ARCA biopharma receives Health Canada acceptance to start Genetic-AF trial of Gencaro

18th August 2014 (Last Updated August 18th, 2014 18:30)

ARCA biopharma (ABIO) has received acceptance from Health Canada for its clinical trial application (CTA) for the GENETIC-AF clinical trial evaluating Gencaro to treat atrial fibrillation (AF).

ARCA biopharma (ABIO) has received acceptance from Health Canada for its clinical trial application (CTA) for the GENETIC-AF clinical trial evaluating Gencaro to treat atrial fibrillation (AF).

The company expects the clinical trial sites in Canada to be active in the fourth quarter of 2014.

Currently, the company is enrolling patients in the US for the Phase IIb/III GENETIC-AF clinical trial to evaluate Gencaro, a pharmacologically unique beta-blocker and mild vasodilator, as a treatment for AF.

ARCA founder and CEO Michael Bristow said: "At ARCA, we believe a personalised medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each patient, can enable more effective therapies, improve patient outcomes and reduce healthcare costs.

"Gencaro has the potential to be the first genetically targeted treatment for the prevention of this important cardiovascular disorder."

"If the GENETIC-AF trial successfully confirms the atrial fibrillation data analysis from a prior Phase III clinical trial, Gencaro has the potential to be the first genetically targeted treatment for the prevention of this important cardiovascular disorder and provide a much needed treatment option for patients in an area of high unmet medical need."

The Phase IIb/III, multi-centre, randomised, double-blind GENETIC-AF clinical trial is comparing the safety and efficacy of Gencaro to Toprol-XL for prevention of symptomatic AF/atrial flutter in HFREF patients.

The company is planning to enrol only patients with the genetic variant of the beta-1 cardiac receptor.

GENETIC-AF has an adaptive design, under which the company started the trial as a Phase IIB trial in about 200 patients.

The GENETIC-AF Data Safety Monitoring Board (DSMB) will analyse certain data from the Phase IIb portion of the trial and recommend, based on a comparison to the pre-trial statistical assumptions, whether the trial should proceed to Phase III and seek to enrol an additional 420 patients.