Corautus Genetics, Inc. (NASDAQ:VEGF)
Industry: Healthcare

Listed 16 Consecutive Market Days. On List as of 08/24/2005 Through 09/16/2005

Corautus Genetics Inc. (Corautus), incorporated on June 30, 1995, is a biopharmaceutical company dedicated to the development and commercialization of gene therapy products for the treatment of cardiovascular and peripheral vascular disease. Corautus is focusing its efforts and resources on the clinical development of gene therapy product candidates using a growth factor known as Vascular Endothelial Growth Factor 2 (VEGF-2). The Company's VEGF-2 product candidates are designed to induce therapeutic angiogenesis, which is the stimulation of blood vessel formation, to restore blood flow to ischemic, or oxygen deprived muscle caused by cardiovascular or peripheral vascular disease. In this way, Corautus seeks to treat a cause of the underlying condition rather than the symptoms of the disease. The Company, through its wholly owned subsidiary, Vascular Genetics Inc., holds a worldwide license from Human Genome Sciences, Inc. to make, use and sell products utilizing its VEGF-2 technology, including VEGF-2 in a plasmid deoxyribonucleic acid (DNA), in the field of gene therapy for the treatment of vascular disease and diabetic neuropathy. Vascular Genetics also holds licenses from Caritas St. Elizabeth's, Vical Incorporated and Boston Scientific Corporation relating to gene therapy delivery methods and the use of DNA to induce a therapeutic effect. Corautus also has entered into a collaboration agreement with Boston Scientific Corporation to utilize Boston Scientific's Stilettoendocardial direct injection catheter system to deliver the VEGF-2 plasmid DNA directly to the affected cardiac muscle in clinical trials. The Company's lead VEGF-2 product candidate is being developed for the treatment of severe angina. The GENASIS Phase IIb clinical trial is a 404-patient study designed to evaluate the safety and efficacy of VEGF-2 delivered by catheter directly into the ischemic tissue of the heart. The United States Food and Drug Administration (FDA) has granted Fast Track designation for this VEGF-2 program for severe angina. As part of its collaboration with Boston Scientific, Corautus uses the Stiletto catheter to deliver the VEGF-2 product candidate. In January 2006, an independent data monitoring committee recommended continuation of the GENASIS trial after completing its third and final scheduled safety review of the first 240 patients. However, on March 14, 2006, Corautus temporarily suspended patient treatment in the GENASIS trial. This action was taken at the request of Boston Scientific as a result of three reported serious adverse events. The Company has notified the FDA of its voluntary suspension, and in response the FDA has placed the trial on clinical hold. On January 6, 2006, Corautus entered into a material transfer agreement with Caritas St. Elizabeth's Medical Center of Boston, Inc. in connection with its clinical trial to evaluate the safety and efficacy of VEGF-2 for the treatment of patients suffering with moderate or high-risk critical limb ischemia. Under the agreement, the Company will provide VEGF-2 for evaluation in the 64-patient Phase I trial for the treatment of critical limb ischemia. Caritas St. Elizabeth's is the sponsor of this clinical trial, which is being conducted under a funding grant from the National Institutes of Health. Corautus has the right to utilize and reference the Caritas St. Elizabeth's clinical trial data as part of its own clinical and commercialization program.

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As Of: 10/07 00:00 ET
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