Cardium's cardiac gene drug on fast track

SAN DIEGO, July 18 (UPI) -- Cardium Therapeutics said Wednesday its gene therapy for heart disease has been granted fast-track status by the U.S. Food and Drug Administration.

The company is developing Generx for the treatment of myocardial ischemia, a condition where inadequate blood flow within the heart muscle causes angina associated with coronary heart disease.

Generx treats the condition by stimulating the growth of new blood vessels in the heart.

The company is currently testing the potential heart therapy in the phase 3 AWARE trial, which it said would ultimately enroll about 300 women with recurrent stable angina pectoris who are not candidates for revascularization and who are receiving optimal drug therapy.

The fast-track status for Generx means the FDA will likely complete its review of Generx within six months and allows the company to submit parts of its new drug application to the agency as they are completed to allow for faster review.

"We are pleased that the FDA has recognized the urgent and unmet medical need for effective new therapies for the treatment of patients with recurrent angina associated with heart disease," said Christopher Reinhard, chairman and chief executive officer of Cardium.