Phase 3 Data from Genetically Targeted Beta Blocker for Chronic Heart Failure Presented at ACC
March 20, 2009 - ARCA biopharma Inc., a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, said today two Gencaro (bucindolol hydrochloride) abstracts will be presented as poster sessions at the American College of Cardiology 58th Annual Scientific Session March 29-31, 2009 in Orlando, FL.
The abstracts present data from the pivotal Phase 3 BEST trial of Gencaro in patients with advanced chronic heart failure. Poster 170 is “All-Cause Mortality Endpoint Comparison in Large Beta-Blocker Heart Failure Trials: U.S. Versus Rest of World.” Christopher O’Connor, M.D., professor of medicine in the division of cardiology, chief of the division of clinical pharmacology in the department of medicine, and director of the Duke heart failure program at Duke University Medical Center, is scheduled to present a comparative analysis of U.S. versus ROW primary and other clinical endpoint data from the “MERIT,” “COPERNICUS,” and “BEST” trials in a poster presentation (ACC Poster Contributions 1024 – Myocardial Function/Heart Failure – Clinical Pharmacology) on Sunday, March 29, from 3:30 p.m. to 4:30 p.m. (eastern).
Poster 184 is “Beta-Blocker Evaluation of Survival Trial (BEST) Findings Show Benefit of Bucindolol in Moderate to Severe HF Patients, According to Prespecified Statistical Analysis Plan.” Michael Bristow, M.D., ARCA’s founder and chief science and medical officer, is scheduled to present unpublished results of the pivotal Phase 3 BEST trial of Gencaro in patients with advanced chronic heart failure analyzed according to the pre-specified regulatory statistical analysis plan in a poster presentation (ACC Poster Contributions 1024 – Myocardial Function/Heart Failure – Clinical Pharmacology) on Sunday, March 29, 2009, from 3:30 p.m. to 4:30 p.m. (eastern).
Dr. Bristow will also participate in two panel discussions. “Pharmacogenomics and the Failing Heart.” ACC Symposium 604 – The Role of Genetic Testing in the Diagnosis and Management of Heart Failure will be held Sunday, March 29 from 10:30 a.m. to noon (eastern). The second discussion is ACC Meet the Experts 211 – Hemodynamic Monitoring in Implanted Arrhythmia Devices, Monday, March 30, from 11 a.m. to noon (eastern).
ARCA biopharma's lead product candidate, Gencaro (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure and other indications. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted heart failure treatment. The new drug application for approval of Gencaro for the indication of chronic heart failure, including the proposed brand name, is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of May 31, 2009. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. The company’s second compound in development, NU172, is a direct thrombin inhibitor, which has completed Phase 1b development for use as a potential short-acting anticoagulant during medical or surgical procedures.
For more information: www.arcabiopharma.com
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