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Corautus Genetics' Phase IIb Clinical Trial for Severe Angina Treatment Receives Go-Ahead From Data Monitoring Committee Based on Second Interim Safety Data Review

Posted on: Thursday, 4 August 2005, 09:00 CDT

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. announced today that the independent data monitoring committee (DMC) recommended, as the result of its second 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 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 115 patients were treated in the trial. This was the second positive interim safety analysis recommendation by the DMC. The DMC, a group of independent physicians and a statistician, was established to monitor the safety data from the trial. Based upon their review of the available data, the DMC recommended continuing 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 the heart via Boston Scientific Corporations' Stiletto(TM) catheter system. Corautus developed a well-defined schedule to deliver data for the first two interim safety analyses to the independent DMC and we anticipate the third DMC analysis and review after approximately 250 patients are treated. There is an important unmet medical need to help patients suffering from severe angina where traditional methods have been unsuccessful, and we are working diligently to conduct our trial in the safest and most efficient manner possible to help these patients. As such, we are pleased with the recommendation of the DMC to continue the trial."

The American Heart Association estimates that more than 6.4 million individuals in the United States are classified as having angina pectoris. Of these individuals with angina pectoris, approximately 150,000 to 250,000 annually are diagnosed as having refractory coronary artery disease and cannot be successfully treated with conventional cardiovascular therapies.

About the GENASIS Trial

GENASIS is a randomized, double-blinded, 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. Completion of enrollment is expected in the first quarter of 2006.

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 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 stimulates 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.

Corautus Genetics Inc.

CONTACT: Michael K. Steele of Corautus Genetics Inc., +1-404-526-6212,or msteele@corautus.com , or Kim Golodetz, +1-212-838-3777, orkgolodetz@lhai.com , or Bruce Voss, +1-310-691-7100, or bvoss@lhai.com , bothof Lippert/Heilshorn & Associates

Web site: http://www.corautus.com/

Source: PRNewswire-FirstCall

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