Scientists Show Monoclonal Antibody Leads To Repair Of Myelin Sheath In Laboratory Study Of Multiple Sclerosis

Main Category: Multiple Sclerosis
Also Included In: Neurology / Neuroscience;  Pharma Industry / Biotech Industry
Article Date: 18 Oct 2007 - 4:00 PDT

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Researchers at Mayo Clinic have presented details from a preclinical study showing that a recombinant human monoclonal antibody, administered in a single low dose in a laboratory mouse model of multiple sclerosis, can repair myelin, the insulating covering over nerve fibers in the central nervous system.

The study was presented on October 9, 2007 at the American Neurological Association meeting in Washington, D.C.

"We are excited to be collaborating with Mayo on the development of this therapy," noted Andrew R. Blight, Ph.D., Chief Scientific Officer at Acorda. "The options for treatment of MS are still quite limited, and a new approach that could repair damage to the central nervous system would represent an important advance for the individuals who live with this disease."

In multiple sclerosis and some other disorders of the central nervous system, the immune system attacks and destroys the myelin sheath, causing the nerve to lose its ability to conduct electrical impulses from the brain to the body, resulting in the disabilities associated with those conditions.

The antibody, which was genetically engineered for large-scale production, binds to myelin and the surface of cells in the brain and spinal cord, triggering the cells to begin the repair process called remyelination. The study was conducted using a laboratory mouse model of chronic progressive multiple sclerosis in humans. The antibody was delivered alone and in combination with the steroid methylprednisolone; remyelination was detected in both instances.

The antibody is being developed by Mayo Clinic and Acorda Therapeutics. Under a license agreement between Acorda and Mayo Clinic, Acorda holds exclusive worldwide rights to certain patents and other intellectual property for this antibody related to use and treatment of central nervous system disorders, including multiple sclerosis. Both Acorda and Mayo will be working on the steps leading to a future Investigational New Drug Application (IND) and a Phase 1 clinical trial.

About Multiple Sclerosis

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. According to the National Multiple Sclerosis Society, approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

The NMSS estimates the direct costs of medical care for MS patients in the United States to exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules™ (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical product, Fampridine-SR, is in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

American Neurological Association