2006 WAS A GOOD YEAR FOR MS:

During 2006, rapid research progress was made in the fields of science and medicine that impact understanding and treatment of multiple sclerosis, an unpredictable neurological disease.

Significant advances have been made in both clinical and laboratory studies in MS. In addition, more than 130 clinical trials are underway around the world, and still other experimental drugs are in the pipeline. Key highlights of the year include:

Acorda Therapeutics (Hawthorne, NY) announced positive results of a Phase 3, placebo-controlled clinical trial of Fampridine-SR, an oral drug designed to provide symptomatic relief by compensating for lost nerve conduction. In 301 patients with all types of MS, those on active treatment showed an average increase in walking speed of 25% versus those on inactive placebo. The company is expected to meet with the U.S. Food and Drug Administration (FDA) to determine next steps needed to apply for marketing approval.

The FDA approved the return to market of Tysabri(R) (natalizumab, produced by Biogen Idec and Elan Pharmaceuticals) to delay the accumulation of physical disability and reduce the frequency of relapses (clinical exacerbations) in those with relapsing MS. There is now in place a mandatory registration program for patients and prescribing physicians to minimize the risk of PML (progressive multifocal leukoencephalopathy), caused by a common virus called the JC virus. The drug is dispensed at registered infusion centers across the country. Since Tysabri's return to market last summer, there have been no new cases of PML reported.

Members of the four Nervous System Repair teams from Europe and the U.S. met to share progress being made in the Society funded Promise: 2010 initiative. The first clinical trials focused on protecting the nervous system will begin shortly, and trials aimed at repairing damage and restoring function in people with MS are expected to begin within the next five years.

In a first, Johns Hopkins University researchers reported that nerve cells derived from mouse embryonic stem cells that were transplanted into rats with spinal cord injury were able to connect with muscles and partially restore function. While this work was done in a model of spinal cord injury, it bears relevance to the potential use of cell replacement to repair damage in MS.

The Society will be sponsoring the first ever stem cell summit January 16-19 in San Francisco to explore the potential of the complete spectrum of stem cell options as they might relate to MS research and treatment. The by-invitation only meeting will bring together some 60 renowned scientists from around the world to examine stem cell prospects and strategies in MS. The results of this meeting are expected to set research directions and priorities to best determine the potential of all types of stem cells for treating this disease.

Researchers from the University of California, Los Angeles reported that administering Androgel(R) (testosterone gel applied to the skin) to 10 men with relapsing-remitting MS significantly improved cognitive function and slowed brain tissue loss. This study was funded by the Society's initiative on Gender Differences in MS and is expected to lead to additional research involving larger numbers of patients to confirm these early results.

In another offshoot from the Society's initiative on Gender Differences, UCLA investigators began the first large-scale trial of a sex hormone for the treatment of MS. The two-year, controlled clinical trial of estriol involves 130 women with early relapsing-remitting MS. If successful, this clinical trial will lay the groundwork for a larger, definitive trial that could lead to a new treatment option for women with MS. Its results may also have implications for women with other autoimmune diseases, such as rheumatoid arthritis.

Several oral MS therapies continued to progress through the pipeline:

-- a phase II controlled clinical trial of oral fingolimod (FTY720, Novartis Pharmaceuticals Corp.) in 255 people with active, relapsing MS found that up to 77% of those taking fingolimod remained free of relapses over two years; a large phase III trial is now underway;

-- oral cladribine (an immune-modulating drug by Serono), now being tested in an international Phase 3 clinical trial, has been designated by the FDA as a "Fast Track Product," which should expedite its future review;

-- a multicenter, phase II controlled clinical trial of oral BG00012 (an oral fumarate, Biogen Idec) led to a 69% reduction in active inflammation on MRI scans in 257 people with relapsing-remitting MS;

-- in an open-label, 144-week extension study of oral teriflunomide (an agent that may modulate T cells), those on placebo during the original trial who switched to teriflunomide experienced up to an 85% decrease in new, active areas of disease activity seen on MRI at week 144.

Harvard investigators reported that individuals who showed signs of significant exposure to the Epstein-Barr virus, which causes infectious mononucleosis and other disorders, were twice as likely to develop MS up to 20 years later. The study, funded in part by a grant from the National MS Society, adds to previous evidence linking the virus to the risk of developing MS, but does not prove that EBV actually causes MS. Other recent studies have suggested that smoking cigarettes may contribute to the risk of MS and MS progression, and that higher vitamin D intake may help protect against developing MS.

For the first time, the needs of children who develop MS-like symptoms are being addressed through the Society's nationwide network of comprehensive Pediatric MS Centers of Excellence, launched early this year. The 6 centers have committed to sharing critical resources and best practices such as MRI protocols and neuropsychological evaluations so that all families can benefit from the collective knowledge of the entire network. In addition to providing optimal care and support, these centers will build a framework for research into this patient population, which may also provide clues to adult MS.

Two genes that may contribute to making a person susceptible to developing MS have been identified by a group of European researchers known as the "GAMES" Collaborative Group. MS involves an immune-system attack on the body's own brain and spinal cord, and many genes are thought to contribute to susceptibility. The two candidate genes were singled out because they encode for a brain tissue component and an immune component. This work was supported in part by the National MS Society.

Researchers at Stanford University have uncovered evidence they believe may explain the role of a protein, osteopontin, in stimulating repeated relapses and disease progression as well as inhibiting spontaneous recovery from symptoms. This research, sponsored in part by the Society, could lead to new therapeutic approaches that target oseopontin's effect in the MS disease process.

The National MS Society launched a new postdoctoral fellowship program in MS rehabilitation research. The immediate goal is to recruit and train talented clinician-scientists in rehabilitation research specific to MS; the ultimate goal is to get more hands and minds working on ways to help people with MS maximize their abilities.
[SOURCE: MS SOCIETY]