Corautus Genetics Inc. (NASDAQ:VEGF) announced today the publication of the two year follow-up results of the Corautus’ earlier Phase I study of VEGF-2 in patients with severe angina. In this trial, Vascular Endothelial Growth Factor-2 (VEGF-2), in the form of "naked" plasmid DNA (a non-viral delivery vector) was delivered in defined doses by direct injection into the heart muscle. Results of the follow-up study, as reported by the investigators in the current issue of the Journal of Interventional Cardiology (JOIC) (Vol. 18, No. 1, pp. 27 – 31, 2005), demonstrate prolonged clinical benefit as measured by improvement of patients’ angina two years following treatment (p < 0.05) with no reported complications directly related to the gene therapy procedure. The Journal article and full publication are available on line at www.blackwellpublishing.com/joic .
Corautus’ technology is currently being tested in a randomized, double-blinded, dose-ranging and placebo-controlled Phase IIb clinical trial known as GENASIS ("Genetic Angiogenic Stimulation Investigational Study"), which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial will be conducted in approximately 25 cardiac medical centers throughout the United States. In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA 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 laboratory. Corautus expects to complete patient enrollment of the Phase IIb trial around the end of 2005.
Dr. Douglas W. Losordo, the national Principal Investigator for the GENASIS trial and Chief of Cardiovascular Research at Caritas St. Elizabeth’s Medical Center in Boston, commented, "While previous findings showed positive results, the two year follow-up of the Phase I data demonstrate that VEGF-2 therapy may be associated with prolonged clinical benefit in patients who have no other options for the treatment of severe angina. These results are cause for encouragement, and we are now conducting the largest double-blinded, placebo-controlled trial of its kind to confirm these findings."
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