Acorda Therapeutics(R) Initiates Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis.

HAWTHORNE, N.Y. -- Acorda Therapeutics announced today that it has initiated a pivotal, Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). The study, which is based on a Special Protocol Assessment (SPA) issued by the Food and Drug Administration (FDA), will evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS.

The primary outcome measure for the study will be an improvement in walking ability; secondary outcomes will include measurements of leg strength and muscle spasticity. The studies will enroll a total of 240 patients at approximately 30 of the leading MS clinical centers in the United States and Canada. Individuals who are interested in learning about study enrollment may call 877-716-2518, toll-free, weekdays from 10:00am to 4:00pm (EST).

"Walking disability is one of the most important areas of unmet medical need in this population," said Andrew Goodman, M.D., Director of the MS Center at the University of Rochester Medical School and chairman of Acorda's MS advisory group. "Today's MS therapies act to prevent relapses and slow the progression of the disease but do not address the considerable loss of function experienced by these patients. A drug that could improve walking ability would be a significant and complementary addition to the current array of available therapies." According to the NARCOMS (North American Research Committee on Multiple Sclerosis) patient registry, approximately 80 percent of people with MS experience some degree of walking impairment. Additionally, mobility issues tend to worsen over time and seem to be independent of the type of MS diagnosed.

Ron Cohen, M.D., President and CEO of Acorda Therapeutics, said, "Acorda's mission is to develop therapies that improve neurological function in people with MS, SCI and related neurological disorders. We are delighted to have launched this pivotal trial, which is a key milestone in the fulfillment of that mission."

About Multiple Sclerosis

According to the National Multiple Sclerosis Society (NMSS), approximately 400,000 people in the U.S. have been diagnosed with MS, and approximately another 10,000 people are newly diagnosed each year. MS is more prevalent in people of Northern European background and women and is generally diagnosed between the ages of 20 and 50. The National Institutes of Health (NIH) estimates that the annual economic, social and medical cost of treating MS in the US exceeds $2.5 billion.

MS is a degenerative disorder, of unknown cause, in which the immune system attacks and damages the insulating myelin sheath around nerve fibers in the brain and spinal cord. This loss of insulation blocks or diminishes the conduction of electrical impulses, causing a "short circuit". The loss of conduction with MS can occur at multiple sites in the brain and spinal cord.

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). It is being studied in human clinical trials for both MS and spinal cord injury (SCI). In laboratory studies fampridine has been shown to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.

The most recent multi-center, Phase 2 clinical trial enrolled 211 patients with MS. The data showed a positive trend for improvement in average walking speed as measured by the Timed 25 Foot Walk, and a statistically significant improvement in leg muscle strength as measured by the Lower Extremity Manual Muscle Test. These data are consistent with from the results of earlier Phase 2 trials.

Adverse events, including serious adverse events, seen in previous clinical studies were insomnia, paresthesias (numbness/tingling), dizziness and nausea, the majority of which were rated as mild to moderate. Seizure was reported in a small number of patients, at higher doses than are currently being evaluated. As Fampridine-SR is an investigational drug, safety and efficacy have not been fully determined.

About Acorda Therapeutics

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