VEGF Corautus Genetics (MM)

ATLANTA, Feb. 23 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (NASDAQ:VEGF) announced today an update of its GENASIS Phase IIb clinical trial that is evaluating the safety and efficacy of VEGF-2 for the treatment of severe angina resulting from cardiovascular disease. Corautus expects to complete the enrollment of 404 patients in its Phase IIb GENASIS trial around June 30, 2006. Corautus had previously projected that it would complete enrollment by March 31, 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 E. Otto, President and Chief Executive Officer. "We are expecting to enroll approximately 30 patients in February and complete enrollment around June 30, 2006. Overall, we and our clinical steering committee are pleased with the rate of enrollment for GENASIS, which we believe is presently the largest cardiovascular gene therapy trial being conducted in the world." Corautus has received a blinded interim variability analysis of the GENASIS trial data for the first 171 patients treated in the trial. The GENASIS trial size was determined based on earlier Phase IIa results, to support a statistically significant determination of the effect of treatment in achieving the study endpoint. Without unblinding trial data to anyone involved with the conduct of the trial, independent biostatistician consultants have reviewed the GENASIS trial's primary endpoint data and have concluded that the GENASIS trial has greater than 90% power to demonstrate statistical significance on the primary endpoint, which is a greater than 60 second difference in exercise tolerance time between placebo and VEGF-2 with a two-sided alpha