CardioVascular BioTherapeutics, Inc. (CVBT) announced it has submitted an application to the US 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 promising new therapies that treat a serious medical condition and for which there are no available therapies that adequately address the problem.

CVBT believes CVBT-141B meets the FDA's criteria, as ischemic diabetic wounds, if not successfully 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. CVBT-141B is targeted at reducing the suffering in the diabetes community by closing ischemic diabetic wounds much more rapidly, thereby halting the all-too-common progression to infection, gangrene, amputation, and death.

CVBT's CEO, Daniel C. Montano, stated, “This is a major development for CVBT's ischemic diabetic wound healing program as well as for diabetes patients. The Centres for Disease Control and Prevention (CDC) reports that approximately 26 million Americans suffer from diabetes, while published peer-reviewed statistics indicate that 15% to 25% of these patients (3.9 million to 6.5 million patients) will eventually develop a diabetic foot wound at some point in their lifetime.

Further, additional published peer-reviewed statistics indicate that in any given year, between 2% and 5% of diabetes patients (520,000 to 1.3 million patients annually) will develop one of these wounds. Ischemic diabetic wounds are the most difficult of to heal. This is a life-threatening health problem for which there is urgent need for more effective treatments.”

On January 4, 2011, CVBT released summarized results of the phase II trials. In the phase II a trial, diabetic wounds treated with FGF-1 healed approximately 4.5 times faster than wounds treated with placebo/standard of care (which included debridement). In the phase II b trial, all of the diabetic wounds treated with FGF-1 achieved 100% closure within five months or less, whereas a full one-third of the placebo-treated wounds remained open at the end of the same treatment period.

Additionally, 57% of patients treated with FGF-1 had complete closure of their diabetic wounds at eight weeks, versus 0% for the placebo group. Both phase II trials demonstrated statistical significance to placebo (p<0.05).  In all trials (phase I and phase II), there have been no significant safety or adverse events attributable to the drug. Subject to FDA approval, CVBT anticipates commencement of the phase III trial for CVBT-141B in 2011.

CVBT is a biopharmaceutical company developing drug candidates with FGF-1 as its Active Pharmaceutical Ingredient (API) for diseases characterized by inadequate blood flow to tissue or organs. The company has a phase II trial to treat severe coronary heart disease (CVBT-141H) underway, and has received FDA authorization for a Phase I trial to treat peripheral arterial disease (CVBT-141C). A phase III trial to treat diabetic wounds (CVBT-141B) is planned pending FDA approval.