Corautus Genetics Announces Filing of Response to FDA Clinical Hold
Wednesday May 31, 7:58 am ET
ATLANTA, May 31 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (Nasdaq: VEGF - News), a clinical stage biopharmaceutical company dedicated to the development of new and innovative gene therapy products for the treatment of cardiovascular (severe angina) and peripheral vascular disease, announced today the filing of its response to the FDA clinical hold on the GENASIS trial which was imposed due to potential safety concerns with the delivery of its proprietary product candidate for the treatment of severe angina in the trial.
Richard E. Otto, President and Chief Executive Officer of Corautus, said, "On March 14, 2006, we announced the voluntary suspension of the GENASIS trial due to three events of pericardial effusion progressing to tamponade occurring in the few weeks prior to that date. We did not, and still do not, believe the events were related to the therapeutic; however, patient safety is a prime concern so we immediately took action. Subsequent to informing the FDA of our voluntary suspension, the GENASIS trial was placed on clinical hold. The rate of tamponade events experienced in the GENASIS trial was 1.36 percent or 4 out of 295 patients treated."
Mr. Otto continued, "A cross-functional team, with members from both Boston Scientific Corporation, developer of the Stiletto(TM) catheter system, and Corautus, has been diligently working over the past several weeks with our investigators and others to evaluate the events leading to the suspension of treatments. We have now developed and submitted to the FDA our response to the clinical hold. We believe we have appropriately investigated the events and have developed a plan for dealing with these issues in potential subsequent clinical trials evaluating VEGF-2 for the treatment of severe angina."
As reported on April 10, 2006, when enrollment in the GENASIS trial was terminated, 295 patients with severe angina had been treated. Subsequent to the termination, with the support of our investigators and their coordinators, Corautus continues to gather, on a blinded basis, what it believes will be very important clinical data on both primary and secondary endpoints from the GENASIS trial.
Mr. Otto continued, "We are pleased with the submission of our response to the clinical hold and anticipate working with the FDA to address their concerns. Also, as previously announced, we are on track with our plans to make a decision regarding the timing of our clinical database lock and subsequent analysis and review of the collected data for efficacy endpoints and safety information. We look forward to analyzing the data and continuing discussions with the FDA to determine an appropriate primary endpoint in a trial for the treatment of patients suffering from severe angina. We continue to be hopeful the information generated by our analysis may support the commencement of a Phase III clinical trial." |
