Arca Obtains FDA Fast Track Designation For Gencaro

Arca biopharma (Arca) has receives FDA Fast Track designation for Gencaro, the company’s investigational, pharmacologically beta-blocker and mild vasodilator. It is intended for the reduction of cardiovascular mortality and cardiovascular hospitalisations in a genotype-defined heart failure population.

The company plans to submit a 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 3,000 patients with chronic heart failure, who have the genotype that appears to respond most favorably to Gencaro.

Arca anticipates that the proposed trial protocol will be a comparison to the beta-blocker metoprolol CR/XL, which is approved for heart failure and other indications. The company believes that the proposed trial protocol will involve an interim data analysis at a pre-specified number of primary endpoints, which could serve as the clinical effectiveness basis for FDA approval, if the results meet certain predefined criteria.

The company said that if agreed to by the FDA, it anticipates that the proposed trial could reach the specified number of endpoint events as soon as approximately two years after the trial begins.

Additionally, the company expects that the SPA submission will propose that a composite of cardiovascular mortality and cardiovascular hospitalisation serve as the primary endpoint of the trial. Any proposed trial protocol must be reviewed and agreed on by the FDA and the final trial protocol may be different from the company’s initial SPA submission.

The company is expected to submit the study protocol for review under the SPA process in the fourth quarter of 2009. Subject to the timing and outcome of the FDA’s review of the SPA submission, and subject to the company’s ability to obtain sufficient funding, the company currently expects it could begin the proposed trial in late 2010 or the first half of 2011.

Michael Bristow, president and CEO of Arca, said: “Fast Track designation for the Gencaro development program is an important acknowledgement of the need for advancements in the treatment of patients with chronic heart failure.”

“If the SPA is approved by the FDA and the company is able to obtain financing, this proposed clinical trial would be the first full sized cardiovascular trial performed in a genetically defined subpopulation to predict efficacy enhancement by the tested drug. As such, the proposed trial would be a landmark undertaking in pharmacogenetic drug development.”