http://www.pae.nmss.org/news/010401.htm

Dateline:  January 4,  2001

Thanks to the hard work of tens of thousands of volunteers, walkers, bikers and a host of other donors, the year 2000 was one of significant advances in both laboratory and clinical studies in MS. As the largest private supporter of MS research, the National MS Society has been at the core of many of these advances. Throughout the year, the National MS Society's volunteer scientific advisors reviewed 275 MS research proposals and approved 117 as being of scientific merit and relevance. New funding commitments totaling $3.4 million were made in the targeted research areas of gender differences, genetics and other projects. With the additional research projects, the National MS Society has commit to funding a total of over 300 projects to find the cause, treatment and cure for MS.

Key highlights include:

• The U.S. FDA approved Novantrone© "for reducing neurologic disability and /or the frequency of clinical relapses" in people with secondary-progressive MS, progressive-relapsing MS, or worsening relapsing-remitting MS. This is the first drug approved in the U.S. for treating secondary -progressive MS. The MS Society funded some of the first studies of Novantrone in laboratory rodents with the MS-like disease EAE, which helped move this agent into clinical studies.

• National MS Society -supported investigators at Mayo Clinic reported success in promoting the regrowth of myelin in mice with MS-like disease by injecting them with immune-system proteins called "monoclonal antibodies." Additional research is ongoing in advance of possible clinical trials in humans with MS.

• The National MS Society convened an international task force to refine and improve diagnostic procedures to reflect our better understanding of MS and advances in technology, especially MRI. A consensus publication laying out new guidelines for diagnosing MS is in preparation, which is anticipated to be widely adopted by the medical community.

• The first large clinical trial of an experimental oral therapy for MS began in spring. The "CORAL" trial, conducted by Teva Pharmaceutical Industries, is testing an oral form of Copaxone© in 1,300 people with relapsing-remitting MS over 56 weeks to determine whether it can reduce the rate of MS relapses. Another study involving Copaxone, led by University of Maryland researchers, suggested that over six years of therapy, Copaxone continues to have positive effects against relapsing-remitting MS.

• Two separate clinical trials testing two forms of interferon beta-1a (Avonex® and Rebif®) suggested that both drugs delayed development of MS based on the appearance of brain lesions, or areas of myelin destruction. To follow up, the MS Society launched the "MS LESION PROJECT," a five-year, $1.8 million international research project to correlate clinical manifestations of MS and findings from MRI and brain tissue samples. This targeted research initiative, centered at Mayo Clinic, is the largest grant awarded in the history of the National MS Society.

• Researchers at Cleveland Clinic and elsewhere showed that treatment with Avonex had beneficial effects no a number of cognitive functions among people with relapsing MS.

• Berlex Laboratories announced mixed results from its North American clinical trial of Betaseron® for secondary-progressive MS. In the study, the drug failed to slow progression of disability but did reduce annual relapse rates and accumulation of brain lesions detected by MRI. The company submitted results from these and from a more successful European trial to the FDA for consideration for approval to expand Betaseron's use to people with secondary-progressive MS.

• A small study testing the ability of oral modafinil (Provigil) to fight fatigue, a common and potentially disabling symptom of MS, showed promising results in MS. Modafinil is currently FDA-approved for the treatment of narcolepsy.

• Investigators in the U.S. and the United Kingdom reported that several derivatives of marijuana, called cannabinoids, could temporarily relieve spasticity and tremor in mice with MS-likes disease. A large-scale trial of capsules containing extracts of marijuana and its component THC is now underway in Britain to determine whether it can help control spasticity in people with different forms of MS.

• The National MS Society convened an international task force of clinicians, statisticians, ethicists, and regulators to generate ethical guidelines for the use of placebos in MS clinical trials. They concluded that placebo-controlled clinical trials in forms of MS for which partially effective therapies exist are ethical, so long as study subjects are fully apprised of the availability of such therapies and are encouraged to take them.