Cardium testing heart drug in women

SAN DIEGO, May 16 (UPI) -- U.S. firm Cardium said Wednesday it has begun its phase 3 AWARE study of the DNA-based drug Generx for myocardial ischemia, a marker of heart disease.

The company said it would enroll about 300 women with stable angina in the placebo-controlled AWARE study (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) at as many as 50 U.S. centers.

The study will assess the time to onset of electrocardiogram changes indicating myocardial ischemia during exercise treadmill testing at six months following administration, and will also measure improvement in the patients' myocardial blood flow within the affected heart muscle, and other improvements in angina.

Cardium said Generx works by promoting angiogenesis, or blood-vessel growth within the heart muscle, adding it is the first DNA-based heart therapy to advance to phase 3 trials.

It is also the only drug in phase 3 to treat stable angina, a condition affecting millions worldwide, Cardium said.

Myocardial ischemia is marked by insufficient blood flow within the heart muscle, causing angina associated with coronary heart disease.