Corautus Genetics Announces Update on GENASIS Trial
Thursday February 23, 8:00 am ET
ATLANTA, Feb. 23 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (Nasdaq: VEGF - News) 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 <.05. No inference should be drawn from this analysis about the ultimate efficacy results. However, the analysis suggests that fewer than 404 patients would be required to achieve the statistical significance originally contemplated in the design of our GENASIS trial.
"Notwithstanding the fact that the trial may be oversized based on this recent analysis, we will continue with our plan to treat 404 patients in the GENASIS trial", Mr. Otto continued, "as it will strengthen the reliability of the results of the trial and possibly provide a basis for a smaller Phase III trial than the GENASIS trial."
The GENASIS trial protocol is designed to evaluate efficacy results ninety days following patient treatment, with additional follow-up at 6 and 12 months. Corautus plans to perform an interim efficacy analysis shortly after completion of the ninety day evaluations. Corautus has been in discussions with the FDA about how best to accomplish this without compromising data for the 6 and 12 month follow-up. In addition, the FDA has indicated a heightened interest in the therapeutic's longer term efficacy and safety data that may result in changing the primary efficacy measurement in a later trial from ninety days to 6 months or 12 months.
"We have made a significant investment in the GENASIS trial, and we are taking the appropriate steps to protect the integrity of the trial data and to maximize the results from GENASIS in our overall clinical development strategy" said Mr. Otto. "We are working closely with the FDA to determine the best way to achieve all of our goals - facilitating rapid initiation of a Phase III trial and ensuring the data from the GENASIS trial are as robust as possible, to support optimal Phase III endpoints. The results of these decisions will determine whether efficacy results from the GENASIS trial will be available in the fourth quarter of 2006 or the first half of 2007. Our focus remains on implementing the most expeditious pathway to BLA submission and approval." |
