VEGF-2 gets Fast Track Designation for theTreatment of Severe Angina
Nov 4, 2005 - 3:59:00 PM
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"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."
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By Corautus Genetics Inc.,
[RxPG] 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.
Publication:
United States Food and Drug Administration
On the web:
www.corautus.com 
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Additional information about the news article
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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 currently developing and testing a gene transfer product using the VEGF-2 gene to promote therapeutic angiogenesis in ischemic muscle. In July 2003 Corautus entered into 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.
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 projections about our ongoing clinical trial, including its cost, statements about and potential benefits from FDA Fast Track designation, projections about our future results of operations or our financial condition, benefits from the alliance with Boston Scientific, benefits from manufacturing agreements, research, development and commercialization of our product candidates, sufficient and timely enrollment of suitable patients in our clinical trial, whether early-stage clinical trial results are any indication of results in subsequent clinical trials, 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' Annual Report on Form 10-K for 2004 filed on March 22, 2005, which are incorporated by reference into this press release. All forward-looking statements included in this press release are based on information available to Corautus on the date hereof, and Corautus assumes no obligation to update such forward-looking statements.
CONTACT:
Michael K. Steele of Corautus Genetics Inc.,
+1-404-526-6212, or;
or
Kim Golodetz,
+1-212-838-3777, or,
or
Bruce Voss,
+1-212-838-3777, or ,
both of
Lippert-Heilshorn & Associates
[email protected]
[email protected] [email protected]
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