Acorda Therapeutics begins Phase 3 trials of Fampridine-SR for chronic spinal cord injury

July 01, 2002

Hawthorne, NY June 28, 2002 - Acorda Therapeutics announced today that it has begun two Phase 3 clinical studies of its lead product, Fampridine-SR, in chronic spinal cord injury. The trials will evaluate the safety and efficacy of Fampridine-SR in the treatment of moderate-to-severe spasticity associated with chronic SCI. Spasticity, which affects up to 75% of people with chronic SCI, manifests itself as involuntary stiffness or contraction of muscles.

The studies will enroll a total of 360 patients at more than 70 of the leading spinal cord injury (SCI) clinical centers in the United States and Canada. Individuals who are interested in finding out about participating in these studies may call 866-206-2322, toll-free, weekdays from 9:00 a.m. (EDT) to 7:00p.m. (EDT)

"There is significant demand for new treatment options in chronic spinal cord injury, especially spasticity. Spasticity is a serious complication of SCI that frequently interferes with movement and daily activities, and can cause severe pain or injury," said Ron Cohen, MD, Acorda's President and Chief Executive Officer.

Fampridine ("4-aminopyridine", "4-AP") enhances conduction in damaged nerves, and is the first compound shown to restore some neurological function to people with SCI. Fampridine-SR is an oral, sustained-release formulation of fampridine, designed for twice-daily dosing. The drug restores nerve conduction by blocking exposed potassium channels in demyelinated nerve processes, or axons. Fampridine-SR is also in Phase 2 clinical trials to evaluate safety and efficacy in the treatment of symptoms associated with multiple sclerosis (MS).

In previous SCI clinical trials, administration of Fampridine-SR has been shown to reduce spasticity, and to improve sexual function and bowel and bladder control. The most common side effects observed with Fampridine-SR treatment have been pain, paresthesia, insomnia, dizziness, constipation, and nausea. At clinically anticipated doses, side effects have been reported as mild to moderate, transient and comparable to placebo.
About Spinal Cord Injury
Spinal cord injury occurs primarily in young adults; 55 percent of spinal cord injuries occur before the age of 30. There are approximately 10,000 new cases of traumatic spinal cord injury each year in the United States, and approximately 250,000 people in the US are living with a long-term, or "chronic," spinal cord injury. The most common causes of traumatic spinal cord injury are automobile accidents, violence, falls, and sports injuries.

More than 90 percent of new spinal cord injury patients survive their injuries and go on to become part of the chronic SCI population, living with their disabilities for an average of more than 40 years after injury. This combination of long term survival and severe disability makes SCI among the most expensive of all medical conditions. Estimated costs of care for SCI patients exceed $9 billion per year in the U.S. alone, and over $1.5 million per patient lifetime.

Contrary to popular opinion, most people with a spinal cord injury do not have a completely severed spinal cord. Rather, they have a contused spinal cord, where the cord is stretched or compressed, causing tearing and bleeding. When an area of the spinal cord is damaged, motor and sensory functions are impaired throughout the parts of the body that are below the level of the injury. In addition, the body's involuntary or autonomic functions, including bladder, bowel and sexual functions, as well as blood pressure, breathing and temperature control are often affected by the injury.

About Fampridine-SR
Fampridine ("4-aminopyridine", "4-AP") enhances conduction in damaged nerves, and is the first compound shown to restore some neurological function to people with SCI.

Most people with a spinal cord injury have some axons, or nerve processes, that survive the injury. However, these surviving axons often are damaged and lose part of their myelin, the insulating sheath that permits electrical impulses to be conducted down the axon. When an axon is demyelinated, large numbers of these potassium channels are exposed and "leak" potassium ions, causing the axon to "short circuit", much like electricity in a wire from which the insulation has been stripped. Thus, even though a demyelinated axon is alive, it cannot transmit motor or sensory impulses and the patient effectively loses the use of it.

The major action of the compound is to block these specialized potassium channels on axons. By closing the exposed potassium channels, fampridine permits the axon to transmit impulses again, resulting in increased neurological function.

Fampridine-SR has been studied in clinical trials involving over 500 people with chronic SCI or multiple sclerosis (MS). Participants in these trials have shown improvements in a variety of impaired functions, including, in SCI, reduced spasticity, improved bladder, bowel, or sexual function, and in MS, improved walking speed and leg muscle strength.

Fampridine-SR is being developed by Acorda Therapeutics under a license agreement with Elan Corporation. Acorda Therapeutics obtained the rights to develop fampridine for therapeutic use in spinal cord injury from the Canadian Spinal Research Organization (CSRO). The CSRO, based in Richmond Hill, Ontario, is an organization that has funded spinal cord injury research programs since its inception in 1984.

About Spasticity
Spasticity refers to involuntary tension, stiffening or contractions of muscles. This condition occurs when the nerve cells in the spinal cord become disconnected from controlling centers in the brain, and therefore transmit unregulated impulses to the muscles. Up to 75% of individuals with chronic SCI experience some form of spasticity. Spasticity is also a common outcome of MS or stroke.

Most current treatments for spasticity are muscle relaxants, which reduce muscle spasms by decreasing muscle tone and interfering with the ability of muscles to contract. The most commonly reported side effects associated with these drugs are weakness, sedation and fatigue.

About Acorda Therapeutics
Acorda Therapeutics, a privately held biotechnology company, is developing therapies for spinal cord injury and related neurological conditions, including MS. In addition to Fampridine-SR, Acorda's technology platform includes human monoclonal antibodies that have been shown to remyelinate the central nervous system in animal models. These antibodies are in preclinical development for multiple sclerosis. Additionally, Acorda is developing protein- and stem cell-based technologies for regeneration and repair of the spinal cord and brain.

Porter Novelli

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