Cedars-Sinai Heart Institute Now Enrolling Women With Recurrent Chest Pains For Aware Clinical Trial

Los Angeles - March 11, 2008 – The Cedars-Sinai Heart Institute is recruiting female patients with recurrent chest pains who are not eligible for surgery to participate in a clinical trial studying an experimental product designed to promote blood vessel growth within the heart muscle. 

The AWARE trial will study the effects of Generx™ (Ad5FGF-4) in women for the potential treatment of myocardial ischemia (insufficient blood flow within the heart muscle) which can cause chest pains (angina) associated with coronary heart disease. Generx is an investigational product designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle.

The AWARE trial is a randomized, placebo-controlled, double-blind study, that will enroll approximately 300 women with recurrent stable angina pectoris who are not candidates for revascularization and who are receiving optimal drug therapy.

The primary effect of the investigational medication will be measured during an exercise treadmill test done at baseline and again at six months. The secondary effect will be measured through the myocardial blood flow using SPECT (single photon emission computed tomography), as well as other tests for angina.

“Generx is believed to work by stimulating the growth of new microvascular blood vessels (angiogenesis) in the heart, thereby relieving myocardial ischemia and the associated chest pain, through improved blood flow,” stated Prediman K. Shah, M.D., a trial investigator and director of Cedars-Sinai’s Division of Cardiology and Atherosclerosis Research Center, as well as holder of the hospital’s Shapell and Webb Family Endowed Chair in Cardiology.

“Current approaches for the treatment of chronic angina include drug therapy, such as beta-blockers, calcium channel blockers, and/or long-acting nitrates and mechanical revascularization, such as angioplasty, stent, or bypass surgery. However, many patients continue to suffer from angina symptoms which impact their health and their ongoing quality of life,” said Shah.

An estimated seven million American women are currently living with coronary heart disease and over four million women suffer from angina. The American Heart Association reports that more women’s lives are claimed annually by heart disease than by the next five leading causes of death combined (all cancers, chronic obstructive pulmonary disease/COPD, Alzheimer’s, diabetes and accidents). Despite these stark statistics, surveys indicate that nearly half of women are not aware that heart disease is the leading cause of death among women, and only 20 percent identified heart disease as the greatest health problem facing women today.

Cedars-Sinai is among an estimated 50 centers nationwide participating in the AWARE trial. Prospective participants can call 1-800-CEDARS1 (1-800-233-2771) for more information about the study and eligibility.