arca biopharma inc (ABIO) Key Developments
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. Elects Robert E. Conway as Chairman of the Board of Directors
Jun 9 14
ARCA biopharma, Inc. announced that Robert E. Conway has been elected Chairman of the company's Board of Directors. He serves on the Audit and Compensation Committees of the Board of Directors. Mr. Conway has over 30 years of executive leadership experience in the pharmaceutical and biotechnology industries. Mr. Conway served as the Chief Executive Officer and member of the Board of Directors of Array BioPharma from 1999 to 2012. Prior to joining Array, Mr. Conway was the Chief Operating Officer and Executive Vice President of Hill Top Research, Inc., from 1996 to 1999.
ARCA biopharma, Inc. Announces Screening of First Patient in Phase 2B/3 Clinical Trial Evaluating Gencaro in Atrial Fibrillation
Apr 17 14
ARCA biopharma, Inc. 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(TM) (bucindolol hydrochloride) as a potential treatment for the prevention of atrial fibrillation (AF) in patients with heart failure and/or left ventricular dysfunction who also have a specific genotype of the beta-1 adrenergic receptor (389 arginine homozygous), 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. Gencaro is an investigational, pharmacologically unique beta-blocker and mild vasodilator. ARCA has identified common genetic variations that it believes may predict individual patient response to Gencaro, giving it the potential to be the first genetically targeted AF prevention treatment. Currently, no beta-blocker has been approved by the U.S. Food and Drug Administration for the prevention of AF. AF is considered an epidemic cardiovascular disease. The estimated number of individuals with AF globally in 2010 was 33.5 million. According to the 2014 American Heart Association report on Heart Disease and Stroke Statistics, the estimated number of individuals with AF in the U.S. in 2010 ranged from 2.7 to 6.1 million. AF increases the risk of stroke and may also contribute to worsening heart failure.
ARCA biopharma, Inc., Annual General Meeting, Jun 05, 2014
Apr 15 14
ARCA biopharma, Inc., Annual General Meeting, Jun 05, 2014., at 09:00 US Mountain Standard Time. Location: Denver Marriott Westminster Hotel. Agenda: To elect the board’s nominees, Dr. Michael Bristow and Mr. Robert Conway, to the board of directors to hold office until the 2017 annual meeting of stockholders; to ratify the selection by the audit committee of the board of directors of KPMG LLP as the independent registered public accounting firm of the company for its fiscal year ending December 31, 2014; and to conduct any other business properly brought before the meeting.
ARCA biopharma, Inc. Auditor Raises 'Going Concern' Doubt
Mar 21 14
ARCA biopharma, Inc. filed its 424B4 on Mar 21, 2014 for the period ending Dec 31, 2013. In this report its auditor, KPMG LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.