PITTSBURGH, April 3, 1998 — Cardiologists at the University of Pittsburgh Medical Center (UPMC) are beginning a clinical trial of a gene therapy treatment to stimulate the growth of new blood vessels to increase the supply of blood to the heart. These newly formed vessels will provide an alternate route for blood to bypass clogged and blocked arteries in the heart. The process is called angiogenic gene therapy and selectively delivers human fibroblast growth factor(FGF) genes into the hearts of patients.
"This represents a fundamentally new and different way of treating coronary artery disease," said Joon Sup Lee, M.D., assistant professor of medicine in the division of cardiology at the UPMC and principal investigator in the study. "The treatment may eventually help angina patients who have exhausted other means of heart revascularization such as angioplasty and bypass surgery.
"The patients who would benefit most from the treatment are those who are not candidates for conventional angioplasty or bypass surgery. They may have small, completely blocked or narrowed vessels which make them unsuitable for conventional therapy but good for angiogenesis."
The UPMC is one of 10 centers participating in the phase I/II trial. A total of 60 patients nationwide will be treated, about 10 at UPMC. Patients will range in age from 50 to 75 years.
In the treatment, a catheter is inserted into the femoral artery and then threaded into the coronary arteries where the FGF gene, by way of a human adenovirus-5 vector, is delivered.
The vector used for this gene therapy, the human adenovirus, which is responsible for a short-lived cold, is modified so that it will not produce an infection. The genetically engineered virus is carried into the heart muscle where it produces specific proteins that initiate growth of new collateral blood vessels. The process is designed to enhance the heart’s natural healing process by providing an additional stimulus to promote angiogenesis.
"Based on pre-clinical studies, we would hope to see the development of collateral blood vessels within two to four weeks," Dr. Lee said. "We will use a treadmill exercise test, a stress echocardiogram and other standard evaluation methods after four weeks and then again after eight weeks to determine any functional improvements in the patients."
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 U.S. annually. Each year, approximately 400,000 coronary angioplasties and 500,000 coronary artery bypass surgeries are performed to provide relief from advanced atherosclerosis.
FGF is manufactured by Collateral Therapeutics, a San Diego-based biotechnology company focused on the discovery, development and commercialization of novel and innovative gene therapy products for the treatment of cardiovascular disease.
Please visit University of Pittsburgh Medical Center's Cardiovascular Institute website for more information on cardiology services and programs.