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

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