ARCA biopharma, Inc. is a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases. ARCA began operations in 2005 and is headquartered in Broomfield, Colorado.
ARCA receives FDA FAST TRACK DESIGNATION FOR gencaroTM DEVELOPMENT IN GENOTYPE-DEFINED HEART FAILURE POPULATION
ARCA biopharma, Inc. (Nasdaq: ABIO) announced on November 23, 2009 that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM, the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. The Company intends to submit a study protocol for review under the FDA’s Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.
