Corautus Announces Positive Gene Therapy Trial Results in Severe Angina

Corautus Genetics has announced the publication of the two-year follow-up results of 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 nonviral delivery vector) was delivered in defined doses by direct injection into the heart muscle. Results of the follow-up study, as reported in the Journal of Interventional Cardiology, demonstrate prolonged clinical benefit as measured by improvement of patients' angina two years following treatment with no reported complications directly related to the gene therapy procedure.

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 U.S.

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 Stiletto 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.