From rxpgnews.com
VEGF-2 gets Fast Track Designation for theTreatment of Severe Angina
By Corautus Genetics Inc.
Nov 4, 2005, 15:59
Corautus Genetics Inc. , a clinical stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to Corautus for Vascular Endothelial Growth Factor 2 ("VEGF-2") for the treatment of severe angina associated with cardiovascular disease.
"The FDA's decision to grant Fast Track designation to our VEGF-2 program is a significant milestone in the clinical development of our therapeutic to treat a large patient population with unmet medical needs," stated Richard E. Otto, President and Chief Executive Officer of Corautus. "Receiving this Fast Track designation is another step in our regulatory strategy that is designed to afford us the opportunity to accelerate the development of VEGF-2 to commercialization."
Mr. Otto continued, "The Fast Track application was submitted based upon the large unmet medical need that our VEGF-2 program addresses. Severe angina resulting from coronary artery disease is a serious, debilitating and potentially life threatening disease. We are pleased the FDA determined that our VEGF-2 program warranted this designation, and we looking forward to working with FDA to advance our clinical strategy."
Under the FDA Modernization Act of 1997, the Fast Track program was created to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life threatening diseases, and that demonstrate the potential to address unmet medical needs. Fast Track designated therapeutics are eligible for priority review (6 months versus the average 12 months) and/or the review of portions of the marketing application prior to the completion of the final registration package.
Corautus' GENASIS (GENetic Angiogenic Stimulation Investigational Study) clinical trial is the largest cardiovascular study of its kind and is evaluating the safety and efficacy of VEGF-2 for the treatment of severe angina associated with cardiovascular disease.
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