, multiple sclerosis, diabetes, HIV/AIDS, cancer and other ailments," she said.
Brustad also said a new law would be more in line with those of other European nations.
The proposal would not allow scientists to fertilize eggs for use in research, but only eggs deemed as surplus because of poor quality, or because they have been stored in deep freezer for more than the allowable five years. It would also require the research to be completed within 14 days of fertilization or thawing stored eggs.
The bill would also ease restrictions on a fertility procedure called pre-implantation genetic diagnosis, or PGD _ used when parents want to avoid having a child with a lethal or severely debilitating birth defect. That is only allowed with special authorization from a government panel, generally for treatment in countries other than Norway.
The revision would allow a new board, handling only PGD-type cases, to decide whether the risk of a severe, hereditary ailment was great enough to warrant the treatment.
The three-party coalition government of Labor, the Center Party and the Socialist, has a majority of 87 seats in the 169-seat parliament, or two more votes than needed to pass legislation.
However, embryonic research is often hotly debated, with opponents arguing that it is wrong to sacrifice human life, even at the embryo stage, for research. It was not immediately clear whether any of the government's majority backing would object to the amendment.
Copyright © 2007 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.
Thursday, January 25, 2007
Antibodies to Myelin Don't Signal MS
By Neil Osterweil, Senior Associate Editor, MedPage Today
Reviewed by Rubeen K. Israni, M.D., Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine
January 24, 2007
BASEL, Switzerland, Jan. 24 -- Contrary to a previous report, the presence in the blood of two types of antibodies to myelin is not diagnostic of multiple sclerosis, investigators here reported.
Action Points
Explain to interested patients that the demyelinating disease multiple sclerosis is diagnosed according to clinical symptoms and MRI evidence of brain lesions. Contrary to findings of an earlier research group, this study suggests that the presence of antibodies to myelin are not diagnostic of MS or of MS risk.
Nor does the presence of the antibodies indicate a risk of progression to clinically definite MS, found Jens Kuhle, M.D., of University Hospital here, along with European and Canadian investigators.
Although other investigators have found that the patients with serum antibodies against myelin oligodendrocyte glycoprotein and myelin basic protein were at increased risk for MS, Dr. Kuhle and colleagues could find no such link, they reported in the Jan. 25 issue of the New England Journal of Medicine.
In a study of 462 patients with a first clinical event suggestive of MS and at least two silent brain lesions on MRI, there was no association between serum levels of either of two antimyelin antibody types and risk of progression to clinically definite MS.
"Our results strongly suggest that antimyelin antibodies have no role in the diagnosis of multiple sclerosis or in the identification of patients at high risk for the development of clinically definite disease," the investigators wrote. "Alternatively, there may be a role for such antibodies, but we may need more sophisticated methods to detect them."
The investigators used serum samples from the 462 patients enrolled in the BENEFIT study, a randomized double-blind, placebo-controlled, phase III trial evaluating Betaseron (interferon beta-1b) at a dose of 250 ฮผg subcutaneously every other day in patients with a first clinical episode suggestive of MS, and at least two clinically silent lesions detect on MRI scans of the brain.
They measured serum anti-myelin oligodendrocyte glycoprotein and anti-myelin basic protein at baseline by Western blot analysis, and compared the results with the time and rate of progression to clinically definite multiple sclerosis, or to a diagnosis of multiple sclerosis as defined by an international panel (the McDonald criteria).
The patients had regular visits for the assessment of neurologic impairment and for MRI before treatment and at months three, six, nine, 12, 18, and 24.
They used chi square analysis and the Kruskal-Wallis test to compare the baseline characteristics of the patients in the placebo and treatment groups according to antibody status.
They used Kaplan-Meier analysis to calculate cumulative risk of progression to clinically definite multiple sclerosis, or multiple sclerosis as defined by the McDonald criteria), and created Cox proportional-hazards models adjusted for potential confounding variables to assess whether antibody status predicted the development of MS.
They controlled for age, sex, use of corticosteroid treatment for the first event, the effect of treatment with Betaseron, multifocal or monofocal disease presentation, and the number of gadolinium-enhancing lesions on T1-weighted MRI scans and the number of hyperintense lesions on T2-weighted scans.
During the two-year study, 150 patients (32%) were diagnosed with clinically definite multiple sclerosis, and 331 (72%) were diagnosed with MS according to the McDonald criteria.
The authors found that "there was no increase in the risk of clinically definite multiple sclerosis or of multiple sclerosis according to the McDonald criteria among patients who were positive for anti-myelin oligodendrocyte glycoprotein antibodies, anti-myelin basic protein antibodies, or both," the authors wrote.
"This was true for both IgM and IgG antibodies not only in the total study population but also in all subgroups analyzed: patients receiving placebo or interferon beta-1b, patients with positive cerebrospinal fluid findings, patients who had received corticosteroid treatment, and patients with shorter or longer intervals between the initial clinical event and blood collection."
"Finally, we were unable to confirm the previously reported association between the number of lesions seen on gadolinium-enhanced MRI brain scans and the anti-myelin oligodendrocyte glycoprotein or anti-myelin basic protein antibody status," they added.
They noted that time of blood sample collection -- for example, within a few days of the first manifestation of clinical disease and before corticosteroids -- could have had an influence on the results.
They also acknowledged that the follow-up in the study, which was limited to two years, may have been too short to detect a positive correlation between the antibodies and MS.
"However, in view of the number of patients in whom clinically definite multiple sclerosis or multiple sclerosis according to the Mc-Donald criteria was diagnosed during the two-year follow-up period, a major change in the results with longer follow-up would be highly improbable, " they wrote.
The study was supported in part by Schering AG, which sponsored the BENEFIT study, and by a grant from the Swiss Multiple Sclerosis Society.
No potential conflicts of interest relevant to the study were reported by the authors.
Chromos Reports Preclinical Data in Support of CHR-1103 as an Acute Therapy for Relapse Associated with Multiple Sclerosis
Brain Pathology paper has implications for treatment of MS
BURNABY, BC, January 25, 2007 /PRNewswire-FirstCall/ - Chromos Molecular Systems Inc. ("Chromos") announced today the publication of a paper entitled "Modulation of Experimental Autoimmune Encephalomyelitis by VLA-2 Blockade" in the peer-reviewed scientific journal, Brain Pathology. This paper, authored in collaboration with Dr. Robert Fujinami of the University of Utah School of Medicine, demonstrates that a monoclonal antibody directed against VLA-2, the target for Chromos' lead product candidate CHR-1103, can suppress the clinical and pathological signs of disease in a relevant animal model of multiple sclerosis (MS). In addition, the publication validates VLA-2 as a potential target for early therapeutic intervention in the treatment of MS. This data represents a significant milestone in the development of CHR-1103 as an acute treatment for relapses associated with MS.
"We are very pleased with the release of this data as it represents the culmination of a tremendous body of work in support of the development of CHR-1103 as an acute treatment for MS relapse," said Alistair Duncan, President and CEO. "Currently, there are no FDA approved therapies for MS patients suffering from a relapse. CHR-1103 represents a promising new approach for the treatment of MS relapse and disease compared to the existing portfolio of chronically administered treatments."
CHR-1103 is a humanized monoclonal antibody being developed as a broad-based anti-inflammatory agent, with an initial focus on the treatment of acute relapses associated with MS. Unlike therapeutics designed to delay or antagonize the initial stages of inflammation, CHR-1103 is designed to reduce and prevent the accumulation of inflammatory cells within inflamed tissues. This distinction, i.e., the targeting of ongoing inflammation with CHR-1103, may provide a significant advantage for the acute treatment of inflammatory conditions and/or diseases.
Chromos completed its first meeting with officials from the U.S. Food and Drug Administration (FDA) for CHR-1103 in Q3 2006. The two parties discussed Chromos' clinical approach, proposed preclinical safety evaluation program and manufacture of CHR-1103. Chromos is now moving forward with preclinical safety evaluation studies in preparation for an Investigational New Drug (IND) application in Q4 2007.
About Chromos
Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The Company's lead program, CHR-1103, is a humanized monoclonal antibody being developed as a treatment with an initial focus on the treatment of acute relapses associated with multiple sclerosis (MS). Chromos generates revenue from its proprietary ACE System technology to engineer production quality cell lines to manufacture biopharmaceutical products including monoclonal antibodies. For more information visit our website at www.chromos.com.
Risks and Uncertainties
Certain of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Chromos (the "Company"), or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with the Company's operations. Operating risks include (i) the continued availability of capital to finance the Company's activities; (ii) the Company's limited cash position; (iii) the ability to successfully obtain proof of the effectiveness of the Company's technology; (iv) the ability to complete and maintain corporate alliances relating to the development and commercialization of the Company's technology; (v) the ability to obtain and enforce patent and other intellectual property protection for the Company's technology; (vi) market acceptance of the Company's technology; (vii) the competitive environment and impact of technological change; (viii) the Company's ability to attract and retain employees to carry out its business plans; (ix) the timely development and commercialization of any technology or products that are contingent on the completion and maintenance of corporate alliances with third parties and (x) regulatory approval for the conversion of the outstanding Notes. Further details on Chromos' operating risks can be found in the Company's Quarterly and Annual Reports to Shareholders.
CONTACT: Jeff Charpentier, Vice President, Finance and CFO, Tel: (604) 415-7132, , Website: www.chromos.com; To update your contact information or to be removed from this dissemination list, please e-mail Email:jcharpentier@chromos.com ir@chromos.com
Ticker Symbol: (Toronto:CHR.)
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St. Jude Researchers Find Novel Way to Regulate T Cells
Jan 25 2007, 12:14 PM EST
The immune system attack seems to be led by one of two specific enzymes chopping off a protein called LAG-3 from the immune cells, according to investigators at St. Jude Children's Research Hospital. They report that this is the first example of a protein, required for dampening T-cell activity, being controlled by getting chopped off at the T cell's surface.
The team demonstrated that LAG-3 is cleaved by two metalloprotease enzymes, called ADAM10 and ADAM17. The activity of these enzymes is controlled by distinct but overlapping signals generated from the T-cell receptor.
Certain drugs that inhibit metalloproteases now under development as treatments for multiple sclerosis and arthritis appear to work by keeping T cells on a tight leash, Dario Vignali, Ph.D., associate member of the St. Jude Department of Immunology notes.
This finding represents a new concept in how T cells are regulated, says Dr. Vignali, who is also senior author of the report published in the January 24 issue of The EMBO Journal. He believes the discovery could thus demonstrate an additional way in which these drugs work.
Wednesday, January 24, 2007
Merck Serono Has Initiated the ONWARD Study to Evaluate Oral Cladribine as Add-on Treatment for Multiple Sclerosis
ONWARD Phase II Trial Will Assess Therapeutic Benefit of Oral Cladribine Added-on to New Formulation of Rebif(R) in Multiple Sclerosis Patients
GENEVA, Switzerland, January 24, 2007 /PRNewswire-FirstCall/ -- Merck Serono announced today that it has begun the ONWARD (Oral Cladribine Added ON To Rebif New Formulation in Patients With Active Relapsing Disease) Phase II study. The ONWARD study will evaluate the safety, tolerability and efficacy of two dose regimens of Merck Serono's proprietary oral formulation of cladribine when added to the new formulation of Rebif(R) (interferon beta-1a) in multiple sclerosis (MS) patients with active disease despite treatment with Rebif(R). Oral cladribine is currently also evaluated as a monotherapy in a fully enrolled Phase III pivotal trial (the CLARITY study) for first-line treatment of relapsing forms of MS. The new formulation of Rebif(R) is under regulatory review by the European Medicines Agency, the US Food and Drug Administration and other healthcare authorities.
"Multiple sclerosis patients with signs of active disease while on treatment with a disease modifying drug may benefit from adding another agent with a different mechanism of action, to complement and increase the overall efficacy while maintaining an acceptable safety and tolerability profile," said Bruno Musch, Merck Serono's Head of Neurology Clinical Development. "The different mechanism of action and the oral intermittent administration of oral cladribine make it a potentially useful add-on therapy to Rebif(R) at a critical time of disease progression."
"Oral cladribine is currently being evaluated as a monotherapy in the CLARITY Phase III pivotal study and is on track to become the first oral therapy for first-line treatment of multiple sclerosis", said Franck Latrille, Merck Serono's Head of Product Development. "We are now initiating the ONWARD study as we believe that oral cladribine also has a great potential as an add-on therapy, for patients who have signs of active relapsing disease while on a treatment."
The ONWARD study is a two-year (96 weeks), randomized, double-blind, placebo-controlled, international trial. The trial will be conducted in 40 sites located in the United States and in Europe. It will involve 260 MS patients who have experienced at least one relapse while taking Rebif(R) during the year prior to study enrollment. Study participants will be randomized in one of the three arms of the study to receive one of two different dose regimens of oral cladribine or matching placebo tablets, in addition to the new formulation of Rebif(R) 44 micrograms subcutaneous three times a week. In the study, oral cladribine is given in two or four treatment cycles in the first year, with each cycle consisting of daily administration for four or five consecutive days, which means study patients take oral cladribine therapy for only 8 to 20 days during that year. In the second year, two treatment cycles are administered in all dose regimens.
The primary safety endpoints of the ONWARD study consist of a wide range of safety and tolerability parameters measured during 96 weeks of treatment. The primary efficacy endpoint is the mean change in the number of new T1 gadolinium-enhanced lesions per subject per magnetic resonance imaging (MRI) scan from baseline to 96 weeks.
About oral cladribine
Merck Serono's proprietary oral formulation of cladribine is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS. Through its differentiated mechanism of action, oral cladribine may offer a safe and effective new option to patients with MS.
About Rebif(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fight disease and reduce inflammation.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. In the United States, Rebif(R) is co-marketed by EMD Serono, Inc. (the US affiliate of Merck Serono) and Pfizer Inc. Rebif(R) has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area[1]. Rebif(R) is not approved for treatment of chronic progressive MS. Rebif(R) is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack, and can be stored at room temperature for up to 30 days if a refrigerator is not available.
Most commonly reported side effects are injection site disorders, flu-like symptoms, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif(R) with their doctors.
About Merck Serono and multiple sclerosis
Merck Serono is a leader in multiple sclerosis (MS) with Rebif(R) (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif(R), the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone(R) (mitoxantrone for injection concentrate) for worsening forms of MS. Full prescribing information for these products can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development including: osteopontin, an MMP-12 inhibitor, a JNK inhibitor and interferon beta:Fc. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS, with a whole genome scan currently underway.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. 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 Merck 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 Merck 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 Merck 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. Merck 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 Merck Serono
Merck Serono is a global biotechnology leader, with sales in over 90 countries. The Company is the world leader in reproductive health, with Gonal-f(R), Luveris(R) and Ovidrel(R)/Ovitrelle(R). It has strong market positions in neurology, with Rebif(R), as well as in metabolism and growth, with Saizen(R), Serostim(R) and Zorbtive(TM). The Company has recently entered the psoriasis area with Raptiva(R). Merck Serono's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology and autoimmune diseases.
Bearer shares of Merck Serono S.A., the holding company, are traded on the virt-x (SERO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
About Merck
Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by about 35,000 employees (including Merck Serono) in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73% interest and free shareholders own the remaining 27%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
[1] The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
CONTACT: Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland,www.merckserono.net, Corporate Media Relations, Tel:+41-22-414-36-00, MediaRelations, USA, Tel :+1-781-681-23-40, Corporate Investor Relations,Tel:+41-22-414-36-01, Investor Relations, USA, Tel:+1-781-681-25-52
Ticker Symbol: (NYSE:SRA)
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Tuesday, January 23, 2007
Artielle ImmunoTherapeutics, Inc., and QSV Biologics, Ltd. Sign Contract for cGMP Manufacture of RTL 1000 for Multiple Sclerosis
Announced today the signing of a contract for the process development and cGMP manufacturing of RTL 1000 for multiple sclerosis.
EDMONTON, Canada | Jan 22, 2007 | QSV Biologics, Ltd (QSV), a North American based biologics CMO located in Edmonton, Canada, and Artielle ImmunoTherapeutics, Inc., (Artielle) a privately held autoimmune therapeutics company located in Portland, Oregon, U.S.A., announced today the signing of a contract for the process development and cGMP manufacturing of RTL 1000 for multiple sclerosis. QSV will be responsible for technology transfer, process development and cGMP manufacture of phase II/III clinical trial material in their licensed cGMP manufacturing facility. RTL 1000, licensed by Artielle from Oregon Health & Science University, is a Recombinant T cell receptor Ligand (RTL) that can treat a wide range of autoimmune diseases.
Graeme Macaloney PhD, PEng, QSV President & CEO said: "The combination of novel class of molecules, experienced management team, and quality investors behind Artielle ensure the best possible opportunity for successfully bringing these much needed autoimmune disease therapies to patients. We are proud to be providing the manufacture of this important MS therapeutic."
Artielle ImmunoTherapeutics, Inc. (www.artielle.com), is a privately held autoimmune therapeutics company located in Portland, Oregon. Artielle's technology is focused on a new proprietary class of molecules known as Recombinant T cell receptor Ligands (RTLs) that can be tailored to treat a wide range of autoimmune diseases. Artielle has developed a lead compound for the treatment of multiple sclerosis, called RTL 1000, which is in Phase 1 clinical trials and has received Orphan Drug status from the U.S. Food and Drug Administration. In addition to multiple sclerosis, Artielle is conducting research on other autoimmune diseases to which its platform technology is also applicable, such as rheumatoid arthritis, celiac disease and uveitis.
QSV Biologics, Ltd. (www.qsvbiologics.com), is an international cGMP biologics contract manufacturer (CMO) providing microbial fermentation & cell culture, and purification services. QSV's facility has a 10 year track-record including an Establishment License for manufacturing clinical trial and commercial biologics. QSV was the sole recipient of the prestigious international Frost & Sullivan "Customer Value Enhancement Award" in 2005.
QSV's clientele span three continents and develop protein therapeutics, vaccines & diagnostics. As a dedicated CMO with no competing products of its own, QSV builds value for its clients by producing quality products in a timely manner. Hence its acronym: QSV: Quality & Speed build Value.
For further information: Richard Hetrick, Director of Business Development, QSV Biologics, Ltd., Ph: (780) 438-5722 Ext. 1, Email:
RHetrick@QSVBiologics.com; Gil Miller, Executive Vice President, Artielle ImmunoTherapeutics, Inc., Ph: (503) 626-1144, Email: gil.miller@artielle.com
SOURCE: Artielle ImmunoTherapeutics, Inc
Viragen Reports OVA™ System Milestone: Interferon Alpha Expressed in Eggs
PLANTATION, FLORIDA – January 23, 2007 – Viragen, Inc. (AMEX: “VRA”; “VRA.U”; “VRA.WS”) and its collaborative partners in the field of avian transgenics, Roslin Institute and Oxford BioMedica (LSE: “OXB”), today announced a new achievement with the successful expression of human interferon alpha-2a in the whites of eggs laid by transgenic hens using the OVA™ System (Avian Transgenic Biomanufacturing). This is the third therapeutic protein expressed thus far in a series of “proof-of-principle” studies, which aim to develop the OVA™ System as a novel, large-scale biomanufacturing alternative capable of cost-effectively expressing many types of therapeutic proteins. Viragen holds the worldwide exclusive license to commercialize Avian Transgenic Technology as granted by Roslin Institute.
Alpha interferon is a protein produced by the human immune system that is fundamental to the body’s resistance to disease. This OVA™-expression study produced interferon alpha-2a, which is the active ingredient in Roferon®-A* (Hoffman-LaRoche Inc.), a drug approved for the treatment of certain chronic infectious diseases and cancers. Importantly, the team has previously demonstrated that the OVA™ System can repeatedly target expression to the oviduct and incorporation in the egg, rather than being expressed throughout the bird, plus the characteristic of protein drug expression is able to be passed to subsequent generations. This combination of features is essential for a viable and cost-competitive manufacturing system.
Viragen has previously reported successful OVA™-expression of a humanized monoclonal antibody it is developing for advanced malignant melanoma and interferon beta-1a, which is currently marketed under two competing brand names for the treatment of Multiple Sclerosis (MS), as Avonex®** (Biogen Idec) and Rebif®*** (Serono).
The Project’s Scientific Leader, Dr. Helen Sang of Scotland’s Roslin Institute, commented, “With each new functional protein that we recover from transgenic hens’ eggs, synthesized as a component of the egg white, we significantly advance our collective knowledge and experience. We have now demonstrated synthesis of three different proteins at a consistent level and will move on to characterize OVA™-expressed interferon alpha to further refine and optimize the technology.”
According to Vice President and Managing Director of Viragen (Scotland) Ltd., Dr. Karen Jervis, the OVA™ System production method differs dramatically from standard interferon manufacturing methods. “Typically, single-subtype, recombinant alpha interferon is manufactured in bacterial or mammalian cells in bioreactors housed in complex and costly facilities. With the OVA™ System, we expect to offer large-scale manufacturing capabilities in a setting far less capital-intensive and with high levels of efficiency and quality. Most importantly, OVA™-expressed proteins will need to adhere to extremely stringent quality standards, and we are proceeding with comprehensive internal and external studies to fully characterize the proteins we express through biochemical and functional testing. These data, if positive, will be pivotal in preparing both a compelling economical model and a safety/quality case for the regulatory authorities.”
“I congratulate the Viragen, Roslin and Oxford BioMedica teams that all played key roles in adding another therapeutic candidate to our portfolio of OVA™-expressed proteins,” stated Viragen’s President and CEO, Charles A. Rice. “This alliance continues to pioneer advancements in the field of transgenic hen protein production, and as we gather additional supporting evidence, we will pursue strategies designed to expedite a regulatory pathway for one candidate, which we expect to ultimately lead to key commercial licenses.”
Viragen has no agreements with Hoffman-LaRoche, Biogen Idec or Serono and did not collaborate with these companies in connection in these avian expression studies.
* Roferon®-A (interferon alpha-2a) is a registered trademark of Hoffman-LaRoche Inc.
** Avonex® (interferon beta-1a) is a registered trademark of Biogen Idec, Inc.
*** Rebif® (interferon beta-1a) is a registered trademark of Serono, Inc.
About the OVA™ System:
Viragen holds the worldwide exclusive license to commercialize the OVA™ System (Avian Transgenic Biomanufacturing) as granted by the Roslin Institute (Scotland). The project is designed to develop the chicken into a pharmaceutical bioreactor, one that can meet the growing need for protein-based human therapeutics. Based on the creation of lines of transgenic hens which have been engineered to produce a target protein in their eggs using the LentiVector® gene delivery system licensed from Oxford BioMedica plc, this technology is being developed as an efficient and economical alternative to standard bio-manufacturing techniques, having many apparent advantages in ease of scale-up, lower costs of production and quality of product produced.
This project has been funded in part from a grant awarded by the Scottish Executive’s “SPUR Plus Program”, designed to support significant technological advances being made in Scotland.
About Viragen, Inc.:
With international operations in the U.S., Scotland and Sweden, we are a bio-pharmaceutical company engaged in the research, development, manufacture and commercialization of therapeutic proteins for the treatment of cancers and viral diseases. Our product and product candidate portfolio includes: Multiferon® (multi-subtype, human alpha interferon) which is uniquely positioned in valuable niche indications, such as high-risk malignant melanoma, other niche cancer indications and selected infectious diseases; VG101, a humanized monoclonal antibody that binds selectively to an antigen over-expressed on Stage IV malignant melanoma tumors; and VG102, a highly novel humanized monoclonal antibody that binds selectively to an antigen that is over-expressed on nearly all solid tumors. We are also pioneering the development of the OVA™ System (Avian Transgenics), with the renowned Roslin Institute, the creators of “Dolly the Sheep”, as a revolutionary manufacturing platform for the large-scale, efficient and economical production of human therapeutic proteins and antibodies, by expressing these products in the egg whites of transgenic hens.
Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
E-mail: dcalder@viragen.com
The foregoing press announcement contains forward-looking statements that can be identified by such terminology such as “believes,” “expects,” “potential,” “plans,” “suggests,” “may,” “should,” “could,” “intends,” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations regarding future research, development and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the success of third-party marketing efforts; our ability to retain third-party distributors; our ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as to the date they are made. The Company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.
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