ARCA biopharma Receives Patent For Bucindolol

The patent (USP 7,678,824) entitled ‘Methods for Treatment with Bucindolol Based on Genetic Targeting,’ provides protection in the US for this approach to treat patients with heart failure, one of the largest health care problems in the US and the rest of the world.

ARCA had previously reported the notice of allowance of this patent. The company said that on March 25, 2010, it has submitted a revised clinical study protocol for review under the FDA’s special protocol assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.

An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Any proposed trial protocol must be reviewed and agreed upon with the FDA and the final trial protocol may be different from the company’s SPA submission.

If ARCA obtains sufficient funding and FDA approval of the SPA, ARCA currently expects to begin the proposed clinical trial approximately one year after such funding and approval. The FDA has previously designated as a fast track development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

Michael Bristow, president and chief executive officer of ARCA, said: “We are pleased with the USPTO’s issuance of this patent which we believe will extend our pharmacogenetic intellectual property protection around bucindolol and, if approved for marketing, provide Gencaro market exclusivity into 2025.”