Texas Heart Institute at St. Luke’s Episcopal Hospital
First in Southwest to Use Gene-Based Treatment for Severe Angina

HOUSTON (September 15, 2005) – Interventional cardiologist Emerson Perin, M.D., Ph.D., was the first physician in the Southwest to treat a patient for severe angina with an experimental gene-based therapy. The Texas Heart Institute at St. Luke’s Episcopal Hospital is participating in the GENASIS clinical trial, a Phase IIb study to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for treating Class III or IV angina, the most severe forms of the condition. Angina is chest pain that results from coronary artery disease in which there is reduced blood flow and inadequate oxygen supply to the heart. Each year in the U.S., more than 150,000 patients are diagnosed with severe angina, which is resistant to conventional cardiovascular treatments.

VEGF-2 is a growth factor that is believed to promote angiogenesis, the development of supplemental blood vessels to enhance blood flow to the heart. Corautus Genetics Inc. has licensed a proprietary therapeutic VEGF-2 that uses a naked plasmid – rather than a virus – as a vector to deliver the DNA for VEGF-2. A plasmid is a non-replicating circular strand of DNA that causes the expression of the VEGF-2 protein in damaged heart muscle.

“The use of a plasmid to deliver this therapeutic agent removes the potential complications associated with gene transfer using viral vectors. There’s no fever, infection or chance of rejection,” explained Dr. Perin, director of New Cardiovascular Interventional Technology at the Texas Heart Institute at St. Luke’s. “In this study we’re using an investigational device, a catheter made by Boston Scientific, to reach the heart through a small access site in the groin. We use the same catheter to inject the VEGF-2 therapeutic agent directly into damaged heart muscle.”

The Corautus agent is designed to produce a short-term expression of the VEGF-2 protein. The protein expression begins shortly after the plasmid enters a cell and continues about two weeks. VEGF-2 stimulates the production of the protein in surrounding cells, creating an efficient protein production process. The plasmid is discarded from the cell and can be broken down rapidly in circulating blood.

Earlier clinical trials have shown no gene-associated adverse side effects or toxicity. In the Phase I trial of VEGF-2, 70% of patients who received the treatment experienced an improvement in angina class of two or more levels and 30% experienced complete elimination of angina. Exercise tolerance was significantly improved in all dose groups. The subsequent Phase I/IIa trial demonstrated improved exercise tolerance and significant decrease in angina class in 50% of patients who received a high dose of the therapeutic agent.

“The patients we’re treating in this study are extremely limited and sometimes incapacitated by the discomfort of angina. They have few or no other remaining options. We are anticipating that the positive results seen in previous trials will be confirmed as we explore the safety and efficacy of the defined doses in this current study,” said Dr. Perin.

The current Phase IIb study is underway at 32 heart centers across the nation. More than 400 patients will be enrolled in the clinical trial, which physicians hope to complete by the end of the year. To get more information about the study or to be considered for enrollment in the trial, call 1-877-9ANGINA.

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World-renowned cardiovascular surgeon Denton A. Cooley, MD, founded the Texas Heart Institute in 1962 for the study and treatment of diseases of the heart and blood vessels. Together with the Institute's clinical partner, St. Luke's Episcopal Hospital, it has been ranked for the past 14 years among the nation's top ten heart centers in an annual survey published by U.S.News & World Report.