arca biopharma inc (ABIO) Key Developments
ARCA biopharma, Inc. Announces Activation of First Canadian Genetic-AF Clinical Trial Site
Dec 11 14
ARCA biopharma, Inc. announced the activation of the first GENETIC-AF clinical trial site in Canada. The site activation follows on the August 2014 acceptance by Health Canada of the company's Clinical Trial Application (CTA) for the GENETIC-AF clinical trial evaluating GencaroTM as a potential treatment for atrial fibrillation (AF). This site brings the total current number of active trial sites to thirty-three. ARCA plans to activate a total of approximately 60 clinical trial sites in the United States and Canada for the Phase 2B portion of the trial. ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for AF in the Phase 2B/3 GENETIC-AF clinical trial, which is now enrolling patients in the United States and Canada. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it potential to be the first genetically-targeted therapy for the prevention of atrial fibrillation.
ARCA biopharma, Inc. Receives FDA Orphan Drug Designation for rNAPc2 as a Potential Treatment for Ebola
Dec 10 14
ARCA biopharma, Inc. announced that the U.S. Food and Drug Administration(FDA) Office of Orphan Products Development has granted orphan drug designation to rNAPc2 as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus. The drug candidate has previously demonstrated post-exposure efficacy in non-human primate models of Ebola hemorrhagic fever virus (HFV). rNAPc2 was originally developed as a cardiovascular therapy for thrombosis and other indications. As a result, it has an extensive human clinical record, and has been safely tested in over 700 human patients in nine Phase 1 and 2 clinical trials for cardiovascular disease.
ARCA biopharma, Inc. Announces Executive Changes, Effective December 31, 2014
Dec 1 14
ARCA biopharma, Inc. announced three management team transitions. Patrick Wheeler, Chief Financial Officer, has notified ARCA of his intent to leave the company in order to pursue other career opportunities after having served ARCA for 9 years. He will remain with the company through December 31, 2014 to assist in the transition of his responsibilities. Brian Selby has been promoted to Vice President, Finance and Chief Accounting Officer. He will report to the CEO and be responsible for ARCA's internal and external financial reporting, including compliance with the rules and regulations of the U.S. Securities and Exchange Commission, and corporate financing activities. Mr. Selby has been the company's Controller for 7 years and has extensive experience in corporate accounting and finance. Prior to joining ARCA, he worked at several public companies, including Controller for Myogen, Inc. and Controller for Genomica Corporation. Thomas Keuer has been promoted to Chief Operating Officer. He will report to the CEO and be responsible for pharmaceutical operations, human resources, facilities, and information technology. Mr. Keuer has been the Company's Executive Vice President, Pharmaceutical Operations for the past 8 years. Prior to joining ARCA, he served in a number of senior leadership positions in the biopharmaceutical industry including SVP of Operations for Insmed, Inc., VP of Engineering for Baxter Healthcare, and VP of Operations for Somatogen, Inc.
ARCA biopharma, Inc. Announces Health Canada Acceptance of GENETIC-AF Clinical Trial Application
Aug 18 14
ARCA biopharma, Inc. announced that the company's Clinical Trial Application (CTA) for the GENETIC-AF clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation (AF) has been accepted by Health Canada. ARCA anticipates that clinical trial sites in Canada will be active in the fourth quarter of 2014. ARCA is evaluating Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a potential treatment for AF in the Phase 2B/3 GENETIC-AF clinical trial, which is currently enrolling patients in the United States. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it potential to be the first genetically-targeted therapy for the prevention of atrial fibrillation. AF is a disorder in which the normally regular and coordinated contraction pattern of the heart's two small upper chambers (the atria) becomes irregular and uncoordinated. The irregular contraction pattern associated with AF causes blood to pool in the atria, predisposing the formation of clots potentially resulting in stroke. AF increases the risk of mortality and morbidity due to stroke, congestive heart failure and impaired quality of life. The approved therapies for the treatment or prevention AF have certain disadvantages in patients with heart failure and/or reduced left ventricular ejection fraction (HFREF) patients. GENETIC-AF is a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of Gencaro to Toprol-XL for prevention of symptomatic AF/atrial flutter in HFREF patients. ARCA plans to enroll only patients with the genetic variant of the beta-1 cardiac receptor which the Company believes responds most favorably to Gencaro. GENETIC-AF has an adaptive design, under which the Company initiated the trial as a Phase 2B trial in approximately 200 patients. The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain data from the Phase 2B portion of the trial and recommend, based on a comparison to pre-trial statistical assumptions, whether the trial should proceed to Phase 3 and seek to enroll an additional 420 patients.
ARCA biopharma, Inc. Presents at Rodman & Renshaw 16th Annual Global Investment Conference, Sep-10-2014 01:40 PM
Jun 13 14
ARCA biopharma, Inc. Presents at Rodman & Renshaw 16th Annual Global Investment Conference, Sep-10-2014 01:40 PM. Venue: New York Palace Hotel – 455 Madison Avenue, New York, NY 10022, United States.