ATLANTA, Nov. 16 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. (Nasdaq: VEGF - News) announced today the publication of preclinical results of the Company's gene transfer technology administered in combination with cytokines (blood cell growth factors). In a separate project, Corautus' technology is currently being tested in a Phase IIb trial known as GENASIS ("Genetic Angiogenic Stimulation Investigational Study"), which is enrolling up to 404 patients with Class III or IV angina in approximately 20 cardiac medical centers in the United States. In the GENASIS trial, defined doses of Vascular Endothelial Growth Factor-2 (VEGF-2) in the form of naked DNA plasmid, a non- viral vector, are delivered to diseased heart muscle tissue via the Boston Scientific Corporation Stiletto(TM) endocardial direct injection catheter system.
In the preclinical study reported in the journal Circulation (Vol. 110, No. 11, pp. 1398-1405), a team of researchers under the direction of Dr. Douglas W. Losordo, Chief of Cardiovascular Research at Caritas St. Elizabeth's Medical Center in Boston, tested VEGF-2 gene transfer in combination with cytokines in animal models of chronic and acute myocardial infarction ("heart attack"). The results demonstrated that the combination approach led to improved oxygenation and increased growth of supplementary blood vessels.
In addition to his role in the preclinical research of VEGF-2, Dr. Losordo is the national principal investigator for the ongoing GENASIS trial. Dr. Losordo stated, "A key goal of our efforts in VEGF-2 therapy is to increase angiogenesis, the growth of new blood vessels, in order to compensate for blocked or occluded coronary arteries which can no longer provide enough oxygen to the heart muscle. As demonstrated in previous preclinical studies, VEGF-2 provides the original signal to recruit early precursor cells to the site of low oxygen, where they form together to create new blood vessels. We believe that the addition of cytokines can induce further mobilization of these bone marrow-derived endothelial progenitor cells, potentially aiding their recruitment or retention."
"VEGF-2 gene transfer is an approach that has already shown encouraging results in early-stage clinical tests of patients with severe coronary artery disease," said Richard E. Otto, President and CEO of Corautus. "Based on these clinical findings, we initiated in September the largest trial of its kind in gene transfer therapy in the U.S. The results being published from this latest preclinical work by Dr. Losordo and his team demonstrate the potential advantages of looking at combination therapy in addition to monotherapy with VEGF-2. In light of the reported findings in this preclinical study, we believe that adding cytokines could be a useful enhancement, and it encourages further research in this area."
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 severe cardiovascular 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. In July 2003, Corautus entered into a strategic alliance with Boston Scientific Corporation (NYSE: BSX - News) to develop, commercialize and distribute the VEGF-2 gene therapy products. For more information, please visit http://www.corautus.com .
About the Technology
VEGF-2 is a growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. In the Phase IIb trial for severe cardiovascular disease, VEGF- 2 is delivered to the ischemic tissue in the heart muscle in the form of naked DNA plasmid, a non-viral vector. 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.
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, the potential benefit from other preclinical studies, sufficient 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' Annual Report on Form 10-K for the year ended December 31, 2003 filed March 30, 2004, which are incorporated by reference into this press release.
CONTACT: Investor Relations, Jack W. Callicutt of Corautus Genetics Inc., 404-526-6200, or fax, 404-526-6218; and Media Relations, Justin Jackson of Burns McClellan, on behalf of Corautus Genetics Inc., 212-213-0006, firstname.lastname@example.org
Synergistic Effect of Bone Marrow Mobilization and Vascular Endothelial Growth Factor-2 Gene Therapy in Myocardial Ischemia
Atsuhiko Kawamoto, Toshinori Murayama, Kengo Kusano, Masaaki Ii, Tengiz Tkebuchava, Satoshi Shintani, Atsushi Iwakura, Ingrid Johnson, Patrick von Samson, Allison Hanley, Mary Gavin, Cindy Curry, Marcy Silver, Hong Ma, Marianne Kearney, and Douglas W. Losordo
Circulation 2004 110: 1398 - 1405
Message posted by: Frank S. Zollmann
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