Healthcare Industry News:  gene therapy  

Biopharmaceuticals Cardiology FDA

 News Release - July 13, 2006

Corautus Genetics Announces Partial Lifting of FDA Clinical Hold and Update on GENASIS Database Lock

ATLANTA, July 13 (HSMN NewsFeed) -- Corautus Genetics Inc. (Nasdaq: VEGF ), a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") has recently lifted the clinical hold imposed March 29, 2006 on its GENASIS Phase IIb clinical trial for the treatment of cardiovascular (severe angina) disease. Additionally, Corautus announced plans for locking the GENASIS clinical trial database and conducting analyses of the data for efficacy endpoints and safety information.



Corautus recently received notification from the FDA that the company has satisfactorily addressed the majority of the issues raised in the March 29, 2006 clinical hold letter and that the clinical hold on the GENASIS trial has been lifted. The Investigational New Drug Application ("IND") will remain on a "partial hold," as Corautus expected, until the remaining issues in the letter, all of which are associated with results of certain tests related to the delivery catheter system and injection procedure, are completed. Corautus expects to submit the results of those tests and the efficacy and safety analyses from the GENASIS clinical trial to the FDA for review later this year.

Corautus ceased enrolling patients in the GENASIS trial on March 14, 2006, but it has continued to gather follow-up data on treated patients. Corautus will lock the database on August 14, 2006 for the 295 patients treated in the GENASIS clinical trial. The efficacy and safety analyses to be performed on the database will include 295 patients at 3 months, 241 patients at 6 months and 103 patients at 12 months. Corautus expects to present the results from the trial in the fall of 2006.

Richard E. Otto, President and Chief Executive Officer of Corautus, said, "A major clinical and regulatory focus for the past few months has been to successfully respond to the issues raised by the FDA in the clinical hold letter of March 29, 2006. We are pleased with the FDA's decision to lift the clinical hold on the GENASIS trial, and we will work with personnel from Boston Scientific Corporation to complete the additional testing requested by the FDA. We continue to have active dialogue with the FDA regarding our development plans."

Mr. Otto continued, "More recently our clinical focus has been on obtaining follow-up data on all of the 295 patients treated in the trial. Our decision to lock the GENASIS clinical database will allow comprehensive analyses and review of patient data for efficacy endpoints and safety information."

About Corautus Genetics

Corautus Genetics 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 developing a gene therapy product candidate using the VEGF-2 gene to promote therapeutic angiogenesis in ischemic muscle. Corautus has a strategic alliance with Boston Scientific Corporation to develop, commercialize and distribute the VEGF-2 gene therapy products. For more information, please visit www.corautus.com.

About GENASIS

GENASIS is a randomized, double-blind, dose-ranging and placebo controlled Phase IIb clinical trial, originally planned to enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial has been 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, were delivered to diseased heart muscle tissue via the Boston Scientific Corporation (NYSE: BSX ) Stiletto(TM) endocardial direct injection catheter system. The injection procedure was 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 was designed to determine 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.

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 that address operating performance, events or developments that we expect or anticipate will occur in the future, such as projections about our GENASIS clinical trial or any future trials, including the likelihood of obtaining positive data from such trials, potential benefits from manufacturing agreements, the potential benefits from previous clinical trials, potential benefits from Phase I trials we are supporting in the areas of critical limb ischemia and diabetic neuropathy, future results of operations or our financial condition, adequacy of funding, benefits from the alliance with Boston Scientific, including any benefits to be derived from converting debt into equity, 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' 2005 Annual Report on Form 10-K which was filed on March 20, 2006 amended by Corautus' Form 10-Q for the period ended March 31, 2006 which was filed on May 15, 2006. All forward-looking statements included in this document are based on information available to Corautus on the date hereof, and Corautus assumes no obligation to update any such forward-looking statements.


Source: Corautus Genetics

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