http://eon.businesswire.com/news/eon/20120203005039/en/acorda/ampyra/multiple-sclerosis
Acorda Therapeutics, Inc. (Nasdaq: ACOR) presented data showing that treatment with dalfampridine improved motor function in a preclinical model of stroke, with treatment initiated at least four weeks following the ischemic event. These data were presented on February 2 at the American Heart Association/American Stroke Association International Stroke Conference in New Orleans, LA. Dalfampridine, also known as 4-aminopyridine, is the active chemical ingredient in AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
“These are the first preclinical data to show an oral pharmacologic treatment can improve function in chronic, or long term, stroke. We are excited by these results and plan to begin proof-of-concept human clinical trials of AMPYRA in people with chronic stroke later this year”
“These are the first preclinical data to show an oral pharmacologic treatment can improve function in chronic, or long term, stroke. We are excited by these results and plan to begin proof-of-concept human clinical trials of AMPYRA in people with chronic stroke later this year,” said Andrew R. Blight, Ph.D., Acorda Therapeutics’ Chief Scientific Officer. “The majority of the nearly seven million people in the United States who live with the long term effects of a stroke have motor function deficits, such as walking impairment, but there are no established treatments other than physical therapy to address these impairments.”
A late-breaking science presentation, entitled “Dalfampridine Improves Sensorimotor Function in Rats with Chronic Deficits Following Middle Cerebral Artery Occlusion,” presented by Acorda scientist Jennifer Iaci, reviewed data from three study groups that received treatment beginning four weeks after a permanent middle cerebral artery occlusion (pMCAO). The neurological impairments that result are expected to be permanent by four weeks, which represents the chronic stage of stroke. Each group received three treatment phases over the course of the study: high and low doses of dalfampridine, and placebo. The order of the treatment phases was different for each group, with a 10 day washout period between each phase.
Researchers assessed functional improvement using a battery of standard motor function tests in both the forelimbs and hind limbs. In each of the three study groups, treatment with dalfampridine resulted in significant improvement in function compared to placebo across all measures during the respective treatment periods. Improvements in the high dose phase were consistently better than those seen in the low dose phase.
“In addition to the seven million Americans living with the consequences of a prior stroke, there are close to 800,000 people in the United States who have new stroke events each year. The resulting disability has a major impact on the person who suffers the stroke as well as on their caregivers, and places a significant burden on the healthcare system,” said Seth Finklestein, M.D., Chairman and Chief Scientific Officer of Biotrofix, a preclinical research organization that conducted research for this study in partnership with Acorda. “These are the first data from a well-controlled preclinical study that have demonstrated improvement in motor function related to walking and upper body movement. Developing a therapeutic option that can improve function would represent a potential major advance in the standard of care for stroke survivors.”
Acorda plans to begin a proof-of-concept trial of AMPYRA in stroke by the end of 2012. This study will evaluate the use of AMPYRA in stroke patients with chronic neurologic deficits, including walking impairment.
AMPYRA is approved in the United States as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. AMPYRA is known as prolonged-, modified-, or sustained-release fampridine (FAMPYRA®) in some countries outside the United States.
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