Cannabis Based Medicine (Sativex®) Relieves Spasms And Stiffness In People With Multiple Sclerosis

Today, a leading neurology journal - European Journal of Neurology (EJN) reports a study1 which shows that Sativex, a cannabis based medicine, significantly reduces intractable spasms and stiffness (spasticity) in people with Multiple Sclerosis (MS).

Spasticity is one of the most common symptoms of MS, occurring in up to 84% of patients1. Spasticity can severely impact quality of life and is one of the most difficult symptoms of MS to treat1.

The study, a randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, saw Sativex or placebo added to existing anti-spasticity medication. Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05). Further, the addition of Sativex produced a more than 30% improvement in spasticity in 40% of the people treated1.

Fern Andrews, a person with MS who has participated in clinical trials with Sativex, commented: "Spasticity can make the simple daily activities that most people take for granted, seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support. With Sativex, I'm able to choose how much I take depending on how bad my symptoms are - which is a real benefit".

Christine Jones, Chief Executive of the MS Trust said, "Effective relief of spasticity is extremely important to people with MS. Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

About the study published in the European Journal of Neurology:

The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial1.

Sativex®:

Sativex (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.

Sativex has been developed by UK-based GW Pharmaceuticals plc. It is approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently being reviewed by European regulatory authorities for the symptomatic relief of spasticity in MS and, on approval, will be exclusively marketed by Bayer HealthCare in the UK.

Spasticity:

Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.

Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult. Pain can be associated with spasticity. Current treatments are often only partially helpful.

About Bayer HealthCare:

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division, Bayer Schering Pharma AG, comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases. http://www.bayerhealthcare.com

About GW Pharmaceuticals plc:

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.

GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. http://www.gwpharm.com

References:

1. Collin C et al. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology, March 07

JK Rowling Condemns MS Drug Ban Ahead of Holyrood Debate

EDINBURGH, Scotland, February 28 /PRNewswire/ -- JK Rowling, patron of the MS Society Scotland, has condemned a decision that denies people affected by aggressive multiple sclerosis (MS) access to a new drug on the NHS ahead of a debate in the Scottish Parliament on Thursday (1 March).

The Scottish Medicines Consortium (SMC) advised against the use of Tysabri - a drug for people affected by severe relapsing remitting multiple sclerosis (MS) - on economic grounds back in December.

Jo Rowling, patron of Scotland's largest MS charity, said: "I know from personal experience that MS can have a devastating effect on everyone that comes into contact with it. My mother suffered terribly with MS and it was so frustrating that there was little or nothing doctors could do to help her.

"If a drug can help tackle MS - particularly the very aggressive type of relapsing MS we are talking about - it should not be ruled out because of cost alone.

"Once again, decisions about treatment are being made by accountants rather than clinicians, and I hope MSPs will speak up on behalf of the thousands of families affected by MS across Scotland."

MS Society Scotland director Mark Hazelwood said: "Tysabri is an important treatment choice for the small number of people who suffer repeated, disabling relapses and who don't respond to current MS drugs.

"We at the MS Society believe people affected by MS in Scotland should have the same access to treatments as their counterparts do in Ireland, Germany, the USA and elsewhere. More than 10,000 people are now taking this drug worldwide, but we are barely out of the starting blocks.

"The Minister has indicated that he is not prepared to look again at the SMC's decision, but we very much hope the door is not closed."

Tricia Marwick MSP will be holding a briefing for media and MSPs at the Scottish Parliament today (28 February) in room P1.02 at 6pm, which Mark Hazelwood will attend with neurologist Belinda Weller and Fiona Burns, a person with MS. Thursday's member's debate takes place at 5pm.

Notes to Editors:

- The MS Society Scotland (http://www.mssocietyscotland.org.uk) is Scotland's largest charity dedicated to supporting everyone whose life is affected by MS.


- More than 10,000 people have MS in Scotland, with one in 500 people affected. This is the highest rate in the world.


- MS is the result of damage to myelin - the protective sheath surrounding nerve fibres of the central nervous system - which interferes with messages between the brain and the body.


- For some people, MS is characterised by periods of relapse and remission while for others it has a progressive pattern.

Distributed by PR Newswire on behalf of Multiple Sclerosis Society

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Botox 'major advance' in bringing bladder relief

28.02.2007

It has won an army of celebrity fans for banishing crow's feet and frown lines, but the use of Botox to combat bladder problems such as incontinence has been hailed as a 'major advance' by a urology expert.

Christopher Chapple, a visiting professor at Sheffield Hallam University, said poisonous botulinum toxin could be used therapeutically to treat bladder storage and sensation problems such as incontinence and cystitis. Professor Chapple, who is carrying out new research into the treatment at the University's Biomedical Research Centre, said it had successfully helped eighty per cent of cases during recent trials.

He explained in a lecture at Sheffield Hallam that a simple injection of the substance into the bladder lining could bring relief to some of the ten per cent of people in the UK who currently suffer from an overactive bladder, which is resistant to other drug therapy.

He said: "Doctors are now realising the role of the bladder lining as the cause of problems to do with frequent or painful passing of urine. By injecting the patient's bladder lining with botulinum toxin, we can block the release of nerve transmitter substances and sensory nerves, which means that the patient doesn't feel the need to go to the toilet as often. It also means we don't have to rely on intensive drug therapy, or invasive surgery.

"Around ten per cent of the current UK population has an overactive bladder, while nearly a third of us will experience bladder storage or sensation problems at some point in our lives.

"The bladder normally stores urine at a low pressure, until it can be passed at a socially acceptable time, but some people have problems storing urine and need to go frequently, and urgently. Problems can occur with age, or sometimes as the result of a neurological disorder such as multiple sclerosis.

"Imagine you've come home after a few drinks, you need to pee, and you're fumbling to get the key in the door - that's the sensation some of these people experience every day."

He added: "Treatment with botulinum toxin has been successful in eighty per cent of cases so far. Work is still ongoing, but there is no doubt that it is a major advance that will really improve sufferers' quality of life."

Botulinum toxin, commercially known as Botox, is highly toxic, but is used in minute doses to control muscle spasms. Demi Moore and Madonna have reportedly benefited from its cosmetic, wrinkle-softening effects.

The simple bladder lining treatment lasts between three and six months, and can be administered to outpatients under local anesthetic.

Around fifty people have currently been treated with the botulinum toxin treatment. Professor Chapple and his team are now involved in clinical trials, and will publish further findings at the end of the current, 18-month long research project.

Professor Chapple has a specialist interest in reconstructive surgery and is also working on engineering tissue to carry out urethral reconstruction. Other research is ongoing in the research group to investigate the underlying problems behind bladder and prostate problems.

Christopher Chapple is a Consultant Urological Surgeon at the Royal Hallamshire Hospital, part of Sheffield Teaching Hospitals NHS Trust.

He spoke at Sheffield Hallam University on Wednesday 21 February, 2007.
Kate Burlaga | Quelle: alphagalileo
Weitere Informationen: www.shu.ac.uk/news

Enabling nerve regeneration means evicting the cleanup crew

Cell Press

Macrophages are the immune cells that engulf and destroy the debris of damaged tissue to enable the healing process to begin. Their presence at the scene of damage is critical, but once their task is complete, it is just as critical that macrophages exit rapidly, ending the inflammatory process and making way for regrowth. In fact, the continued presence of macrophages could damage tissue, compromising repair.

While researchers know a great deal about the molecular machinery that launches this cellular cleanup crew into action, little has been known about the just-as-critical exit process.

Now, researchers have identified a key process by which macrophages are cleared from sites of peripheral nerve injury. The scientists say their findings could also have implications for understanding the same fundamental mechanism in spinal cord injury, stroke and multiple sclerosis.

Samuel David and colleagues published their findings in the March 1, 2007 issue of the journal Neuron, published by Cell Press.

The researchers concentrated on a family of cell receptors known as Nogo receptors, already known to be present on nerve cells and to play a role in nerve growth. Specifically, David and colleagues explored the role of one such Nogo receptor, NgR1. Receptors such as NgR1 are protein switches that nestle in the membranes of cells, and which induce a cellular response when triggered by a specific chemical signal, or ligand.

In the researchers' experiments, they induced damage in the sciatic nerve in the thigh of rats and mice and analyzed the role of NgR1 in the repair process.

They found that macrophages showed the presence of NgR1 on their surface once they arrive at the injury site and began their cleanup. Further experiments revealed that as the healing nerve began to form the protein myelin—the insulating sheath around nerves—this receptor not only caused a reduction in the macrophages' binding to myelin, but also an outright repulsion from the forming myelin. In fact, when the researchers created nerve injury such that new myelin would not be formed, the macrophages continued to lurk around the injury site. The researchers' experiments also identified specific molecules on myelin that triggered such repulsion.

The findings could also apply to nerves other than peripheral nerves, because macrophages activated during stroke, multiple sclerosis injury, and spinal cord injury also express NgR1 on their surface, pointed out the researchers.

"Our discovery of this novel (to our knowledge) role for NgRs in mediating the efflux of macrophages from inflamed neural tissue via interactions with myelin could therefore have broader implications for the regulation of inflammatory responses not only in other peripheral nerve pathologies, but also in [central nervous system] inflammation such as in spinal cord injuries, stroke, and multiple sclerosis," they concluded.

###
The researchers include Elizabeth J. Fry and Samuel David of The McGill University Health Center in Montreal, Quebec, Canada; Carole Ho of Stanford University Medical Center in Stanford, CA and Genentech Inc. in South San Francisco, CA.

This work was supported by a grant from the Canadian Institutes of Health Research to S.D. E.J.F. was supported by a Multiple Sclerosis Society of Canada post-doctoral fellowship and an award from the McGill University Health Center and Department of Medicine. C.H. was supported by an NINDS KO8 Career Development NS048058 Award.

Fry et al.: "A Role for Nogo Receptor in Macrophage Clearance from Injured Peripheral Nerve." Publishing in Neuron 53, 649–662, March 1, 2007. DOI 10.1016/j.neuron.2007.02.009. www.neuron.org.

Contact: Erin Doonan
edoonan@cell.com
617-397-2802

Accentia Biopharmaceuticals Acquires Worldwide Exclusive License to Revimmune for All Autoimmune Diseases

Revimmune uses an approved drug in a new patent-pending method to eliminate autoimmunity: In clinical studies for the lead indication of multiple sclerosis (MS), Revimmune improves function in most patients and stops progression in over 90% of cases refractory to standard therapies

Licensed technology applicable to 80 autoimmune diseases: long-term follow-up in severe, refractory, life-threatening autoimmune aplastic anemia demonstrates 70% of patients maintain complete remissions

TAMPA, Fla.--(BUSINESS WIRE)--Feb. 28, 2007--Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) has acquired the exclusive worldwide rights for Revimmune(TM), a patent-pending pharmaceutical treatment in late-stage development for a variety of autoimmune diseases. The in-license advances the Company's strategy of acquiring late stage drug candidates that can benefit from the 505(b)(2) regulatory pathway. Revimmune uses an ultra-high intensity, short-course of an intravenous formulation of an approved drug (cyclophosphamide), in a new patent-pending method to "reboot" a patient's immune system, thereby eliminating the autoimmunity, whereas current therapies including oral cyclophosphamide are used chronically to try to suppress the inflammation of autoimmunity. Based on long-term follow-up showing complete remissions, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases such as aplastic anemia and myasthenia gravis. Accentia's lead indication for Revimmune is multiple sclerosis (MS).

The Principal Investigator for the ongoing MS study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, Associate Professor of Neurology. Dr. Kerr stated: "Based on follow-up of up to 2 years, most people have a substantial improvement and many have a complete elimination of disease activity." The co-Principal Investigators on this study are Dr. Daniel Drachman and Dr. Robert Brodsky.

The Revimmune license covers all of the estimated 80 autoimmune diseases that are currently recognized. These include multiple sclerosis, systemic lupus, juvenile diabetes mellitus, rheumatoid arthritis, Crohn's disease, myasthenia gravis, and scleroderma. To date, over 175 patients, mostly those with severe refractory autoimmune diseases, have been treated with Revimmune. The Company believes that Revimmune is a "platform" technology that can be used in any autoimmune disease.

Revimmune can be administered as an inpatient or outpatient infusion for 4 hours per day for 4 consecutive days. Patients can recover at home while their immune system reconstitutes itself over a 2 to 3 week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune works by temporarily eliminating peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing the stem cells in the bone marrow. Investigators at Hopkins discovered that stem cells uniquely have high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to the new immune system over 2 to 3 weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

"Revimmune complements our strategy of developing late-stage, "disruptive" clinical products based on already approved active pharmaceutical ingredients. This product strategy is the basis of our lead product, SinuNase(TM), in which the active pharmaceutical ingredient is the approved antifungal, amphotericin B, and which we were able to advance directly into a Fast Tracked Phase 3 clinical trial for chronic sinusitis," said Dr. Frank E. O'Donnell, Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "Revimmune offers the hope of sustained remissions and cures for autoimmune diseases such as MS, thereby eliminating, or reducing dependence on chronic immunosuppressive therapies, which we believe are more toxic, carcinogenic, inadequate, inconvenient, and very expensive, especially in the case of monoclonal antibodies. Revimmune's use would also obviate the risk and expense of allogeneic (donor) stem cell transplantation to treat severe cases of autoimmune diseases. After consultation with the FDA, Accentia is preparing an IND for severe refractory multiple sclerosis and is proposing to enter Phase 3 clinical trials to support licensure under the 505(b)(2) regulatory pathway, which is an abbreviated regulatory process available when dealing with approved active pharmaceutical ingredients. The IND incorporates a novel risk management program to ensure appropriate patient selection, supportive care, and tracking of outcomes, which we believe will be critical to reimbursement coverage and malpractice protection for healthcare providers."

The technology is being licensed from Revimmune, LLC, a Hopkins Capital Group II LLC (HCG II) portfolio company, which holds the exclusive license for the technology from the Johns Hopkins University. HCG II had been exploring a license to the technology since 2003. Dr. Frank E. O'Donnell Jr. is a managing partner of HCG II. More details of the license can be found in the Company's 8-K filing. HCG II is not affiliated with The Johns Hopkins University.

BACKGROUND ON REVIMMUNE

Studies at Johns Hopkins University School of Medicine by Dr. Jones, Dr. Brodsky, and colleagues have demonstrated the potential benefits of Revimmune in a variety of autoimmune diseases.

According to information from the National Multiple Sclerosis Society (http://nationalmssociety.org/), there are approximately 400,000 people in the US with Multiple Sclerosis. For the clinical course, 85% of patients are in the category of relapsing-remitting. Based upon a paper by D. Hirtz et al.(1), "How common are the 'common' neurologic disorders?," the annual incidence of Multiple Sclerosis in the U.S. was approximately 4.2 new cases per 100,000 population in 2005.

Multiple Sclerosis:

Revimmune treatment of 20 Multiple Sclerosis patients has resulted in the following successful outcomes in 2 published studies from C. Krishnan, D. Kerr et al.(2) and D. Gladstone et al.(3):

All patients have had a reduction or elimination of new and enhancing lesions on the MRI


No patient has had a clinical exacerbation following treatment and most patients have had a reduction in EDSS and an improvement in the MSFC following treatment


During follow-up, no patients increased their baseline EDSS scores by more than 1.0


No patient had a new lesion on brain magnetic resonance imaging; no patient showed any enhancing lesions
Systemic Lupus:

Investigators have treated 40 severe systemic lupus erythematosus (SLE) patients in clinical studies with Revimmune. A significant improvement in the SLE diseases activity index was observed. There were 5 durable complete responses. Among severe, refractory cases, approximately 80% of patients treated had a complete or partial response when treated.

Myasthenia Gravis:

Using Revimmune, investigators have treated 11 patients with myasthenia gravis refractory to conventional immunosuppressive therapy. Nine of the subjects in the study markedly improved, and have returned to full activity.

Aplastic Anemia:

Acquired severe aplastic anemia (SAA) is a severe, life-threatening autoimmune disease wherein a patients' immune system mistakenly attacks their own stem cells in their bone marrow. Most SAA patients will die within a year of diagnosis. Investigators have treated 75 SAA patients with Revimmune and the majority of patients have achieved a complete remission without the need of other immunosuppressive agents.

Autoimmune Hemolytic Anemia:

Investigators have treated 10 patients with refractory autoimmune hemolytic anemia. After Revimmune treatment, all patients responded and became transfusion independent. There were 6 patients that achieved complete remission and 3 patients that achieved partial remission. There were no relapses at a median follow-up of 15 months and 7 of the 9 patients were able to discontinue steroids.

Experience with other autoimmune diseases:

Investigators have reported favorable case experience with refractory scleroderma, acquired pemphigus, rheumatoid arthritis, and Crohn's Disease.

References:

(1)"How common are the 'common' neurologic disorders?;" D. Hirtz, D. J. Thurman, K. Gwinn-Hardy, M. Mohamed, A. R. Chaudhuri, and R. Zalutsky; Neurology 2007 68: 326-337.

(2)"High-Dose Cyclophosphamide in the Treatment of Aggressive Multiple Sclerosis;" Chitra Krishnan, Daniel Drachman, Justin McArthur, David Irani, Avindra Nath, Carlos Pardo-Villamizar, David Yousem, Robert Brodsky, Peter Calabresi, Douglas A. Kerr, Baltimore, MD. AAN Abstract (P01.072); April 4, 2006.

(3)"High-Dose Cyclophosphamide for Moderate to Severe Refractory Multiple Sclerosis;" Douglas E. Gladstone, MD; Kenneth W. Zamkoff, MD; Lauren Krupp, MD; Robert Peyster, MD; Patrick Sibony, MD; Christopher Christodoulou, PhD; Emily Locher, RN; Patricia K. Coyle, MD Arch Neurol/Vol 63, Published Online August 14, 2006.

About Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development of late-stage "disruptive" clinical products, especially for already-approved drugs in new formulations and/or new indications that are patent-protected and which represent new therapeutics with greater clinical and economic value. Accentia has a pipeline of products in late-stage clinical development. The company's lead respiratory product candidate is SinuNase(TM), which is under clinical development to treat chronic sinusitis (rhinosinusitis). SinuNase is a novel application and formulation of a known anti-fungal exclusively licensed from the Mayo Foundation for Medical Education and Research. The product has been Fast Tracked by the FDA and the Company has commenced a Phase 3 clinical trial. The Company's other lead product is BiovaxID(TM), a patient-specific anti-cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary, Biovest International, Inc., (OTCBB: BVTI), is currently in a Fast-Tracked Phase 3 clinical trial. For further information, please visit www.accentia.net.

About Hopkins Capital Group, LLC

The Hopkins Capital Group II, LLC (HCG II) provides key funding for "disruptive technologies" in healthcare, and has invested in companies such as Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI), BioDelivery Sciences International, Inc. (NASDAQ: BDSI), RetinaPharma Inc., and CompuPen Inc. HCG II is not affiliated with The Johns Hopkins University. The managing partner of HCG II is Frank E. O'Donnell, Jr., MD. For further information, please visit www.hopkinscap.com.

Forward-Looking Statements

Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about SinuNase, BiovaxID, AutovaxID, Revimmune and any other statements relating to products, product candidates, product development programs the FDA or clinical trial process including the commencement, process or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACT: Revimmune and Patient Inquiries:
Accentia Biopharmaceuticals, Inc., Tampa, FL
Susan Bonitz, PhD
813-864-2554 - Extension: 277
sbonitz@accentia.net
or
The Investor Relations Group, New York
Investors:
Adam Holdsworth
212-825-3210
aholdsworth@investorrelationsgroup.com
or
Media:
Janet Vasquez or Lynn Granito
212-825-3210
jvasqyez@investorrelationsgroup.com
lgranito@investorrelationsgroup.com

SOURCE: Accentia Biopharmaceuticals, Inc.

VACCINEX ANNOUNCES ANTIBODY DEVELOPMENT AND COMMERCIALIZATION ALLIANCE IN MULTIPLE SCLEROSIS AND ONCOLOGY

Rochester, NY - Vaccinex, Inc. announced today that it has entered into a collaboration with Teva Pharmaceutical Industries Ltd. (NASDAQ: Teva) to develop and commercialize VX15, a novel human antibody discovered by Vaccinex. VX15 represents a new targeted therapy that has the potential to improve efficacy in treating Multiple Sclerosis (MS) by both suppressing the body's autoimmune response and blocking damage to the central nervous system. VX15 has also shown the ability to eradicate tumors in animal studies by inhibiting blood flow and starving cancer cells of nutrients and energy. VX15 is one of four Vaccinex antibodies currently in pre-clinical development.

According to the terms of the agreement, Teva will make an equity investment in Vaccinex and pay undisclosed fees, development milestones and royalties on product sales to acquire an exclusive license for the development and commercialization of VX15 in multiple sclerosis and other disease indications. Vaccinex retains rights to oncology indications and will continue to conduct all pre-clinical development activities which will be funded by Teva. Teva will have an option to participate as a co-development partner in oncology after Vaccinex completes Phase I clinical trials.

Teva and existing Vaccinex investor, Pan Atlantic Bank and Trust Limited, are participating as lead investors in Vaccinex's third major financing round, which the company anticipates will exceed $25 million.


"This transaction demonstrates Vaccinex's evolution from an antibody discovery company to a product-based company with a growing pipeline and increasing product development capabilities," said Dr. Maurice Zauderer, Vaccinex's President and CEO. "Teva is a tremendously valuable partner for VX15 due to its broad expertise and leadership in the MS market. We are pleased Teva has recognized that Vaccinex is uniquely poised to be a major player in the antibody market."

Vaccinex, Inc.

Vaccinex is a privately held biotechnology company engaged in the discovery and development of novel therapeutic antibodies. Utilizing its proprietary ActivMAb® technology, Vaccinex can select fully human monoclonal antibodies against targets that would be difficult to address with other technologies. This technology can also be used to fully humanize mouse and other non-human antibodies. The firm is headquartered in Rochester, NY and currently has 48 employees. (Also see the company's website, www.vaccinex.com).

Contacts

Vaccinex: Raymond E. Watkins, Vice President of Operations, 585.271.2700 (x-105)
e-mail: rwatkins@vaccinex.com

Suda Communications: Paul Kidwell, 617.296.3854
e-mail: paulkidwell@comcast.net

Initial Analysis of the Full Study Cohort Showed Treatment Did Not Demonstrate Significant Effect on Primary Endpoint of Accumulated Delay to Disabili

KANSAS CITY, Mo.--(BUSINESS WIRE)--Feb. 27, 2007--Data from the full cohort of the PROMiSE study showed that treatment with COPAXONE(R) (glatiramer acetate injection) did not reach a significant effect on the primary endpoint of accumulated delay to disability versus placebo in the entire population of patients with primary progressive multiple sclerosis (PPMS) (39.6 percent versus 45.2 percent respectively, p = 0.1753). However, post-hoc analyses demonstrated that COPAXONE(R) significantly delayed time to progression of accumulated disability in male patients in the study (n=455) who received treatment versus those who received placebo (p = 0.0193). Results of the randomized, double-blind study of over 900 patients were published in a recent issue of Annals of Neurology.

In the study, treatment differences in male patients emerged early and were maintained over time; 61.6 percent of male patients receiving COPAXONE(R) remained progression-free as opposed to only 49.1 percent of those in the placebo group. Data from the entire population also showed that COPAXONE(R) reduced the burden and activity of lesions in the brain as measured by T2-weighted and gadolinium (Gd)-enhanced magnetic resonance images (MRI).

"COPAXONE(R) in this trial demonstrated a trend towards slowed disease progression versus those patients left untreated, which was only statistically significant in male patients in the post hoc analysis," said Dr. Jerry Wolinsky, Bartels Family and Opal C. Rankin Professor of Neurology, interim Dean, The University of Texas Health Center at Houston and the lead investigator of the trial.

PPMS is a degenerative form of multiple sclerosis (MS), a chronic, progressive, degenerative disorder that affects nerve fibers in the brain and spinal cord. PPMS patients experience near continual progression of disease over their lifetimes without any discernable relapses or remission of neurologic disability. Compared with relapsing-remitting multiple sclerosis (RRMS) patients, PPMS affects a higher proportion of men than women, and data suggest that men with PPMS may progress faster than women. Currently, there are no proven effective treatments for PPMS.

"The results of the PROMiSe study may warrant additional trials surrounding the effect of COPAXONE(R) on PPMS, given the fact that there are no other treatments currently available. The lack of a statistically significant treatment response in women in the study does not mean that COPAXONE(R) doesn't hold promise for further study in this population," said Wolinsky.

About the Study

The PROMiSe trial followed 943 patients who were randomized for treatment with COPAXONE(R) (n=627) or placebo (n=316) in a two-to-one ratio. A pre-planned interim analysis of 935 patients, of whom 757 had completed at least two years or had terminated the study early, projected that no significant treatment effect could be reached for the primary endpoint, which was time to progression of Expanded Disability Status Scale (EDSS) scores (defined as change of 1.0 EDSS point or greater for entry EDSS of 3.0 - 5.0, or 0.5 for entry EDSS of 5.5 - 6.5). As a result, the study was terminated prematurely and study medication was discontinued.

Despite the termination of the PROMiSe study, patients were offered the opportunity to continue to be followed. An intent-to-treat (ITT) analysis at three years was conducted to determine whether different outcomes occurred in subgroups of patients because of an unexpected on-trial slow rate of disease progression among participants and abbreviated exposure to COPAXONE(R) (glatiramer acetate injection) therapy, both of which made detecting a treatment effect challenging. The post-hoc analysis demonstrated a trend toward delaying disease progression which was significant in the male subgroup of patients (n=455) who experienced a slowing disease progression to sustained disability in favor of COPAXONE(R). Post-hoc analyses are intended to re-examine an existing data set to determine potential patterns or trends that may not have been apparent based on the initial review of the data as set forth by the study design. The Kaplan Meier survival curve indicated delayed disease progression for males assigned to COPAXONE(R) diverged from a placebo-assigned patient curve within a year of study entry, and the gap widened over time.

"Currently there have been no clinical trials in PPMS as large or comprehensive as the PROMiSe trial, nor are there any comparable sized studies currently being undertaken," said Wolinsky. "Because of this trial, we probably know more about the natural history of PPMS than we did before, which is of immeasurable value to the field."

Initial data from the PROMiSE trial were previously reported at the 2004 Annual Meeting of the American Academy of Neurology.

About COPAXONE(R)

Current data suggests COPAXONE(R) (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE(R) is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE(R) are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE(R) is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd (NASDAQ:TEVA). COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic product, Teva's ability to generate revenues and profits closely tied to our success in obtaining U.S. market exclusivity for generic products, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra(R), Neurontin(R) and Wellbutrin XL(R) , the effects of competition on our innovative products, especially Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims which are not covered by insurance, dependence on effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, the difficulty of complex manufacturing of our products and supply delays, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


This is a news service of Thomson Business Intelligence Service ©2006. This content is for your personal use only, subject to Terms and Conditions. No redistribution allowed.

BioMS Medical Initiates Follow-On Open-Label MAESTRO-02 Multiple Sclerosis Trial Of MBP8298

BioMS Medical Initiates Follow-On Open-Label MAESTRO-02 Multiple Sclerosis Trial Of MBP8298


EDMONTON, Alberta, Feb. 27, 2007 - BioMS Medical Corp (TSX: MS), a leading developer of products for the treatment of multiple sclerosis (MS), today announced that it has initiated MAESTRO-02, the open-label follow-on portion to its MAESTRO-01 pivotal phase II/III clinical trial of MBP8298 for the treatment of secondary progressive MS.


Eligible patients who have successfully completed the blinded, placebo controlled MAESTRO-01 trial, may choose to receive MBP8298 on an un-blinded basis in MAESTRO-02 regardless of whether they were previously on placebo or drug. The trial will primarily evaluate the long-term safety of MBP8298.

“Now that the first patients who participated in our MAESTRO-01 pivotal trial have completed the study, we are pleased to offer MBP8298 on an open-label basis,” said Kevin Giese, President and CEO of BioMS Medical. “We believe MBP8298 has the potential to become the only safe and effective first line therapy for the treatment of secondary progressive MS. While MAESTRO-01 was designed to evaluate the safety and efficacy of MBP8298, MAESTRO-02 will provide additional important long-term safety and efficacy data to support regulatory submissions.”

About late-stage clinical trials for MBP8298:

BioMS recently announced that patient recruitment has been completed in the MAESTRO-01 trial. This trial includes approximately 550 patients at 48 trial sites in 10 countries. The Company remains on track to receive interim data in mid-2008.

Patients are being administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

MBP8298 is being studied in two additional late-stage clinical trials:

MAESTRO-03: A pivotal phase III U.S. trial of similar design to MAESTRO-01, evaluating MBP8298 for the treatment of secondary progressive MS. The trial is a randomized, double-blind study enrolling approximately 510 patients that will be initiated in 2007.

MINDSET-01: A phase II trial evaluating MBP8298 for the treatment of relapsing remitting multiple sclerosis (RRMS). The trial is a randomized, double-blind study enrolling up to 215 patients

About MBP8298 - Novel Mechanism of Action

In MS patients, the body’s immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve’s Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the I.V. injection of MBP8298 every six months.

Phase II and long-term follow-up treatment of MS patients with MBP8298, recently published in the European Journal of Neurology showed that MBP8298 safely delayed the median time to disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes.


BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and it has two pivotal phase III clinical trials for SPMS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States . It additionally has a Phase II MINDSET-01 trial in Europe for RRMS patients. For further information please visit our website at www.biomsmedical.com .

Neurological disorders affect 1 billion people -WHO

Tue 27 Feb 2007 11:21 AM ET

By Stephanie Nebehay

GENEVA, Feb 27 (Reuters) - Neurological disorders ranging from migraines to epilepsy and dementia affect up to 1 billion people worldwide and the toll will rise as populations age, the World Health Organisation (WHO) said on Tuesday.

The number of people suffering from Alzheimer's and other debilitating dementias, currently 24.3 million people, is expected to double every 20 years, with prevalence levels rising in developing countries, it said.

In a report entitled "Neurological Disorders: Public Health Challenges", the U.N. agency said that neurological care should become part of basic health care so that underdetected disabilities were diagnosed and treated, especially in Africa.

"Unless immediate action is taken globally, the neurological burden is expected to become an even more serious and unmanageable threat to public health," the WHO said.

Neurological disorders -- which also include strokes, multiple sclerosis, Parkinson's disease and brain injuries -- kill an estimated 6.8 million people each year, accounting for 12 percent of global deaths, it said.

"The burden of neurological disorders is reaching a significant proportion in countries with a growing percentage of the population over 65-years-old," Nobel medicine laureate Rita Levi-Montalcini said in a foreword to the report.



DOUBLING OF DEMENTIA RATES

Only 2 percent of dementia cases start before the age of 65, but for every 5 years people live over the age of 65, the prevalence of dementia roughly doubles, the report said.

"In developing countries, as life expectancy increases, people reach the age of dementia as well, which was not the case 20 years ago," Jose Manoel Bertolote, coordinator of WHO's unit for management of mental and brain disorders, told Reuters.

Yet weak health care systems, lack of trained personnel and essential drugs, and traditional beliefs which stigmatise many illnesses are deepening the treatment divide between rich and poorer nations, the WHO said.

Dementia, usually a progressive disease, leads to memory loss and other cognitive impairments. Neurological disorders can also cause paralysis, behavioural problems such as uncontrolled anger, or speech problems.

Some 50 million people worldwide suffer from epilepsy, most of them in developing countries, but an overwhelming majority of patients do not receive drugs to halt the seizures, it said.

"Despite the fact that highly effective, low-cost treatments are available, as many as nine out of 10 people suffering from epilepsy in Africa go untreated," said WHO Director-General Margaret Chan.

The report added: "In some African countries, people believe that saliva can spread epilepsy or that the 'epileptic spirit' can be transferred to anyone who witnesses a seizure. These misconceptions cause people to retreat in fear from someone having a seizure, leaving that person unprotected."

© Reuters 2007. All Rights Reserved.

Generic biotechs may be on way

Lawmakers seek to force FDA to set up approval system

By Bruce Japsen
Tribune staff reporter
Published February 25, 2007

Drugs derived from living cells, hailed for saving lives but known for their huge costs, could face generic competition under legislation gaining momentum in the newly emboldened Democratic-controlled Congress.

Many of the biotechnology drugs, first created in the 1980s when technology cleared the way for genetic engineering on DNA, are only now beginning to face patent expirations.

But the U.S. Food and Drug Administration is currently not prepared to approve generic versions of these or other expensive biotechnology-derived medicines because there is no regulatory pathway to bring what the industry calls "biogenerics" or "biosimilars" to market.

The 1984 Hatch-Waxman law that established the structure to win FDA approval of generic drugs is based largely on products derived from chemicals, such as the antidepressant Prozac or the popular cholesterol pill Zocor. Both were once blockbusters for the companies that developed them. Generic versions of drugs are now saving patients and taxpayers $10 billion a year, according to congressional estimates.

And opening the door to generic biotech drugs would save even more. Some of the drugs, like the anti-anemia drug Epogen, can cost more than $10,000 a year per patient. Other biotech treatments for cancer, multiple sclerosis and rheumatoid arthritis can cost even more.

"What many don't realize is that there is still no competition for one of the fastest growing and most expensive categories of drugs: so-called biotech drugs," said Rep. Henry Waxman, an influential California Democrat who is pushing generics legislation designed to bring cheaper biotech drugs to market.

Epogen alone cost the Centers for Medicare & Medicaid Services about $2 billion in its 2005 fiscal year, making it one of the federal government's most expensive outlays for a pharmaceutical, government records show.

If an approval process is established, tens of thousands of kidney dialysis patients, their employers and taxpayers may be in position to get a price break on Epogen in about four years. That's when California-based biotech company Amgen Inc., which launched the expensive product in 1989, will begin losing patent protection for the drug, which it calls one of the world's "first biologically derived human therapeutics."

"The biotech drugs really were not on the radar when Hatch-Waxman was approved," said Theresa Gerrard, a former FDA official who is now a regulatory consultant to drugmakers. "These biotech drugs are not as rare as they once were. They are mainstream medicines."

The prospect of making a cheaper version of Epogen might normally have the generic drug industry salivating at the idea of providing consumers with a cheaper alternative for an array of medicines for treating everything from cancer to multiple sclerosis.

Even if they sell it for half of what Amgen does, generics-makers would reap large revenues and U.S. consumers would potentially save hundreds of millions of dollars annually.

Generic biotech medicines could save health plans and patients more than $70 billion over 10 years, according to a recent study published by Express Scripts, a pharmacy benefit firm that is pushing for legislation that would require the FDA to establish guidelines for testing and approving generic biotech drugs.

The existing process to approve chemically derived generics, which is streamlined from the process used to approve the initial brand name drug, does not require clinical trials that involve testing in patients, and the application process takes only a few months.

Bills gaining momentum in Congress would create a streamlined path for generic biotech medicines that its supporters say would make drugs derived from living sources more affordable.

One of the bills has bipartisan support from Sens. Hillary Rodham Clinton (D-N.Y.) and Susan Collins (R-Maine). In the House, Rep. Rahm Emanuel (D-Ill.) and Rep. Jo Ann Emerson (R-Mo.) are among those leading the charge for the bill. A bill was introduced by Democrats in the House last fall but died under Republican control of Congress.

"These drugs are often life-saving," said Waxman, whose name is on the landmark 1984 generic drug bill that he co-authored with Republican Sen. Orrin Hatch of Utah. "Unfortunately, they also frequently cost tens of thousands of dollars per year, even hundreds of thousands. And there is no pathway for approving low-cost competing versions of these drugs, even after patents have expired."

The biotechnology industry is fighting the bill, saying their drugs are made in a more complex manner and therefore need more rigorous scrutiny and testing.

Brand name biotech companies say their medicines are derived from humans, animals and other natural sources and are not as simple to make as drugs made from chemicals that speed through an abbreviated application process.

"The legislative discussion on biosimilars must be focused on patient safety, based on sound science including clinical evidence, and consider input provided by scientists, physicians, patients, academia and the industry as part of a transparent process," said Amgen spokeswoman Kelley Davenport, adding that ongoing innovation will likely make generics outdated anyway.

The most likely process to get approved, according to industry analysts, will be modeled, in part, on regulations in Europe that make generic companies test biotech drugs.

Testing of generic biotech drugs in Europe can last five years but varies from drug to drug, companies working through the European process say. By comparison, it can take brand name companies several times that amount of time to develop just one drug at costs of hundreds of millions of dollars.

Lake Forest-based Hospira Inc. is working with a German-based drugmaker, Stada Arzneimittel AG, to bring a generic version of Epogen to market and is hoping to get an approval in Europe by the end of this year.

"Without a pathway established in the U.S. for the FDA to approve generic biologics, patients will not be able to get access to affordable alternatives to proprietary biologics," said Tom Moore, Hospira's president of global pharmaceuticals.

"If the Amgens and other [biotech companies] were indeed the only people who could produce these drugs, then why did they invest in these elaborate patent estates in the first place," Moore said.

Drugmakers like Hospira are confident that Congress will eventually approve a law creating a pathway for generic biotech drugs to win approval, possibly this year. With that in mind Hospira has begun early development of a generic Epogen for the U.S. market.

It plans to test its generic version of Epogen in its laboratories and in patients so that its testing will be completed in time to submit an application for FDA approval once Amgen patents begin to expire, assuming Congress has passed a law.

Hospira said it is investing undisclosed amounts of money preparing for biotech drugs to come off patent. It would not say what it planned to charge for a generic of Epogen.

"Despite the fact that there is no generic regulatory pathway we have come to the conclusion that it is inevitable," Moore said. "We would not be doing this unless we could not bring value in the marketplace for the patient."

Other companies, too, that have an expertise in either injectable pharmaceuticals or generics are expected to look at the generic biotech business. These include Teva Pharmaceutical Industries and Barr Pharmaceuticals Inc., industry reports say.

----------

bjapsen@tribune.com


Copyright © 2007, Chicago Tribune

New Fellowship To Study Multiple Sclerosis, University Of Queensland, Australia

The University of Queensland today announced the launch of a new fund to improve understanding of, and work towards a cure for, multiple sclerosis.

UQ Vice-Chancellor Professor John Hay, AC, announced that the University would contribute $25,000 towards a fund to establish a Multiple Sclerosis Senior Research Fellowship to be based at the University's Queensland Brain Institute.

"I hope the University's initiative will encourage private and corporate donors to come forward to support this project," Professor Hay said.

"We hope to raise a total amount of $450,000 to secure this fellowship, which will undertake important new research in multiple sclerosis (MS).

Board Secretary of the Multiple Sclerosis Society of Queensland Trevor Farrell announced that the Society would provide matching funding towards the fellowship.

Mr Farrell said MS was a devastating condition that attacked the central nervous system of people in the prime of their lives.

"The onset of the condition usually occurs when people are aged in their 20s to 40s. An estimated 16,000 Australians have MS, with 1000 new diagnoses a year," Mr Farrell said.

"This equates to a financial cost of $600 million per year, not to mention the physical and emotional effects it has on people for the rest of their lives."

In Australia, the human cost of MS, a neurological disorder, is growing at an alarming rate of 7 percent per annum and affects three times more women than men.

The new MS Senior Research Fellow at UQ's Queensland Brain Institute will investigate one of the primary effects of MS, the progressive loss of myelinating cells or oligodendrocytes.

The QBI was established in 2003 and is one of the largest neuroscience institutes in the world, focused on discovering fundamental mechanisms underlying brain-disease processes.

It has already established a core of world-renowned leading neuroscientists, under the direction of its founding Director, Professor Perry Bartlett, who is a Fellow of the Australian Academy of Science, Federation Fellow and UQ Foundation Chair in Molecular Neuroscience.

Professor Bartlett said the QBI had established a formidable array of technologies and, together with state-of-the-art facilities, was poised to progress research efforts into reducing the effects of brain disorders.

He said QBI researchers were dedicated to unlocking the mysteries of the many neurodegenerative diseases and mental health disorders, which currently accounted for a staggering 45 percent of the burden of disease in Australia.

"Public generosity helps QBI to continue much-needed research, funding new facilities, programs, research and scholarships," he said.

People wishing to support the new fund for the MS Senior Research Fellowship through gifts or donations can contact the University's Office of University Development and Graduate Relations development.uq.edu.au or telephone 07 3346 3909.

The MS Society of Queensland promotes research to cure MS and provides equitable, high quality specialised services for the benefit of people with Multiple Sclerosis.

To support the work of the Multiple Sclerosis Society of Queensland, please contact 07 3840 0888 or visit msaustralia.org.au/qld/weneedyou/index.htm.

Long-term Care: To Buy or Not to Buy?

Posted on : Thu, 22 Feb 2007 17:18:00 GMT | Author : The Lloyd Group Inc.
News Category : PressRelease

SUWANEE, Ga., Feb 22 /PRNewswire-USNewswire/ -- As long-term care becomes an increasingly "hot topic" as baby boomers enter retirement, many retirees are left with the confusing question: "Should I buy long-term care insurance? Is it worth it?"

A long-term care policy is one way of protecting your assets if you or your spouse falls ill. Similar to a personalized financial plan, long-term care policies are as unique as the buyers themselves. Speaking with your financial advisor can provide you with necessary information tailored to your specific situation and needs.

Mark Lloyd, the president and founder of Suwanee, Georgia-based asset protection and estate planning firm, The Lloyd Group, Inc. has outlined the important points to help boomers decide if long-term care insurance is right for them:

1. Odds of using long-term care The odds of needing long-term care in your lifetime are now up to 70 percent. That is far greater a risk than an auto accident or a house fire.

2. Spend Down Today, many retirees risk spending down their entire life savings in long-term care needs before they die, leaving nothing to their heirs or their surviving spouse. The most common governmental benefit is provided by Medicaid; a married couple can have approximately $100,000 in savings and still qualify for nursing home benefits through Medicaid. A single patient has to spend their savings to $2,000 before they are eligible for those same benefits.

3. Independence Most retirees want to be independent as long as they can, even with the simple things such as driving themselves to the store or doctor appointments.

4. Longevity Americans are living longer. There are more people over the age of 100 today than at any other time in our history.

5. Recovery Purposes Although long-term care is associated with seniors, there are some interesting statistics regarding a younger population. One of the largest group carriers in the U.S. found that in 2006, almost 58 percent of the long-term care claims handled were for people under the age of 65. The average claim for this age group lasted a year or longer. The analysis showed that 30 percent were cancer claims and more than 10 percent were strokes. The additional leading causes of claims were neurological disease, dementia and multiple sclerosis.

6. Underwriting Changes Insurance companies during the past 40 years have found out that more policy holders who have purchased these policies have kept them longer than anticipated. In the past, many companies priced their plans anticipating a certain amount of policies lapsing. This meant extra profit for the company. When the numbers of lapsed policies were less than expected, claims increased, forcing them to re-evaluate underwriting guidelines.

7. Government Encouragement Recently, federal and state governments have been on a push for people to purchase their own long-term care policies. One reason is: the more people that purchase long-term care insurance -- the less that will tap into the Medicaid and Welfare programs. The strategy behind this is three-fold. First, it is tougher to qualify for Medicaid. Strategies that were once used by elder law attorneys and certified estate planners are now against the law. Secondly, some states have developed co-op programs to encourage residents to purchase long-term care policies. In most cases, whatever the value that the policy will pay, it will be matched by the state in free long-term care benefits in the future. In this situation, it is important to note that most states have a cap on benefits. Thirdly, tax qualified long-term care policies may be tax deductible.

8. Law Changes The federal government and some states have changed the rules on what Medicaid applicants can do to qualify for benefits. One of the major changes that took place on February 2, 2006 was the enactment of the Deficit Reduction Act (DRA). This law changed the rules on "look-back periods" for gifting from 3 years to 5 years. Also, if a gift were made -- whether being money or property -- the penalty calculation would be figured from the date of application to Medicaid, instead of the old law, which started from the date of the gift. One other difference pertains to the usage of Life Estate Survivorship deeds. The new law may treat them as if the gift never took place for Medicaid eligibility.

9. Estate Recovery If a person needs Medicaid for their long-term care 49 out of 50 states have already adopted laws that attach a lien against the equity in one's home, making it so that when the Medicaid patient and their spouse, passes away, the state will require payment back for the monies that they contributed toward their healthcare.

10. Health-care flexibility One of the most popular health care choices is using at-home health care. With good home health care benefits available in most long-term care policies, this choice is often a reality. Many policyholders use the home health care benefit to provide a sitter or a home health aide to help with daily activities. Some of the more common illnesses that utilize home health care include: Alzheimer's disease, cancer, stroke and illnesses that affect stability and mobility.

This article was written by Mark Lloyd, his credentials include Certified Senior Advisor, Certified Estate Planner, Registered Financial Consultant, and a member of the prestigious Million Dollar Roundtable.

Mark is available to comment as an expert resource on all matters involving retirement planning, including asset protection, 401 (k), IRA and pension plan rollover options, estate tax, long-term care strategies, as well as other senior-focused financial concerns.

Founded in 1994 by Mark Lloyd, The Lloyd Group Inc. solely serves the distinctive financial needs of those nearing retirement and those already retired. The Lloyd Group Inc. is a member of the Metropolitan Atlanta Better Business Bureau and The National Institute of Certified Estate Planners. Lloyd is also the host of "Focus on Retirement," the greater Atlanta area's leading radio show devoted to retirees.

The Lloyd Group Inc.

Copyright © 2007 PR Newswire. All rights reserved.

Group sues feds over medical marijuana claims

LISA LEFF
Associated Press

OAKLAND, Calif. - Armed with a new study that showed smoking marijuana eased pain in some HIV patients, medical marijuana advocates sued the federal government Wednesday over its claim that pot has no accepted medical benefits.

The lawsuit filed in U.S. District Court by Americans for Safe Access accuses the U.S. Department of Health and Human Services of engaging in "arbitrary and unlawful behavior" that prevents "sick and dying persons from seeking to obtain medicine that could provide them needed, and often lifesaving relief."

The Oakland-based advocacy group wants a judge to force the department and the Food and Drug Administration to stop giving out information that casts doubt on the efficacy of marijuana in treating various illnesses.

"The FDA position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science," Joe Elford, chief counsel for Americans for Safe Access, said in a statement.

California is one of 11 states where marijuana use is legal for people with a doctor's recommendation, but because the U.S. government does not recognize pot's medical benefits patients can still be arrested and prosecuted by federal authorities.

Last week, researchers from the University of California, San Francisco reported in the journal Neurology that a test involving 50 HIV patients showed that those who smoked pot experienced much less pain than those given placebos.

Americans for Safe Access said in the lawsuit that Health and Human Services has rejected its requests to retract the assertion that cannabis "has no currently accepted medical use in treatment in the United States," a position the agency has advertised since 2000.

Countering that statement by petitioning the government and distributing evidence that marijuana eases the symptoms of cancer, multiple sclerosis, HIV and other conditions has cost Americans for Safe Access more than $100,000, the group said in its suit.

The Department of Health and Human Services did not immediately have a response to the lawsuit.

ON THE NET

http://www.safeaccessnow.org

Cancer overtakes heart illness as the most common serious illness in men according to Irish Life figures

By Finfacts Team
Feb 21, 2007, 09:30


Cancer overtakes heart illness as the most common serious illness in men, according to Irish Life figures
Company pays over €76million in protection claims in 2006

New figures published today by Irish Life reveal that for the first time cancer has overtaken heart related illness as the number one cause of serious illness claims for men.

The findings are published as part of an analysis of the total payments made by Irish Life to life cover and specified illness cover customers in 2006. Irish Life is the largest life assurance provider in the country.

The figures also reveal that, when analysing claims for men and women together, cancer illnesses generated twice as many claims as heart related illnesses.

The company reported that of payments made to serious illness policy holders in 2006, 63% related to cancer ailments. This was a rise of 10% on 2005 figures. 24% of payments related to heart illness (a fall of 1% on 2005 figures). The remaining 13% relate to stroke (6%), multiple sclerosis (2%) and a variety of other illnesses (5%).

In common with the experience of previous years the most common illness amongst women was cancer, with over 85% of female claims relating to the disease (an increase of 9% from the 2005). Just 4% of claims relating to heart related illness (the same percentage as 2005).

In a reversal of previous years the payments made to male customers in 2006 show that 47% of claims relating to cancer related illness. This was an increase of 12% on 2005. 39% of claims accounted for heart related illness, in line with the 2005 figure of 40%.

Accidents accounted for 10% of all life cover payments made by Irish Life. 48% of payments made to those less than 40 years of age arose as a direct result of accidents. The figures showed that the average hospital stay experienced by customers was 8 days (a rise of 2 days from 2005 figures). The average age of those dying as a result of accident was just 41 years of age.

Announcing the results, Kevin Murphy, Head of Irish Life Retail, said, “During 2006 we paid a total of €76million, to over 2,200 customers of our life cover and serious illness cover products. The average payments made to life cover customers increased from €38,000 in 2005 to over €52,500 in 2006. The average payment made to specified illness customers rose from €48,000 in 2005 to €55,700 in 2006. Worryingly there seems to be an increase in the percentage of our customers suffering from cancer related illnesses. However, this increase may be partly due to people addressing the issues that lead to heart illness thus reducing the numbers experiencing heart ailments.”

New MRI method speeds MS diagnosis

FLORENCE, Italy, Feb. 21 (UPI) -- Italian researchers say they've found a way to make faster diagnosis of the milder form of multiple sclerosis.

The researchers say a new way of using MRI scans can catch the so-called "benign" form of the disease sooner than previous methods, ANSA reported.

The findings were published in the journal Brain.

ANSA said an estimated 2.5 million people worldwide are living with MS but the number could be much higher because of the difficulty of diagnosis.

While there is still no cure, disease-modifying drugs can slow the progression and control symptoms of the disease, ANSA said.

© Copyright 2007United Press International, Inc. All Rights Reserved.
United Press International, UPI, the UPI logo, and other trademarks and service marks, are registered or unregistered trademarks of United Press International, Inc. in the United States and in other countries.

Hormone repairs MS damage in mice

CBC News

A hormone produced during pregnancy helps to push multiple sclerosis into remission in mice, Canadian researchers have found.

Scientists have long known that MS tends to ease during pregnancy. The finding prompted Samuel Weiss of the Hotchkiss Brain Institute at the University of Calgary and his team to look at whether prolactin reverses damage from MS in mice.

The hormone prolactin leads to the regeneration of protective nerve coatings, Dr. Samuel Weiss says.
(CBC)
The results appear in Wednesday's issue of the Journal of Neuroscience.

Multiple sclerosis causes the body's immune system to attack the protective coating around nerve cells called myelin, leading to damage that cannot be repaired. Reduction in myelin leads to progressive loss of sensation and movement in MS.

Prolactin stimulates breast development and milk production and has been tested in humans for other reasons.

"It's early to be confident that prolactin will definitely work with people," said Weiss. "But prolactin represents the first example of any molecule, in this case a naturally occurring molecule, that can actually boost the repair of myelin."

Continue Article

New direction for research

While current MS treatments are designed to prevent new damage in patients in earlier stages of the disease, there is nothing to repair myelin that has already been destroyed.

"This may give us some ways to now focus on protecting the brain, as opposed to giving therapies that just reduce the attacks," said Dr. Jock Murray, a professor of medicine at Dalhousie University and founding director of its multiple sclerosis research unit.

The Calgary team compared pregnant and virgin female mice of the same age to count the number of myelin-producing cells. They found pregnant mice had:

Twice as many of the cells.
50 per cent more myelin coating their nerve cells after giving birth.
Twice as much new myelin after it was chemically destroyed.
Prolactin may help promote growth of myelin, although trials for MS treatments based on the findings remain about five years away.

Prolactin may also be beneficial for other diseases in which myelin is involved, such as spinal cord injuries and stroke, said Fred Gage of the Salk Institute, who did not participate in the research.

Multiple sclerosis affects about 75,000 Canadians.

The study was funded by the Canadian Institutes of Health Research and the Multiple Sclerosis Society of Canada.

Acorda Therapeutics Announces Positive Results of Phase 3 Study of Fampridine-SR on Walking in People with Multiple Sclerosis

Statistical Significance Achieved on All Three Efficacy Criteria Set Forth in SPA

Conference Call and Webcast at 8:30 am ET on September 25, 2006

HAWTHORNE, N.Y.--(BUSINESS WIRE)--Sept. 25, 2006--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (34.8 percent vs. 8.3 percent) as measured by the Timed 25-Foot Walk (p less than 0.001). In addition, the effect was maintained in this study throughout the 14-week treatment period (p less than 0.001) and there was a statistically significant improvement in the 12-Item MS Walking Scale (MSWS-12) for walking responders vs. non-responders (p less than 0.001).

The average increase in walking speed over the treatment period compared to baseline was 25.2 percent for the drug group vs. 4.7 percent for the placebo group. Increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS. In addition, statistically significant increases in leg strength were seen in both the Fampridine-SR Timed Walk responders (p less than 0.001) and the Fampridine-SR Timed Walk non-responders (p=0.046) compared to placebo. The Company intends to present comprehensive data at an upcoming medical meeting.

"We are delighted with the results from this trial, which are consistent with Acorda's prior Phase 2 study in people with MS. We will request a meeting with the FDA as soon as possible to discuss next steps for the Fampridine-SR program," said Ron Cohen, M.D., President and CEO. "Acorda is committed to the development of therapies that will improve the function and lives of people with MS, and we wish to thank the physicians and people with MS who participated in this trial."

"Many people with MS experience nerve damage that eventually impairs walking. Currently, no therapies are indicated to improve neurological function, such as loss of mobility, in MS," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "Based on the results of this trial, Fampridine-SR could represent a new way to treat people with MS. In this study, a significantly higher proportion of subjects experienced a consistent improvement in walking speed with Fampridine-SR than with placebo, and this was accompanied by a reduction in the degree of disability that the subjects reported in their daily activities related to mobility."

Special Protocol Assessment (SPA)

This clinical trial was conducted under an SPA from the FDA. The efficacy criteria set forth in the SPA included three elements:

To show that there were significantly more responders in the Fampridine-SR treated group than in the placebo group, as measured by the Timed 25-Foot Walk, a standard neurological test. A responder was defined as someone whose walking speed on the Timed 25-Foot Walk was consistently greater during at least three of four on-drug visits than the person's fastest speed on any of the five off-drug visits.
To demonstrate statistically significant improvement in walking speed on the last on-drug visit for the Fampridine-SR-treated responders compared to the placebo group.
To show that responders reported a significantly greater improvement than non-responders on the MSWS-12, a self-rated assessment of walking disability. This step was meant to validate the clinical meaningfulness of consistent improvement on the Timed 25-Foot Walk.
Study Design

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The trial, which enrolled 301 individuals at 33 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. The study was open to people with all types of MS, including primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including interferons. Secondary endpoints for the trial included measurements of leg strength. Subjects were randomized to 14 weeks of treatment with Fampridine-SR (n=229) or placebo (n=72), a 3:1 ratio of drug to placebo.

Safety Statement

In this study, adverse events were largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS, including an increased risk of seizures that appears to be dose related. Following is a list of the most common adverse events reported in the study, with percentages representing the Fampridine-SR treatment group vs. the placebo group: falls (15.8 percent vs.15.3 percent), urinary tract infection (13.6 percent vs.13.9 percent), dizziness (8.3 percent vs. 5.6 percent), insomnia (8.3 percent vs. 4.2 percent), fatigue (6.1 percent vs. 2.8 percent), nausea (6.1 percent vs. 4.2 percent), upper respiratory tract infection (6.1 percent vs. 9.7 percent), asthenia (5.7 percent vs. 6.9 percent), back pain (5.7 percent vs. 0 percent), balance disorder (5.7 percent vs. 2.8 percent) and headache (5.7 percent vs. 5.6 percent).

Two serious adverse events that were judged potentially related to treatment and led to discontinuation were anxiety in one subject and a seizure in another subject that was observed during an occurrence of sepsis associated with a urinary tract infection. No deaths occurred during the study. One death was reported for a subject five weeks after the last on-drug study visit. This death occurred outside of the protocol time window for reporting adverse reactions and the cause of death is not known at this time.

About MS

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Approximately 80 percent of people with MS experience some form of walking disability. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and in later stages, about a third of patients are unable to walk.

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.

Fampridine-SR Mechanism of Action

A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.

In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. Fampridine-SR blocks these exposed channels, and helps the electrical signals to pass through areas of damage.

Conference Call and Webcast

Acorda will hold a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the top-line results from the trial. To access the call, please dial 866-510-0704 (domestic) or 617-597-5362 (international) five minutes prior to the start time, and provide the access code 20529997. A replay of the call will be available from 10:30 a.m. Eastern Time on September 25, 2006 until 11:59 p.m. Eastern Time on October 25, 2006. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 88067926. An audio webcast of the call can also be accessed from the Company's website, at http://www.acorda.com, for the next 30 days.

Patient Information Line

Patients with questions regarding the results of this study, or, who want to join Acorda's mailing list to be kept informed of future company news, may call 877-223-5212, toll-free, weekdays from 10:00am to 5:00pm ET.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.


CONTACT: Media:
Acorda Therapeutics
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Cell: 914-282-0836
ewishner@acorda.com
or
Porter Novelli
Marion E. Glick, 212-601-8273
Cell: 917-301-4206
marion.glick@porternovelli.com
or
Investors:
Stern Investor Relations
Sarah Lux, 212-362-1200
sarah@sternir.com

SOURCE: Acorda Therapeutics, Inc.

Stem Cell Advances in Treating Alzheimer's and Multiple Sclerosis

The use of pure cord blood stem cells by a team of research doctors in Mexico has resulted in breakthrough improvements in patients with Alzheimer's disease and progressive multiple sclerosis.

Tijuana, Mexico (PRWEB) February 17, 2007 -- The International Spinal Cord Regeneration Center has been spearheading research and clinical use of pure cord blood stem cells since March 2003. Recently breakthrough developments were documented involving Alzheimer's disease and progressive multiple sclerosis.

Alzheimer's:
A 72 year old female Alzheimer's patient from the U.S. (Mrs. M.) who had little short term memory ability by mid-summer 2006 experienced the recovery of this vital mental function in the months following a catheter infusion of purified cord blood stem cells in Mexico.

MRIs of the patient's brain during July 2006 showed that her brain had shrunken considerably, one of many markers that led her neurologists in Michigan to diagnosis her has having Alzheimer's disease. Her blood and all other vital organs were normal and showed no sign of disease.

On August 28, 2006 Mrs. M. received approximately 40 million pure cord blood stem cells by catheter infusion directly into her brain at the International Spinal Cord Regeneration Center in Tijuana Mexico (Fernando Ramirez, MD, Founder & Director). A team of doctors including an interventional radiologist, a anesthesiologist, and a surgeon performed the procedure which took approximately 30 minutes.

Within five weeks of having received the cells, Mrs M's husband was reporting improvements in her ability to form new memories and recall them hours and days later. This ability has persisted and even improved since Mrs. M's treatment almost 6 months ago.

Medical records and post-treatment tests showing Mrs. M's remarkable turnaround are being used to draft a formal paper for submission to a major peer-reviewed medical journal.

A 2nd treatment for Mrs. M. is being planned for the near future.

Multiple Sclerosis:

Jim Haverlock, 67, has struggled for thirteen years with progressive multiple sclerosis, an insidious neurologic disease which has steadily eroded his balance, energy and ability to speak clearly and walk without a cane.

During November 2006 Jim received an IV (intravenous) drip infusion of cord blood stem cells that had been genetically modified to express a growth factor called ciliary neurotrophic growth factor (CNGF). This particular growth factor has been shown to encourage remyelination of demyelinated nerves in animal models.

By early February Jim was reporting high levels of physical and mental energy, better balance and the ability to crisscross his house on foot without a cane (Something nearly impossible prior to the stem cell treatment).

Jim , who is very active in terms of helping out fellow MS sufferers and their families, welcomes queries by phone at 1-509-997-0204 (9 AM to 5 PM Pacific Time). Jim has posted a chronicle of his response to stem cell therapy online at http://14ushop.com/flyin-blind

International Spinal Cord Regeneration Center (Tijuana, Mexico) founder and director, Fernando Ramirez, M.D. has done over 400 cord blood stem cell treatments during the past 4 years. A pilot study on the positive effects of cord blood stem cells on cerebral palsy in children during 2004 was published in the online biomedical journal, "Medical Research & Hypotheses" and is available for access by the public by going to http://www.journal-mhr.com/PDF_Files/vol_3_2/3_2_PDFs/3_2_2.pdf

In addition, a 90 minute documentary concerning the International Spinal Cord Regeneration Center's cord blood stem cell program is available from the producer, Dr. Burton Goldberg www.burtongoldberg.com A eight minute clip from this documentary can be seen free-of-charge by going to Dr. Goldberg's website.