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AWARE Clinical Trial Designed for Women with Heart Disease

March 13, 2008 -- Last year in the U.S. and every year since 1984, more women than men have died of heart disease. Surprised? Most women are. An estimated seven million American women are currently living with coronary heart disease and more than four million women suffer from angina, or chest pain due to coronary heart disease.

Anginal pain may be brought on by the simplest tasks, such as getting up from a chair, taking a short walk, or even stress. These women are limited in their daily activities and often have different angina symptoms than men. Women with chronic angina are more likely to experience unusual fatigue, sleep disturbances, gastrointestinal symptoms or shortness of breath.

Over 25 hospitals across the United States are currently participating in the AWARE clinical study to evaluate the effects of Generx™ (Ad5FGF-4) in women with recurrent angina who are not candidates for revascularization and who are receiving optimal drug therapy. The AWARE study is a women-only cardiovascular clinical study and reflects a growing awareness that heart disease in women is a major health issue. For more information about the AWARE trial, log onto the trial site at ClinicalTrials.gov.

About Generx
Generx is an investigational product currently being studied for its effectiveness, compared to a placebo-control, to treat myocardial ischemia. Myocardial ischemia, which results from insufficient blood flow within the heart muscle, gives rise to the angina symptoms associated with coronary heart disease. Generx represents a new therapeutic class of biologics that may promote angiogenesis, a natural process of blood vessel growth within the heart muscle, to provide improved blood flow following a one-time intracoronary administration from a standard cardiac infusion catheter.

Angioplasty.Org recommends that women who are interested in this study contact the study investigator in their locale, using the AWARE Trial Study Locator. The investigator will be able to discuss this potential new approach to the treatment of angina.