Corautus Genetics Announces Steering Committee for GENASIS Trial
ATLANTA, Jan. 7 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (Nasdaq: VEGF - News) today announced the formation of the Steering Committee for its GENASIS ("Genetic Angiogenic Stimulation Investigational Study") Phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of severe cardiovascular disease.
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The Steering Committee will be co-chaired by Dr. Douglas W. Losordo, Chief, Cardiovascular Research, Caritas St. Elizabeth's Medical Center, Boston and Dr. Richard E. Kuntz, Co-director, Center For Clinical Investigation, Brigham and Women's Hospital, Boston. Other members of the Committee are: Dr. Timothy D. Henry, Director, Clinical Research, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis; Dr. Robert D. Simari, Professor of Medicine, Mayo Medical School, Rochester, Minnesota; and Dr. Byron Williams, Jr., Chief of the Department of Medicine, Crawford W. Long Hospital of Emory University, Atlanta.
In making the announcement, Richard E. Otto, President and Chief Executive Officer of Corautus said, "We are honored to have such a distinguished group to provide guidance in our GENASIS trial. We believe that they clearly represent the thought leaders for angiogenic cardiovascular research and bring to our trial expertise in trial design, clinical research, regulatory planning and statistical analysis." Mr. Otto added, "This is the appropriate time to form the Committee as we have launched the GENASIS trial nationally and currently have 15 medical centers qualified for enrolling patients. To date, 28 patients have been treated. This is the largest angiogenesis clinical trial underway for the treatment of severe coronary artery disease in the United States and we look forward to the guidance of the Steering Committee."
The GENASIS clinical trial is a randomized, double-blinded, dose-ranging and placebo-controlled trial that will enroll up to 404 patients with Class III or IV angina in approximately 25 cardiac medical centers in the United States. Angina results from coronary artery disease and manifests as chest pain due to a lack of adequate oxygen supply to the heart muscle. Class III and IV angina are the most severe forms of this condition, affecting more than one-third of the 400,000 newly diagnosed cases in the United States each year. The GENASIS trial will evaluate the efficacy and safety of defined doses of VEGF-2 delivered percutaneously via the Boston Scientific Corporation (NYSE: BSX - News) Stiletto(TM) endocardial direct injection catheter system. |
