CardioVascular BioTherapeutics Submits FDA Application for 'Fast Track' Status for CVBT-141B, CVBT's Biological Treatment for Diabetes Patients
LAS VEGAS, Feb. 3, 2011 /PRNewswire/ -- CardioVascular BioTherapeutics, Inc. (Pink Sheets: CVBT) today announced it has submitted an application to the U.S. 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 Centers 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(i). 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(ii). Ischemic diabetic wounds are the most difficult of to heal. This is a life-threatening health problem for which there