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FDA Accepts New Drug Application for Bucindolol, A Genetically-Targeted Treatment for Heart Failure From ARCA biopharma
Date:9/23/2008

BROOMFIELD, Colo., Sept. 23 /PRNewswire/ -- ARCA biopharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for the company's lead product candidate, bucindolol, an investigational and pharmacologically unique beta-blocker and mild vasodilator developed for the treatment of chronic heart failure. If approved by the FDA, bucindolol could become the first genetically targeted cardiovascular therapy.

Bucindolol significantly reduces both hospitalizations and deaths in heart failure patients with a specific, common genetic variation compared to placebo, according to results from a prospectively defined genetic sub-study of the Beta Blocker Evaluation of Survival Trial (BEST), a large Phase III clinical trial funded and conducted by the National Institutes of Health and the Veterans Affairs Cooperative. This data was presented this week by Christopher O'Connor, M.D., director of the Heart Center at Duke University Medical Center, at the Heart Failure Society of America (HFSA) annual meeting in Toronto.

"Bucindolol has the potential to become an important new treatment for heart failure. Clinical responses to bucindolol are substantially enhanced when administered to genetically targeted heart failure populations," said Michael R. Bristow, M.D., chairman, chief science and medical officer, and founder of ARCA biopharma. "This makes it possible for physicians to personalize treatment with the goal of improving patient outcomes, reducing hospitalization and avoiding the 'trial and error' process that is common in treating heart failure patients today."

Dr. Bristow, along with Stephen Liggett, M.D. of the University of Maryland, conducted genetic research to identify heart failure patients who are most likely to respond to bucindolol therapy. This genetic subgroup constitutes approximately 50 percent of the U.S. heart failure population.

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SOURCE ARCA biopharma, Inc.
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