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UPMC Cardiovascular Institute Participating in Study of Angiogenic Gene Therapy for Coronary Artery Disease

PITTSBURGH, January 7, 2003 Clinicians at the University of Pittsburgh Medical Centers (UPMC) Cardiovascular Institute have begun a Phase IIb/III clinical research study of angiogenic gene therapy for patients with stable exertional angina due to coronary artery disease. The purpose of the study is to assess whether gene transfer can be safely administered and whether it can stimulate the growth of new blood vessels in the heart and benefit participants with angina.

The randomized, double blind, placebo-controlled study will evaluate the efficacy of a protein known as fibroblast growth factor, Ad5FGF-4, versus placebo.

Angina is chest pain that results when the heart does not receive enough blood. It may be a feeling of tightness, heaviness, dull discomfort, numbness, burning, pressure or crushing pain that is usually felt behind the breastbone. It can also spread to the arms, neck and jaw.

Researchers are studying angiogenic gene therapy as a potential option to stimulate angiogenesis, an important natural process in the human body, by supplementing the heart with angiogenic growth factor protein. This may help provide alternate routes for oxygenated blood to flow around narrow or blocked arteries due to atherosclerosis.

"Angiogenic gene therapy with Ad5FGF-4 is an innovative approach that could potentially transform how coronary artery disease is managed," said Joon S. Lee, M.D., assistant professor of medicine at the University of Pittsburgh School of Medicine, director of Interventional Cardiology, associate director of Cardiac Catheterization Laboratories and principal investigator in the Pittsburgh arm of the study.

By effectively stimulating angiogenesis, the bodys natural ability to grow new blood vessels, angiogenic gene therapy has the potential to provide an additional treatment option to the most common treatments for coronary artery disease, such as angioplasty, bypass surgery and medication.

In the study, patients will randomly receive either Ad5FGF-4 or a placebo through a one-time intracoronary injection during heart catheterization. If Ad5FGF-4 is injected, angiogenic genes are transported by a modified version of a common cold virus (adenovirus) through arteries and capillaries directly to the heart muscle.

Risks associated with angiogenic gene therapy may be related to the route of administration (e.g., bleeding or inflammation), the vector (e.g., inflammation), or the growth-factor protein (e.g., unwanted growth in existing tumors in other areas of the body).

In the initial studies of Ad5FGF-4, side effects that were commonly seen, occurring in about 1-25% of the patients (1-25 out of 100 patients), include transient fever (temporally associated with product administration and confined to the highest dose group), and transient and modest increases in liver enzymes. These were not associated with liver symptoms or bilirubin elevation.

If gene transfer occurs, angiogenic growth factor proteins may be produced, stimulating angiogenesis. Newly created blood vessels then may provide alternate paths for oxygen-rich blood to flow around narrowed or blocked arteries due to atherosclerosis.

Coronary artery disease, primarily caused by atherosclerosis, affects nearly 14.5 million Americans. It is the leading cause of death in industrialized nations and claims the lives of nearly 500,000 people in the United States annually. Each year, approximately 400,000 coronary angioplasties and 500,000 coronary artery bypass surgeries are performed to provide relief from advanced atherosclerosis.

UPMC is among an estimated 100 centers nationwide participating in the trial. A total of 450 participants will be enrolled nationwide with about 15 enrolled at UPMC. Participants will range in age from 30-75 years.

Prospective participants can call 412-647-6136 for more information about eligibility.

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