Cardium Therapeutics: AWARE Clinical Trial

Purpose
The Phase 3 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 gives rise to 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.

Study Design
AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) is a randomized, placebo-controlled, double-blind safety and efficacy study to evaluate a one-time intracoronary administration of Generx. The AWARE study is enrolling approximately 300 women with recurrent stable angina pectoris who are not candidates for revascularization and who are receiving optimal drug therapy. Approximately 50 U.S. medical centers are expected to participate in the AWARE study.

Primary and Secondary Measures
The primary endpoint will be the improvement in time to onset of electrocardiogram changes diagnostic of myocardial ischemia during exercise treadmill testing at six months following administration. The secondary endpoints will include improvement in myocardial blood flow within the affected heart muscle measured by adenosine SPECT (single photon emission computed tomography) imaging, as well as improvements in other measures of angina.