FDA grants fast track designation to Cardium heart therapy

The condition is characterized by insufficient blood flow within the heart muscle, which gives rise to angina associated with coronary heart disease.

Generx represents a new therapeutic class of biologics designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, following a one-time intracoronary administration from a standard cardiac infusion catheter.

The fast track program is designed to facilitate the development and expedite the review of new drug and biologic products that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Fast track designation allows a company to submit portions of a biologic license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA prior to receiving the complete application. In addition, fast track designation ordinarily allows the opportunity for increased interactions with the FDA and the potential for priority 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,” stated Christopher J. Reinhard, chairman and CEO of Cardium. “This represents a significant regulatory milestone in the development of Generx, and further underscores its potential to promote a disease-modifying improvement based on therapeutic angiogenesis in patients with coronary heart disease.”

The granting of fast track designation by the FDA follows the conclusion of four clinical studies of Generx, which to date have involved more than 650 patients with coronary heart disease.