Shares of ARCA Biopharma Inc. (Nasdaq: ABIO) surged more than 87 percent in trading Monday after the company announced that the United States Food and Drug Administration (FDA) had given the company fast-track designation for its experimental drug Gencaro, a treatment for chronic heart failure.
The news Monday skyrocketed the shares to a high of $4.50 and ARCA Biopharma topped the Biggest Percentage Price Gainers among common stocks on Nasdaq.
Gencaro, the ARCA’s investigational, pharmacologically-unique beta-blocker and mild vasodilator, is designed to reduce cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.
Michael R. Bristow, President and Chief Executive Officer of ARCA stated, “Fast Track designation for the Gencaro development program is an important acknowledgement of the need for advancements in the treatment of patients with chronic heart failure, a disease afflicting approximately 6 million people in the United States with approximately 550,000 new cases diagnosed each year.”
The FDA employs fast-track status is to expedite the review of drugs to treat serious diseases and fill unmet medical needs. ARCA plans to submit a study protocol to the USFDA under the administration’s Special Protocol Assessment (SPA) during the fourth quarter of 2009. ARCA expects to commence clinical trials in late 2010 or the first half of 2011 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.
Bristow continued, “If the SPA is approved by the FDA and the Company is able to obtain financing, this proposed clinical trial would be the first full sized cardiovascular trial performed in a genetically defined subpopulation to predict efficacy enhancement by the tested drug. As such, the proposed trial would be a landmark undertaking in pharmacogenetic drug development.”
ARCA biopharma began operations in 2005 and is headquartered in Broomfield, Colorado. ARCA is a biopharmaceutical company dedicated to developing genetically targeted therapies for heart failure and other cardiovascular diseases.