SAN DIEGO, June 11 /PRNewswire-FirstCall/ -- Cardium Therapeutics (Amex: CXM) today announced the launch of a new website at http://www.anginaresearchstudy.com to provide patients, caregivers and physicians with information about the Company's Phase 3 AWARE clinical study. The AWARE study is evaluating the therapeutic effects of Generx(TM) for the potential treatment of myocardial ischemia (insufficient blood flow within the heart muscle) and associated angina due to coronary heart disease. Generx is designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, following a one-time intracoronary infusion from a standard cardiac infusion catheter.
The AWARE (Angiogenesis in Women with Angina pectoris who are not
candidates for Revascularization) study, a Phase 3 randomized,
placebo-controlled, double-blind trial, is planned to enroll approximately
300 women with recurrent stable angina pectoris who are not candidates for
revascularization and who are receiving optimal drug therapy. The primary
endpoint is 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 are improvement in
myocardial blood flow within the affected heart muscle measured by
adenosine SPECT imaging, as well as improvements in other measures of
angina. The AWARE study is expected to include up to 50 U.S. clinical
centers. Enrollment criteria, participating sites and other info
|SOURCE Cardium Therapeutics|
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