Tuesday, May 13, 2008

Pediatric MS Affects Thinking, Memory





Researchers Say Multiple Sclerosis in Childhood Is Linked to Lower IQ Scores
By Kelli Miller Stacy

WebMD Medical News Reviewed by Louise Chang, MD

May 12, 2008 -- Multiple sclerosis (MS) that strikes during childhood may disrupt a key phase of brain development and appears to have a profound negative impact on a child's ability to think and pay attention.

Scientists reporting in the May 12 issue of Neurology say that the earlier MS develops, the more likely a child will have a lower IQ score.

MS is a central nervous system disease that attacks myelin, the material that covers and protects nerve fibers. The damage gets worse over time and leads to symptoms such as numbness, tingling, fatigue, loss of vision, and in severe cases, paralysis.

It most commonly develops in adults after age 20. However, pediatric MS affects about 8,000-10,000 people under age 18 in the U.S., according to the National Multiple Sclerosis Society.

Researchers theorize that pediatric MS strikes at a time when the part of the brain involved in cognition is maturing. Previous uncontrolled studies have shown a link between cognitive impairment and MS. However, information about the neuropsychological effects of MS in children and teenagers has been limited.

"It's possible that MS can show an even more dramatic effect on the thinking skills and intelligence in children than in adults, since the disease might affect the brain at a time when it is still developing," researcher Maria Pia Amato, MD, of the University of Florence in Italy, states in a news release.

Amato gave an array of intelligence tests to 63 children with MS and compared their scores to 57 healthy children of similar ages. The tests were designed to measure overall intelligence, memory, language ability, and other thinking skills.

The tests showed that the children with MS were more likely to have low intelligence scores and problems with memory, attention, and other thinking skills. Thirty-one percent of the children with MS met the criteria for significant cognitive impairment, meaning they failed at least three of the tests. Fifty-three percent of the children with MS failed at least two of the tests.

Amato's team noted language difficulties in about 30% of the children with MS. Language problems are uncommon in adults with the disease.

"Since the disease occurs during a critical phase for language development, children may be particularly vulnerable to language problems," Amato states. "Even subtle language difficulties are likely to have important functional consequences. Therefore ... assessment of language function in pediatric MS deserves particular attention in future studies," she writes in the journal article.

© 2008 WebMD, LLC. All rights reserved.

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Gender influences MS’ effect on brain





By LOIS BAKER
Contributing Editor

A new multiple sclerosis study conducted by UB neurologists has shown that in addition to affecting women two-to-three times more than men, multiple sclerosis (MS) damages different regions of the brain in men and women.

The differences were defined by analyzing brain scans of 795 MS patients and 101 healthy controls using conventional magnetic resonance imaging (MRI) techniques, plus more advanced nonconventional MRI techniques, such as diffusion weighted imaging and magnetization transfer imaging.

Results of the study were presented recently at the annual meeting of the American Academy of Neurology.

The research showed that MS in women results in more atrophy of the brain’s white matter, the network of nerves that transport messages to the various brain regions, while the condition in men appears to cause more atrophy in the brain’s gray matter, the regions where messages are received and interpreted.

Ronald Antulov is first author on the study. He conducted the research while a neuroimaging fellow at the Buffalo Neuroimaging Analysis Center (BNAC), part of the Jacobs Neurological Institute, which is the Department of Neurology in the School of Medicine and Biomedical Sciences.

Antulov and colleagues examined consecutively 620 female and 175 male MS patients who were seen at the institute and compared scans with those of the healthy controls. All were assessed using conventional and nonconventional MRI measures.

“We found that atrophy of gray matter and central brain regions was more advanced in men, while atrophy of white matter was more advanced in women,” said Antulov. The phenomenon was not observed in healthy controls.

“We think these changes are influenced by a decrease in sex hormones,” Antulov said. “A recent study showing that male MS patients receiving testosterone treatment showed a lower rate of brain volume decline supports this concept. This finding also suggests that higher levels of estrogen may protect women against more severe MS-related brain damage.”

The BNAC is applying for grants to extend this research.

Contributing to the study, all from the BNAC-JNI, were Bianca Weinstock-Guttman, Jennifer Cox, Sara Hussein, Jackie Durfee, Michael Dwyer, Niels Bergsland, Nadir Abdelrahman, Milena Stosic, David Hojnacki, Frederick E. Munschauer and Robert Zivadinov.

The study was conducted in collaboration with the University of Rijeka, Croatia. Vladimir Miletic of that university also contributed to the research.

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Fluoxetine (Prozac) Temporarily Slows MS Progression





By John Gever, Staff Writer, MedPage Today
Published: May 01, 2008

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

GRONINGEN, The Netherlands, May 1 -- The antidepressant drug fluoxetine (Prozac) curbed progression of relapsing-remitting multiple sclerosis in a small placebo-controlled study, but the effect lasted only a few months, researchers here said.

After 16 weeks of double-blind treatment, patients taking 20 mg/day of fluoxetine showed significantly fewer new lesions in MRI scans compared with patients receiving placebo, reported Jop P. Mostert, M.D., of the University of Groningen, and colleagues, online in the Journal of Neurology, Neurosurgery, and Psychiatry.

Twelve of 19 fluoxetine-treated patients had no new gadolinium-enhancing lesions at the 16-week evaluation, compared with five of 19 in the placebo group (P=0.02), they said.

However, the treatment phase lasted 24 weeks, and most measures of disease activity showed no significant differences between the fluoxetine and placebo groups at the study's final evaluation.

Still, the researchers wrote, "the results of our exploratory trial are sufficiently encouraging to justify further studies with fluoxetine in patients with multiple sclerosis."

They recommended that future trials use a higher fluoxetine dose combined with immunomodulating drugs.

The study was prompted by in vitro research and animal experiments suggesting that fluoxetine can modulate the activity of astrocytes, a class of immune cells in the brain, working to elevate cAMP signaling in these cells.

Astrocytes are involved in antigen-presentation and are thought to play a role in multiple sclerosis. They also carry serotonin receptors and reuptake sites, suggesting that serotonin reuptake inhibitors such as fluoxetine could reduce their activity.

Dr. Mostert and colleagues recruited 40 patients with established relapsing-remitting or relapsing secondary progressive multiple sclerosis who did not have a depression diagnosis. The mean time from first MS symptoms was 11 years.

Patients had no contraindications for repeated MRI scans or recent history of corticosteroids or immunomodulating drug therapy.

Participants were evaluated clinically and with MRI scans at baseline and at treatment weeks 4, 8, 16, and 24. One patient in each group discontinued prematurely, leaving 19 in each group for efficacy analysis.

At week 16, the mean cumulative number of new gadolinium-enhancing lesions -- the study's primary endpoint -- was 1.21 among fluoxetine-treated patients and 3.16 in the placebo group (P=0.05).

In addition to the larger number of patients showing no new lesions at 16 weeks, fluoxetine treatment was also associated with a smaller number of total scans showing new lesions (24% versus 47%, P=0.03).

Impressive-seeming numerical differences between groups remained at week 24, but the statistical significance largely vanished.

For example, the mean number of new enhancing lesions at week 24 was 1.84 in the fluoxetine group and 5.16 in the placebo group (P=0.15).

In the fluoxetine group, 32% of patients showed no new enhancing lesions at week 24, versus 21% of the placebo group (P=0.71).

Mean cumulative volume of new lesions at week 24 was 124 mm3 in the fluoxetine patients and 398 mm3 in the placebo group (P=0.16).

The only significant difference at week 24 was in the number of scans showing new lesions (25% in the fluoxetine group, 41% of the placebo group, P=0.04).

The number of patients having exacerbations and the total number of exacerbations did not differ noticeably between the fluoxetine and placebo groups.

Significantly more patients in the fluoxetine group reported nausea (65% versus 30% in the placebo group, P=0.03).

Other adverse effects did not differ significantly between groups, although 55% of fluoxetine patients reported drowsiness compared with 30% of those taking placebo.

The researchers noted that their small sample size limited the study's ability to detect significant treatment effects.

Nevertheless, they concluded, the results support their hypothesis about the role of cAMP signaling in astrocytes and its effect on inflammatory activity in multiple sclerosis.

The researchers added that fluoxetine may have other beneficial effects relevant to multiple sclerosis. For example, other studies have suggested it may help ward off axonal loss by stimulating release of neurotrophic factors.

The study was supported by Multiple Sclerosis anders [sic]. The researchers declared no potential conflicts of interest.

Primary source: Journal of Neurology, Neurosurgery and Psychiatry

Source reference:
Mostert J, et al "Effects of fluoxetine on disease activity in relapsing multiple sclerosis: A double-blind, placebo-controlled, exploratory study" Journal of Neurology, Neurosurgery, and Psychiatry 2008; DOI: 10.1136/jnnp.2007.139345

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Merck Serono Announces Initiation of Phase II Clinical Trial of Atacicept in Relapsing Multiple Sclerosis





Geneva, Switzerland, April 30, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner ZymoGenetics, Inc. (NASDAQ: ZGEN) today announced the initiation of a Phase II clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).

“This trial with atacicept underlines Merck Serono’s long-term commitment to patients with multiple sclerosis,” said Dr. Anton Hoos, Head of Global Development at Merck Serono. “Atacicept has the potential to complement existing MS drugs by offering a novel mode of action and convenient administration.”

“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”
The four-arm randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.

Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will be followed up until week 48.

About atacicept

Merck Serono and ZymoGenetics are developing atacicept (formerly referred to as TACI-Ig) as a potential treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis and multiple sclerosis, as well as B-cell malignancies.

Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as systemic lupus erythematosus. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, lupus erythematosus, B-cell malignancies and multiple sclerosis. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (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®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (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. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

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.

About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
With an annual R&D investment of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 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 an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.net or www.merck.de

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SLU Researchers to Test New Oral Medication for Multiple Sclerosis





Apr 29, 2008 - 4:38:53 PM


(HealthNewsDigest.com) - ST. LOUIS – Researchers at Saint Louis University are preparing to test an investigational pill to treat relapsing-remitting multiple sclerosis, the most common form of the potentially disabling neurological disease.

There are currently no oral medications approved to treat MS, which affects some 400,000 people in the United States (with approximately 10,000 new cases diagnosed each year). There are various medications to slow or modify the progression of the disease, but all must be injected into the skin, muscle or veins, making the search for an oral medication a top priority.

SLU will be one of several dozen sites around the world where researchers will study how patients with relapsing-remitting MS respond to the experimental drug laquinimod, which is taken in tablet form once a day. About 1,000 patients will be enrolled worldwide.

MS is a disease in which the body’s immune system attacks the protective coating – called myelin – surrounding the nerves within the central nervous system, as well as the nerve fibers themselves. Symptoms can vary widely from person to person, but they generally include fatigue, muscle weakness, numbness, impaired mobility, balance and cognition and vision disturbances.

About 85 percent of people newly diagnosed with the disease have relapsing-remitting MS. This form of the disease is characterized by periodic attacks or flare-ups (relapses), followed by months or even years of little to no signs of the disease (remission).

“Laquinimod seems to modulate how the immune system works,” said Florian P. Thomas, M.D., Ph.D., professor of neurology at the Saint Louis University School of Medicine and the study’s principal investigator. “In smaller, earlier trials, the drug reduced the likelihood of relapses in patients, as well as the number of MS lesions seen on MRI tests.”

In the randomized, double-blind study – the largest such investigation of the drug to date – half the volunteers will receive laquinimod while the remainder will be given a placebo.

They’ll remain in the trial for up to 30 months, during which time researchers will periodically assess how their disease develops. At various visits throughout the trial, patients will be given complete physical and neurological examinations, as well as an MRI scan to determine the extent of scarring on the brain – a defining characteristic of multiple sclerosis.

For the study, SLU researchers are looking for patients with relapsing-remitting MS between the ages of 18 and 55. Among other criteria, patients must not have taken any immuno-suppressive drugs within the last six months. Women must not be pregnant or breast feeding, and those of child-bearing age must be on at least two forms of birth control.

People wanting more information or to find out whether they qualify to participate in the study should call 314-977-4900.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.

www.HealthNewsDigest.com

© Copyright by HealthNewsDigest.com

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MorphoSys Announces Completion of First Dosing in Phase 1 Trial for MOR103 Program





04/28/2008 at 07:30 AM

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced the completion of a first dosing regimen in a phase 1 clinical study on healthy volunteers of the HuCAL-derived antibody MOR103 with no adverse events reported. Six healthy volunteers in the first dosing group have been enrolled and received MOR103 injections, while three volunteers received placebo. The safety review of the medical data from the lowest dosing group yielded a determination that it was safe to proceed with the second dosing group. The randomized, double-blind, placebo-controlled, single-ascending dose trial will be conducted in approx. 50 healthy volunteers and is being conducted in a Clinical Pharmacology Unit (CPU) in Utrecht, the Netherlands. The trial is scheduled to be finalized in 2008 and final reporting is expected in Q1 2009.

The Company's lead development program, MOR103, is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. MorphoSys had submitted the clinical trial application in December 2007 and received the approval by the Dutch authorities six weeks later. The study will evaluate the safety and tolerability as well as pharmacokinetics of escalating doses of MOR103.

"We are very pleased to see our first proprietary drug candidate progress according to plan," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Antibodies that neutralize GM-CSF could represent a new generation of medicines that reduce inflammation with greater beneficial effects."

For further information please contact: Dr. Claudia Gutjahr-Löser, Head of Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com

About MorphoSys:
MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys's goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The Company currently has therapeutic and research alliances with the majority of the world largest pharmaceutical companies including Boehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 50 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products. Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further information please visit http://www.morphosys.com/


About MOR103 to treat RA:
Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints and affects in particular a membrane, called synovium, which lines each movable joint. It is a disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. As a systemic disease, RA often affects extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and muscles. The disease affects approximately 4-6 million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium. Here, these blood cells appear to play an important role in causing the synovial membrane to become inflamed. The HuCAL-based antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases such as psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), asthma, and especially RA. The granulocyte macrophage colony-stimulating factor (GM-CSF) stimulates stem cells to produce granulocytes and macrophages, and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like RA leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103 reduces undesired proliferation and activation of inflammatory granulocytes and macrophages and intervenes in several pathophysiological pathways. More information and picture material is available at: http://www.morphosys.com/en/mor103


HuCAL® and HuCAL GOLD® are registered trademarks of MorphoSys AG


This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

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Minor injuries unlikely to trigger disease: judge





No strong evidence traumas like whiplash cause multiple sclerosis, B.C. Supreme Court rules

Ian Mulgrew
Vancouver Sun

Saturday, April 26, 2008

A decade-long, $3-million lawsuit about whether a minor injury can trigger or exacerbate the onset of multiple sclerosis has collapsed after the B.C. Supreme Court ruled the underlying theory is likely bogus.

After hearing from the world's foremost neurological authorities, Justice Austin Cullen concluded in a recent pretrial ruling that medical consensus no longer considers trauma to be a potential catalyst of the disease linked to the body's auto-immune system.

The lengthy and complicated decision abruptly ended this specific suit, involving the Insurance Corporation of B.C., but it also may halt lots of other outstanding litigation launched across the continent on similar grounds -- the now-debunked hypothesis put forward by renowned researcher Dr. Charles M. Poser.

From the Harvard Medical School and a senior neurologist with the Beth Israel Deaconess Medical Centre, Poser has been a leading figure in multiple sclerosis research for decades. He is broadly published and highly respected.

Yet in the legal community, many blame him for creating a "courtroom problem driven by medical hogwash."

Justice Cullen came down on their side. He pummeled the octogenarian doctor for giving at times contradictory evidence, misinterpreting medical studies and slanting his testimony.

"Dr. Poser, who was the primary witness for the plaintiff, testified as an advocate for a theory that once had currency but has since been eroded by the advance of scientific studies and knowledge," the justice wrote.

"I found in his evidence a tendency to overstate the implications of studies that he relied on, and to be unduly dismissive of those that undermined his theory. While he has clearly achieved the status of a foremost expert in his field of neurology, I find that his commitment to his own theory of causation has to some extent impaired his objectivity and reliability as an expert witness."

Kirsten Mehl, lawyer for the winning side, was ecstatic: "I don't think he'll come back to our jurisdiction -- we got him!"

She blamed Poser's pet hypothesis for having set off a brush fire of litigation around the globe. At one point, U.S. court activity spurred the American Academy of Neurology to appoint a panel of specialists in an attempt to douse the conflagration and the National MS Society in 2003 was forced to weigh in, too.

"This theory only had a life in the courtroom," Mehl insisted. "He created the theory and gave evidence all over the world. That's why a lot of claims were brought and settlements were made."

It was cheaper for insurance companies to settle than go to court and risk that a judge would consider the medical evidence but still back an injured individual also suffering the debilitating effects of MS. That will change.

Besides listening to international authorities, Cullen reviewed more than 100 reports, studies and medical articles. His conclusion should put an end to litigation based on the belief minor trauma can exacerbate MS.

Lawyers in this case say dispelling Poser's opinion and aura was difficult and expensive.

That is in part because he was doing exactly what scientists are supposed to do -- posit a theory and examine the evidence. And, as you might expect, he enthusiastically and passionately defended his ideas.

But what is useful in one profession can disrupt another.

Poser's curiosity and conjecture were fine in the lab; in the courtroom, his research and analysis muddied the waters of liability by raising the rare possibility of causation. Cullen clarified the issue.

"This is the first case in Canada to really go into this situation in depth," said Robert Hartshorne, a lawyer for the defence. "It is the first North American case which analyses what has occurred here medically and it should put an end to these suits. You couldn't afford to do this every time this allegation came up. We brought in experts from the U.S., England, around the globe."

Opposing counsel Ronald Nairne agreed: "ICBC drew a line in the sand and threw everything at this. And they did very, very well. There were a number of cases like this out there and they won't proceed now."

This case has its roots in a minor fender-bender at the entrance to the SkyTrain parking lot on 10th Avenue on May 22, 1998. Both cars were only slightly damaged and were driven from the scene.

Later, driver Harris Taylor reported that as a result of the bump, she had strained the muscles in her right arm, suffered a twinge in her lower mid-back, and experienced a bit of agitation in her right shoulder. She had a history of lower-back problems.

On Sept. 8, 1998, she was diagnosed with MS at Vancouver General Hospital. The advanced stage of the disease supported the conclusion that it had been latent for some years before the accident. Nevertheless, at that time, there was a noisy debate over the controversial theory first proposed by Poser in the 1980s -- that minor trauma, whiplash or seemingly insignificant head injuries could bring on or exacerbate MS.

Back then, there was contemporaneous litigation under way in Australia, the U.S. and the U.K.

Nairne said a B.C. colleague had successfully handled a similar case here in 1995 that was settled out of court. It was thought Taylor had a similar claim that could be successfully pursued. She sued the owners of the other car -- Linda and Timothy Liong -- for more than $3 million in damages, most of which was associated with the MS claim.

At issue was whether, on a balance of probabilities, trauma could alter the natural course of the multiple sclerosis, and the lawsuit was fought as a "test case."

To answer the question, Justice Cullen embarked on a lengthy voir dire -- a trial within a trial --to determine the admissibility of expert evidence about the possible causal connection between trauma, including mild head trauma or whiplash injury, and the onset of symptomatic MS. He chose to hear specialists from both sides.

Surprisingly, Cullen was guided in his reasoning by a legal decision made in Scotland about the time this well-aged action was launched.

In that 1998 ruling on a similar suit, judge Lord Rodger concluded: "I do not find it proved, on a balance of probabilities, that trauma in general, or whiplash injury in particular, can trigger the onset of symptomatic MS . . . . I am not satisfied that whiplash injury can ever cause the onset of symptomatic MS."

Though it didn't bind him, Cullen found the reckoning behind the ruling "compelling by its lucid, careful and thorough analysis and conclusion. The fact that since that decision was pronounced (but not because of it) the relevant scientific community can be seen as coalescing around the scientific proposition that no causal relationship exists between trauma and MS symptoms in light of additional studies and discoveries, can only lend weight to the guidance implicit in Lord Rodger's extensive judgment."

Referring to study after study, Cullen averred: "All represent an erosion of support for the theory of a causal link between trauma and MS symptom onset within the medical world."

The idea that trauma could trigger the onset or exacerbation of MS symptoms is not a novel theory in the sense of being new. Researchers since at least the 1930s had suggested a link between an injury and the disease. Poser, however, had become its primary advocate -- the last man standing, if you will.

In 1999, the therapeutics and technology assessment sub-committee of the American Academy of Neurology published a "special article" written by a blue-ribbon panel that included Dr. William Sibley of the University of Arizona, Dr. George Ebers of the University of Western Ontario and Dr. Douglas Goodin, director of the MS Center at the University of California, San Francisco Medical Center. All of them testified before Justice Cullen.

Dr. Goodin said that the subcommittee was formed to conduct an assessment of the association between trauma and MS onset or exacerbation in response to a person who "felt that this [issue] was being misused in the courtroom."

Subsequently, in 2003, the National MS Society published its position referencing the AAN article and two separate epidemiological studies:

"Both studies showed that there are more traumatic events among people with MS than in the healthy control group. Many traumas were caused by MS symptoms such as incoordination, impaired balance, or abnormalities with gait or vision. These events, however, were not precipitating factors in the onset or exacerbation of the disease."

Recent medical texts also reflect that view: a complete reading of the literature provides no direct evidence in support of the hypothesis that trauma influences the expression or natural history of multiple sclerosis. Justice Cullen found the consensus compelling:

"I find that the likelihood of a causal connection between trauma and MS exacerbation is significantly less than that of a coincidental connection, in light of all the evidence adduced, and the opinion of a substantial majority of the scientific community. I thus conclude that even on a robust and pragmatic view of the evidence, it does not support proof of a causal connection between mild trauma, including whiplash, and MS exacerbation, on a balance of probabilities."

Which might put an end to the controversy in the courtroom, but it should do nothing to deaden the curiosity and enthusiasm of medical researchers -- no matter how esoteric or eccentric.

imulgrew@png.canwest.com




WHAT IS MULTIPLE SCLEROSIS?

B.C. Supreme Court Justice Austin Cullin provided the following sketch in his judgment of multiple sclerosis and its effects:

Multiple sclerosis is believed to be an autoimmune disease and that in North America, about one out of 1,000 people will be diagnosed with the affliction.

Another one in 1,000 will go undiagnosed despite having the condition.

Women were historically at double the risk of men.

Surprisingly and somewhat alarmingly, that ratio has changed dramatically (by an increase in incidence among women, rather than a decrease among men) in the past 50 years.

This strongly suggests environmental factors at play.

MS is characterized by the appearance of patches of inflammation associated with demyelination (loss of fatty insulation of nerve fibres) in the white matter of the brain, brain stem, optic nerve and spinal cord.

These patches, also called plaques or simply lesions, often occur in crops and they cause the common symptoms -- visual loss, double vision, numbness and/or weakness of the limbs.

The advent of magnetic resonance imaging (MRI) in about 1985 greatly aided researchers.

There is believed to be a strong genetic influence on the development of MS as studies have shown a relatively high correlation among family members.

Though environmental factors are also believed to be involved, they are as yet largely unidentified.

As to the triggers of the disease, epidemiological studies implicate viral infections as potential triggers in roughly 25 per cent of the cases.

There is no general acceptance of what other triggers may be responsible for the remaining 75 per cent of MS onset or exacerbation.

© The Vancouver Sun 2008

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Friday, April 25, 2008

Accelerated Cure Project for Multiple Sclerosis is One Thousand Steps Closer to a Cure for MS





Nonprofit has collected 1,000 blood and data samples from MS sufferers and controls across the U.S.; Samples will be used in dozens of individual research studies this year


WALTHAM, Mass., April 23 /PRNewswire-USNewswire/ -- Accelerated Cure Project for Multiple Sclerosis, a national nonprofit organization, today announced that they have completed their initial drive to collect one thousand blood and data samples to build the largest openly accessible, multi-disciplinary repository ever assembled for use in Multiple Sclerosis (MS) research.

"This is a major milestone for the Accelerated Cure Project", says Art Mellor, founder of the Accelerated Cure Project. "Limited sample size is one of the most frequently cited reasons for inconclusive results in MS research. Our repository provides researchers with immediate access to a far greater number of samples than most scientists could collect themselves."

In addition, the repository will provide a common population of samples useful for a wide variety of different studies, which will enable results from different research perspectives to be easily combined and correlated. The repository contains various types of samples and data that can support scientists working in many fields - genetics, nutrition, virology, and more. Researchers gaining access to the repository must return their results to the database to be shared with other researchers; this will allow cross-correlation of their results with all other studies performed using the same samples.

Subjects enrolled in the repository will be followed over time to allow new samples to be taken and to record important changes in clinical status. Studying the same sample population over time, and pooling knowledge in a central database, is a major step toward understanding what causes MS, thereby accelerating a cure.

Additionally, samples and data are collected from a number of other similar diseases including Transverse Myelitis, Neuromyelitis Optica, ADEM, and Optic Neuritis to enable studies in these rare neurological disorders and to provide controls for MS studies.

Collection Sites

Contributing to the success of the project is an impressive list of research centers across the country that have joined Accelerated Cure Project as collection sites for the repository. These include Johns Hopkins Medical Center (Baltimore, MD), University of Massachusetts Memorial Medical Center (Worcester, MA), University of Texas Southwestern (Dallas, TX), Multiple Sclerosis Research Center of New York (New York, NY), Barrow Neurological Institute (Phoenix, AZ) and the Shepherd Center (Atlanta, GA).

The Accelerated Cure Project intends to continue collecting samples from as many as 10,000 subjects for its MS Repository. If you have MS (or another demyelinating disease) or are related to someone with MS and would like to participate in the project, please call 781/487-0008, visit acceleratedcure.org/repository, or send an email to info-web1207@acceleratedcure.org.

About Accelerated Cure Project

Accelerated Cure Project for Multiple Sclerosis, http://www.acceleratedcure.org, is a national nonprofit organization dedicated to curing Multiple Sclerosis (MS) by determining its causes. Accelerated Cure Project believes this effort can be accelerated by organizing the research process and encouraging collaboration between research organizations and clinicians. A "Cure Map" is currently being developed by the Accelerated Cure Project to establish what is known and what is not known about the causes of MS. From the Cure Map, Accelerated Cure Project will facilitate research most likely to reveal the causes of MS in the shortest time through a large-scale, multidisciplinary, MS Repository. For more information about the Accelerated Cure Project or to make a corporate or individual donation, call 781/487-0008, visit acceleratedcure.org, or send an email to info-web1207@acceleratedcure.org.

About Multiple Sclerosis

Multiple Sclerosis is a chronic demyelinating disorder of the central nervous system that often results in severe disability including the inability to walk, blindness, cognitive dysfunction, extreme fatigue and other serious symptoms. MS affects over 400,000 people in the US and 2 million individuals worldwide. The disorder occurs twice as often in women as in men. The cause is not known and there is no known cure.



SOURCE Accelerated Cure Project for Multiple Sclerosis

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Stem-cell treatment could reverse multiple sclerosis effects ‘within 15 years’





The effects of multiple sclerosis could be reversed with stem-cell treatment within 15 years, a leading expert on the disease said today.

Professor Charles ffrench-Constant, the director of a groundbreaking MS research centre in Edinburgh, said the treatment could be used to help patients suffering from the condition that weakens their body's central nervous system.

He said stem cells could be used to help repair nerve damage caused by MS. Currently, only medicines can help reduce the inflammation that causes MS.

Prof ffrench-Constant said he wants to find a way to make the body rebuild myelin – the sheath that protects nerve fibres – using stem cells, which have the ability to turn into different types of tissue.

He told The Herald newspaper: "My vision for a patient coming into a clinic in 10 or maybe 15 years' time is they will be given a mixture of drugs to prevent the inflammation and to promote repair.

"That way, MS would no longer be a chronic, disabling disease."

The MS research centre is part of the Scottish Centre for Regenerative Medicine at the University of Edinburgh.

It was launched thanks to a major donation from Harry Potter author JK Rowling, whose mother died from the condition.

MS affects an estimated 85,000 people in the UK

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Thursday, April 17, 2008

Opexa Therapeutics Presents Tovaxin Phase I/II Data at the American Academy of Neurology 60th Annual Meeting





THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced that Brian Loftus, M.D., of Bellaire Neurology and the Principal Investigator of the Tovaxin Phase I/II studies, presented data titled “Autologous Attenuated T-Cell Vaccine (Tovaxin®) Dose Escalation in Multiple Sclerosis Relapse-Remitting and Secondary Progressive Patients Nonresponsive to Approved Immunomodulatory Therapies” at the American Academy of Neurology meeting today. The AAN meeting is taking place at the McCormick Place West Convention Center in Chicago, IL.

The objective of the Tovaxin Phase I/II dose escalation study was to assess the safety and effectiveness of T cell vaccine (Tovaxin®) in MS patients non-responsive to approved immunomodulatory therapies. The trial results indicate statistically significant improvements from baseline observed using the annualized relapse rate and myelin-reactive T-cell count effectiveness measurements.

“The positive therapeutic effects of safety, early effectiveness and tolerability observed in this study suggest that depletion of myelin-reactive T-cells using Tovaxin, a trivalent T-cell vaccine, may be an appropriate treatment strategy for patients with MS and warrants further study,” said Dr. Loftus.

About T-cell Vaccination

For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.

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, 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 diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

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, obtain FDA approval for its therapeutic products, 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.

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FTY720, a novel oral therapy in development for MS, shows sustained





Phase II study extension shows 68-73% of patients with multiple sclerosis remained relapse-free after three years of treatment with oral FTY720[1]

New data demonstrate 89% of patients free from active brain lesions - the injury caused by MS - three years after starting treatment[1]

MS, a devastating disease causing progressive disability, affects 2.5 million people worldwide including many young adults[2]
FTY720 regulatory filings planned before end of 2009 in US and EU

Basel, April 15, 2008 - The investigational oral therapy FTY720 (fingolimod) continues to demonstrate sustained benefits in patients with multiple sclerosis (MS) after three years of treatment, according to new clinical data presented today from an ongoing Phase II study extension[1].

Results showed that 73% of patients who began the study on FTY720 5 mg remained free from relapses after three years, and 68% of those who began the study on FTY720 1.25 mg remained relapse-free[1]. The figures after two years of treatment were 77% and 75% respectively[3]. On the basis of comparable efficacy and a better safety profile, all patients have been transferred to FTY720 1.25 mg in the study extension.

The 36-month data also showed an average annualized relapse rate of 0.20[1], equivalent to one relapse in five years, while 89% of patients were free of the active brain lesions characteristic of MS as measured by magnetic resonance imaging (MRI)[1] three years after starting treatment.

The results were presented at the 60th annual meeting of the American Academy of Neurology (AAN) in Chicago, USA.

"These new data demonstrate the exciting potential for FTY720 to reduce relapse rates in MS patients with a convenient once-daily pill," said Professor Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele in Milan, Italy. "An effective oral treatment would be a significant breakthrough in the management of MS. That is why these results are encouraging - because we are seeing substantial benefits of FTY720 maintained over time in this clinical trial."

FTY720 is a novel, once-daily, oral treatment in worldwide Phase III clinical development for the treatment of relapsing-remitting MS, the form of the disease that affects approximately 85% of people diagnosed with MS[4].

More than 2.5 million people worldwide are affected by MS[2], the most common non-traumatic cause of neurological disability in young people[5]. Regulatory filings for FTY720 are expected in the US and EU before the end of 2009.

"The FTY720 Phase III program is the largest conducted in MS to date, and demonstrates our long-term commitment to the field of MS therapy," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "It is especially encouraging to see that FTY720 continues to demonstrate sustained efficacy by helping the majority of patients to remain free of relapses as the study progresses."

FTY720 has the potential to be the first in a new class of therapies for MS that act on inflammation by modulating sphingosine-1-phosphate receptors (S1P-R), reducing the number of inflammatory immune cells, called lymphocytes, from reaching the brain. In addition, FTY720 reaches the brain and S1P-Rs are present on central nervous system (CNS) tissue, so FTY720 may have a direct beneficial effect on MS within the CNS. This additional potential mechanism of action is supported by new preclinical data being presented at AAN[6],[7].

The Phase II study presented at AAN began with a six-month placebo-controlled phase in which 281 patients with relapsing MS received placebo, FTY720 1.25 mg or FTY720 5 mg once-daily. This was followed by a long-term extension in which all patients took FTY720. At the end of three years, 173 patients were in the extension, which is still ongoing. The study has been conducted in Canada and 10 European countries.

Results from the six-month placebo-controlled trial showed that FTY720 reduced relapse rates by more than 50% compared to placebo[5]. Current first-line therapies for MS reduced relapse rates by 30-35% on average in two-year studies[5].
Among patients originally on placebo who converted to active therapy in the extension, 51% were free of relapses at three years[1]. The figure at two years was 57%[3].

FTY720 has been generally well tolerated throughout the three years of the Phase II study and its extension, with the most common adverse events being nasopharyngitis, headache, fatigue and influenza[1]. Increases in alanine aminotransferase (liver enzymes) were observed in 16% of patients. Dermatological screening of patients was implemented in the extension after a small number of cases of localized skin malignancies were reported.

Novartis continues to study FTY720 in an ongoing, blinded Phase III clinical trial program. This program includes comprehensive monitoring that will further assess and characterize the safety profile of FTY720.

MS is caused by the destruction of myelin, which helps neurons carry electrical signals in the brain[8]. The disease causes problems with muscle control and strength, vision, balance, sensation and mental function[8]. MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or "relapses") followed by complete or partial restoration of functions.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "planned", "potential", "would", "encouraging", "expected", "commitment", "may", "continues", "will", or similar expressions, or by express or implied discussions regarding potential future regulatory filings or marketing approvals for FTY720 or regarding potential future revenues from FTY720. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with FTY720 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that FTY720 will be submitted to regulatory authorities for approval, or will be approved for sale in any market. Nor can there be any guarantee that FTY720 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding FTY720 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1.] Comi G et al. Oral FTY720 (fingolimod) in patients with relapsing multiple sclerosis. 3-year extension shows sustained low relapse rate and MRI activity. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[2.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx Accessed March 11, 2008.
[3.] Kappos L. et al. Oral fingolimod (FTY720) in relapsing MS: 24-month results of the Phase II study. ECTRIMS 2006.
[4.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx Accessed March 11, 2008.
[5.] Kappos L et al. Oral Fingolimod (FTY720) for Relapsing Multiple Sclerosis. N Engl J Med 2006;355, p. 1130.
[6.] Barske C et al. FTY720 (Fingolimod) and S1P-Receptor 1 and 5 specific Agonists Increase the Number of Oligodendrocytes in Vitro. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[7.] Schubart A et al. FTY720 suppresses ongoing EAE and promotes a remyelinating environment preventing axonal degeneration within the CNS. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[8.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx Accessed March 11, 2008.

# # #

Novartis Media Relations

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The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on Novartis website for historical purposes only. Novartis assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.

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BIOGEN IDEC AND ELAN PRESENT NEW TYSABRI® DATA AT THE 60th ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY





Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide

Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years

Chicago, IL - April 15, 2008 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI® (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN).

"These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.

"Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.

According to data available as of the end of March 2008:

In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;

Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;

In global clinical trials, more than 600 patients were on TYSABRI therapy; and

There have been no cases of PML since re-launch in the US and launch internationally in July 2006.

Cumulatively, in the combined clinical trial and post-marketing settings:

More than 36,700 patients have been treated with TYSABRI; and

Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.

TYSABRI is available in the U.S. through the TOUCH™ Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.

The abstract for this study, "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH™ and TYGRIS" (Presentation #S02.002), is available online at the AAN's Web site.

TYSABRI Increases the Proportion of MS Patients Considered Disease Free
Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. In the studies, the proportion of patients considered disease free over two years was significantly higher in the TYSABRI-treated group compared with the placebo group, regardless of how disease free was defined.

Clinically, disease free was defined as no relapses and no progression of disability (as defined by >1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of >1.0, or a >1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.

"The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.

In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free. Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS.

The abstract for this study, "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), is available online at the AAN's Web site.

About TOUCH™ and TYGRIS
Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.

TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.

Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.

About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.

TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by the FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market. Drug development and commercialization involves a high degree of risk.

For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Biogen Idec Important Information
Biogen Idec and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. Information concerning the interests of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. In addition, Biogen Idec files annual, quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy statements and other reports, when available, can be obtained free of charge at the SEC's web site at www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully any proxy statement filed in connection with the Company's 2008 annual meeting of stockholders when it becomes available before making any voting or investment decision. The Company's proxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at info@innisfreema.com.


For more information contact:

Media Contacts:
Biogen Idec
Shannon Altimari
617-914-6524

Elan
Jonathan Birt
212-850-5664

Elizabeth Headon
+ 353 1 498 0300

Investor Contacts:
Biogen Idec
Eric Hoffman
617-679-2812

Elan
Chris Burns
+ 353 1 709 4444
800-252-3526

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BioMS Medical’s Phase III U.S. Multiple Sclerosis Trial Receives Positive Safety Review from Data Safety Monitoring Board





Edmonton, Alberta, April 15, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company’s on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.

This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.

To date, more than 65% of the total number of required patients have been enrolled in the Company’s MAESTRO-03 clinical trial, with full enrollment anticipated for the end of the first half of 2008.

About MAESTRO-03
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be 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 (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).



About BioMS Medical Corp.
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 is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.



Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com A

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

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Genentech and Biogen Idec Announce Top-Line Results from a Phase II/III Clinical Trial of Rituxan in Primary-Progressive Multiple Sclerosis





South San Francisco, Calif. and Cambridge, Mass. -- April 14, 2008 -- Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) today announced that a Phase II/III study of Rituxan® (rituximab) for primary-progressive multiple sclerosis (PPMS) did not meet its primary endpoint as measured by the time to confirmed disease progression during the 96-week treatment period. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.

"We are disappointed in the outcome of the primary endpoint, but not surprised given the significant clinical challenges presented by PPMS," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "There was some evidence of biologic activity, and we will continue to review all the data to better understand the role of B cells in MS."

"While the primary results are not what we had hoped, we continue to believe in the potential of B cell therapy for patients living with MS," said Michael Panzara, M.D., MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec. "PPMS is widely considered a difficult form of MS to treat and historically no therapy has proven efficacy in this disease state."

About the Study
This Phase II/III randomized, double-blind, placebo-controlled, multi-center study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan in patients with PPMS. A total of 439 patients from approximately 60 sites in the U.S. and Canada were randomized 2:1 to receive either four treatment courses of Rituxan six months apart or placebo. MRI evaluations were conducted at baseline, weeks 6, 48, 96 and 122.

Detailed safety data from the study is currently being evaluated. The incidence of overall adverse events was comparable between Rituxan and placebo treatment groups. Serious adverse events were 16.4 percent in the Rituxan arm versus 13.6 percent in the placebo arm, with an incidence of serious infections of 4.5 percent compared with <1.0 percent respectively. Infectious events reported in at least 10 percent of patients in either group included upper respiratory and urinary tract infections. Most infectious events in the Rituxan arm were reported as mild to moderate in severity, though events of greater severity were reported more frequently in patients receiving Rituxan. There were more infusion-related reactions with Rituxan, the majority of which were mild to moderate in severity. The companies continue to monitor the long-term safety of Rituxan treatment.

About MS and PPMS
MS is a chronic autoimmune disease where the body's immune system attacks the myelin sheath causing inflammation and destruction of this fatty, protective substance. The myelin sheath surrounds the body's nerve fibers in the central nervous system, which includes the brain, optic nerves and spinal cord. There are four generally accepted disease courses of MS with a wide variety of symptoms and variations of disease progression.

Symptoms of the disease vary from patient-to-patient. Neurological disability typically accumulates over time and may include weakness or fatigue; numbness or tingling; blurred vision, impaired color perception or visual loss; poor coordination of muscle movements; difficulty with bladder or bowel control; muscle stiffness (spasticity); speech problems and challenges with cognitive skills.

PPMS affects approximately 10 percent of the MS population and is evident by the slow and continuous progression of the disease. People with PPMS can experience plateaus in the progression of their disability, but generally do not experience distinct periods of relapse or remissions. The progressive nature of PPMS and severe debilitation associated with the disease can have a devastating impact on a patient's quality of life and ability to function.

About Rituxan
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received Food and Drug Administration (FDA) approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin's lymphoma (NHL). It was also approved in the European Union under the trade name MabThera® in June 1998. In February 2006, Rituxan also received FDA approval in combination with methotrexate to reduce signs and symptoms and, in January 2008, to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.

CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These cells make antibodies that help fight infections.

Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after treatment with Rituxan in about 12 months for most patients.

In addition, Rituxan received FDA approval in February 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and in September 2006, also was approved for the treatment of non-progressing low-grade, CD20-positive, B cell NHL as a single agent, in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, and for previously untreated diffuse large B cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.

Over the past ten years, there have been more than 1 million patient exposures to Rituxan.

Important Safety Information
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). Hepatitis B reactivation and cardiac arrhythmias and angina have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs other than methotrexate are used concomitantly. Common adverse reactions (≥ 5%): hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.

In addition to PPMS, for which there is currently no FDA-approved therapy, Rituxan is also being studied in other autoimmune diseases for significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

This press release contains a forward-looking statement regarding the potential of B cell therapy for patients living with MS. Such statement is a prediction and involves risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors including, but not limited to, unexpected safety, efficacy or manufacturing issues, the need for additional data or clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and new product approvals and launches, and intellectual property or contract rights. Please also refer to the risk factors described in Genentech and Biogen Idec's periodic reports filed with the Securities and Exchange Commission. Genentech and Biogen Idec disclaim, and do not undertake, any obligation to update or revise any forward-looking statements in this press release.

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Pluristem's PLX Cells Show a Statistically Significant Advantage in a Pre-Clinical Study in the Multiple Sclerosis Model




2008-04-14 20:16:34 -

Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT) a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that a preclinical study utilizing the Company's PLacental eXpanded (PLX) cells showed a statistically significant advantage in ameliorating functional deficiencies in a standard Multiple Sclerosis (MS) animal model. PLX cells are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX(TM) technology.

Researchers at Pluristem utilized the Experimental Autoimmune Encephalitis (EAE) animal model for the study, the paradigm for MS in humans. After EAE was induced, a number of the animals were given PLX cells intravenously while the remaining served as a control. There was a significant reduction in the EAE score in those animals given PLX cells versus the control group and this beneficial effect was seen throughout the 25-day duration of the study. The EAE score is a measurement of functional outcomes in the EAE-afflicted animal and correlates closely with a histological improvement in EAE-induced lesions. Additionally, the beneficial effects were similar to when Zappia et. al. used MSCs that were non-placental in origin in this EAE animal model(1).

Zami Aberman, Pluristem's President and CEO said: "We are very excited that our PLX cells were able to demonstrate beneficial results that are statistically significant in this standardized model for Multiple Sclerosis. These results, in addition to our previously announced PLX STROKE results, demonstrate that PLX cells may be useful in the treatment of central nervous system (CNS) disorders and potentially help millions of people. Additionally, we believe this experiment demonstrates we can potentially utilize our off-the-shelf, easy to obtain PLX cells and achieve results that are as good as or better than MSCs obtained from other more difficult to find sources."

(1)Zappia et. al. Mesenchymal stem cells ameliorate experimental autoimmune encephalitis inducing T cell anergy. Blood. 2005;106: 1755-1761

About Multiple Sclerosis (MS)

Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminate, is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. Myelin is the insulating sheath that surrounds nerve cells (neurons). MS may cause numerous physical and mental symptoms, and often progresses to physical and cognitive disability. The World Health Organization (WHO) estimates that over 2.5 million people globally suffer from MS, which represents a current market of approximately $5.4 billion for disease-modifying agents to treat the disorder.

About Pluristem

Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and aut