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December 5, 2013
08:33 EDTLH, ABIOARCA Biopharma announces IDE submission for Gencaro test
ARCA biopharma (ABIO) announced that Laboratory Corporation of America (LH) has informed ARCA that LabCorp has submitted an Investigational Device Exemption application to the U.S. FDA for the planned companion diagnostic test for Gencaro, a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. If accepted by the FDA, the IDE will allow the companion diagnostic test to be used in the planned GENETIC-AF clinical trial. ARCA’s Gencaro Investigational New Drug application for AF has been accepted by the U.S. FDA and is active. 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. LabCorp and ARCA have developed the companion diagnostic test for Gencaro to identify patient genotypes based on these genetic variations of the beta-1 cardiac receptor. LabCorp will provide the patient genetic testing for ARCA’s GENETIC-AF clinical trial of Gencaro, which is expected to begin patient enrollment in the first quarter of 2014.
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April 17, 2014
08:32 EDTABIO, LHARCA Biopharma announces screening of first patient in Phase 2B/3 trial
ARCA biopharma announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial. The GENETIC-AF trial will evaluate Gencaro as a potential treatment for the prevention of atrial fibrillation in patients with heart failure and/or left ventricular dysfunction who also have a specific genotype of the beta-1 adrenergic receptor, which is believed to be present in approximately 50% of the U.S. population. There are currently seven active clinical trial sites recruiting patients for GENETIC-AF. The company anticipates having approximately 50 clinical trial sites for the Phase 2B portion of the trial. Last week, ARCA hosted the initial GENETIC-AF Investigator Meeting which brought together the physicians and research coordinators participating in the trial for information sharing and study-specific training.

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