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ARCA biopharma Inc Announces IND Submission To US FDA For Gencaro For The Treatment Of Atrial Fibrillation


Tuesday, 29 Oct 2013 08:00am EDT 

ARCA biopharma, Inc announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the GENETIC-AF clinical trial of Gencaro (bucindolol hydrochloride), a pharmacologically beta-blocker and mild vasodilator being developed for atrial fibrillation (AF). 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 AF prevention treatment. The Data Safety Monitoring Board (DSMB) for the GENETIC-AF trial has been established. It is comprised of experts in the fields of cardiology, electrophysiology and statistical analysis, particularly in clinical development. 

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24 Apr 2015