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$8 million NIH grant will fund multicenter clinical trial of stroke intervention drug
Date:4/22/2014

LOS ANGELES (April 22, 2014) Cedars-Sinai stroke intervention researchers have been informed that the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will award an $8 million grant to fund a multicenter Phase II clinical trial of an experimental drug for stroke.

The drug, 3K3A-APC, will be used in combination with recombinant tissue plasminogen activator, or rtPA the "clot-busting" drug currently approved to treat ischemic strokes shortly after onset. In laboratory rodent studies, 3K3A-APC, used in combination with rtPA, had a protective effect on the lining of blood vessels, eliminating hemorrhaging, reducing brain damage, and improving animals' mobility after stroke. The new drug has completed a Phase I trial in 64 healthy volunteers to assess safety and dosing levels.

Ischemic strokes block arteries, depriving the brain of oxygen. The existing clot-buster, rtPA, may restore blood flow and often reverse the effects of a stroke if administered within three hours after symptoms begin. The drug, however, increases risk of internal bleeding in some patients, which can have brain-injuring and other harmful effects.

"Stroke is the fourth leading cause of death in the United States and a leading cause of disability, often leaving people to live out their lives with limited cognitive and physical skills. When patients receive rtPA within the three-hour time frame, the beneficial effects are often dramatic. But the drug is not without its limitations and potential side effects. Our objective in this and other studies is to spare more lives and livelihoods by making treatments more effective with fewer risks," said Patrick Lyden, MD, chair of Cedars-Sinai's Department of Neurology, director of the Stroke Program and the Carmen and Louis Warschaw Chair in Neurology.

The Phase II study will evaluate safety, tolerability and activity of 3K3A-APC when given after rtPA in patients wh
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Contact: Sandy Van
sandy@prpacific.com
808-526-1708
Cedars-Sinai Medical Center
Source:Eurekalert

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