ARCA biopharma & Medtronic Extend Gencaro Clinical Trial Collaboration Agreement
ARCA biopharma, Inc. recently announced that Medtronic, Inc. has extended the US, Canadian, and European Clinical Trial Collaboration Agreement with ARCA for an additional year to April 2019.
Under the collaboration, Medtronic has supported clinical trial use of its continuous monitoring devices, managed atrial fibrillation burden data collection, and managed analysis of patients’ cardiac rhythms, via a Medtronic device, either a previously implanted cardiac resynchronization or defibrillation device, or a previously or newly inserted Reveal loop recorder.
Dr. Michael Bristow, MD, PhD, President and Chief Executive Officer of ARCA, commented “Medtronic has been a terrific partner in exploring and understanding atrial fibrillation in a clinical trial setting. We are excited to extend our collaboration as we continue analysis of the trial data from GENETIC-AF and consider potential future development plans for Gencaro.”
ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. ARCA’s lead product candidate, Gencaro (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and chronic heart failure with reduced left ventricular ejection fraction (HFrEF) which recently completed a Phase 2B clinical trial. 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. ARCA has a collaboration with Medtronic, Inc. for support of the GENETIC-AF trial. The Gencaro development program has been granted Fast Track designation by FDA. ARCA also plans to develop AB171, a thiol-substituted isosorbide mononitrate, as a potential genetically-targeted treatment for peripheral arterial disease (PAD) and for heart failure (HF). For more information, visit www.arcabio.com.
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