VEGF Corautus Genetics (MM)

ATLANTA, Jan. 26 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (NASDAQ:VEGF) announced today that its data safety monitoring committee (DMC) recommended, as the result of its third and final scheduled interim safety analysis, the continuation of GENASIS ("Genetic Angiogenic Stimulation Investigational Study"). GENASIS is Corautus' Phase IIb clinical trial to evaluate the safety and efficacy of its proprietary Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of patients with severe angina. This planned interim safety analysis was conducted after the first 240 patients were treated in the trial. This was the third positive interim safety analysis recommendation by the DMC. The DMC, a group of independent physicians and a statistician, was established by Corautus to monitor patient safety in the trial. Based upon their review of the available safety database for both the therapeutic and delivery device, the DMC recommended that Corautus continue the GENASIS trial. Richard E. Otto, President and CEO of Corautus, stated, "The GENASIS trial is designed to test the efficacy and safety of VEGF-2, delivered into ischemic areas within the heart via Boston Scientific Corporations' Stiletto(TM) catheter system. This completes the third and last interim safety analyses by the independent DMC that we established. We have been very pleased to have successfully passed all three safety reviews and we are pleased with the recommendation of the DMC to continue the trial." About the GENASIS Trial GENASIS is a randomized, double-blind, dose-ranging and placebo controlled Phase IIb clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial is being conducted in approximately 30 leading cardiac medical centers throughout the United States. In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific Corporation (NYSE:BSX) Stiletto(TM) endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac catheterization laboratory. VEGF-2 is a naturally occurring growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. Once administered, the DNA plasmid appears to be taken up and expressed by myocardium near the injection site. Inside the cell, the DNA plasmid then enters the nucleus of the cell without a requirement of incorporation into the genomic DNA. The Phase IIb clinical trial expects to see the effect of the expression of DNA-encoded VEGF-2, which in turn is believed to stimulate the growth of new blood vessels by promoting the migration and proliferation of endothelial cells in the heart. About Corautus Genetics Inc. Corautus Genetics Inc. is a clinical-stage biopharmaceutical company dedicated to the development of gene transfer therapy products for the treatment of cardiovascular (severe angina) and peripheral vascular disease. Corautus is currently developing and testing a gene transfer product using the Vascular Endothelial Growth Factor-2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic muscle. For more information, please visit http://www.corautus.com/. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. These risks include statements which address operating performance, events or developments that we expect or anticipate will occur in the future, such as reviews of data by the Data Monitoring Committee, projections about our ongoing clinical trial, including its costs, potential benefits from manufacturing agreements, the potential benefits from previous clinical trials, sufficient and timely enrollment of suitable patients in our clinical trial, future results of operations or our financial condition, adequacy of funding, benefits from the alliance with Boston Scientific, research, development and commercialization of our product candidates, anticipated trends in our business, manufacture of sufficient and acceptable quantities of our proposed products, approval of our product candidates, meeting additional capital requirements, and other risks that could cause actual results to differ materially. These risks are discussed in Corautus Genetics Inc.'s Securities and Exchange Commission filings, including, but not limited to, the risk factors in Corautus' 2004 Annual Report on Form 10-K which was filed on March 22, 2005, which are incorporated by reference into this press release. First Call Analyst: FCMN Contact: jcallicutt@corautus.com Web site: http://www.corautus.com DATASOURCE: Corautus Genetics Inc. CONTACT: Michael K. Steele of Corautus Genetics Inc., +1-404-526-6212, or ; or Kim Golodetz, +1-212-838-3777, or , or Bruce Voss, +1-310-691-7100, or , both of Lippert-Heilshorn & Associates for Corautus Genetics Inc.

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