Patient enrollment in the so-called Genasis trial was expected to be complete by the end of March. However, the company has been slow to reach its target number of 404 participants, and now expects to complete enrolment by around June 30, 2006. To date, 276 patients have been treated in the trial.
“The additional time is primarily attributable to a decrease in the rate of enrollment which began in December and continued through January as well as delays in initiating several additional clinical sites for the study,” said Richard Otto, president and CEO of Corautus.
Mr Otto also said that the company was pleased with the overall progress of the trial, which it believes is the largest cardiovascular gene therapy study presently underway in the world.
The Genasis trial protocol is designed to evaluate efficacy results 90 days following patient treatment, with additional follow-up at six and 12 months. Corautus plans to perform an interim efficacy analysis shortly after completion of the ninety day evaluations. The company hopes to make results available in the fourth quarter of 2006 or the first half of 2007.