CARDIOVASCULAR BIOTHERAPEUTICS AUTHORIZED TO START PHASE I TRIAL

CardioVascular BioTherapeutics has announced that their investigational new drug application to the FDA has been allowed and the company is now authorized to commence its Phase I clinical trial in diabetic patients who have foot ulcers and/or open leg wounds. The company has chosen a clinical trial site in the Pittsburgh area that is an internationally recognized center for the treatment of wounds.

The company is planning on testing two doses of its wound healing agent, Cardio Vascu-Grow, for topical application. The principal purpose of this first study is to test the safety and tolerability of Cardio Vascu-Grow in the target patient population. Earlier animal studies in diabetic mice with experimental wounds showed that Cardio Vascu-Grow significantly improved the healing rate of the wounds when compared to control animals.