CardioVascular BioTherapeutics (CVBT) has submitted an application to the FDA to obtain "fast track" designation for CVBT-141B, its biological therapy to treat ischemic diabetic wounds based on the active ingredient fibroblast growth factor-1 (FGF-1).
The FDA grants fast track designation to accelerate the development of new therapies that treat a serious medical condition and for which there are no available therapies that adequately address the problem.
Las Vegas-based CVBT said its therapy meets FDA's criteria, as ischemic diabetic wounds, if not treated, can lead to infection, sepsis, amputation and death. Even with currently-available treatments, there are more than 80,000 foot amputations per year in the diabetic patient population. On Jan. 4, CVBT released summarized results of the phase II trials.
Subject to FDA approval, the company anticipates commencement of the phase III trial for CVBT-141B in 2011.