CardioVascular BioTherapeutics Announces Diabetic Wounds Drug Phase II Clinical Trial Data

LAS VEGAS, Jan. 4, 2011 /PRNewswire/ -- CardioVascular BioTherapeutics, Inc. (Pink Sheets: CVBT) today released summary Phase IIa and Phase IIb clinical trial data for CVBT's biological therapy to treat diabetic wounds, CVBT-141B. CVBT's Phase II data indicates that CVBT's FGF-1 biological drug appears to be delivering efficacy at a level significantly greater than has been seen in any other treatments, for patients suffering from chronic ischemic diabetic wounds.

The results of the two randomized, double-blind, placebo-controlled Phase II trials are summarized as follows: In the Phase IIa 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 IIb 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.

CVBT's CEO, Daniel C. Montano, stated: "This is extremely significant medical treatment news for diabetes patients, because CVBT-141B appears to be delivering a major treatment breakthrough for the treatment of chronic ischemic diabetic wounds. There is currently great medical need to more effectively treat diabetic wounds, to more rapidly close the wounds and avoid infections that all too often lead to amputations and worse. Current treatment options do not work for a large percentage of diabetes patients. With this Phase I and Phase II clinical trial data, CVBT plans to request FDA approval to commence a pivotal Phase III trial for CVBT-141B. Additionally, CVBT plans to apply for 'Fast Track Development Program' status for CVBT-141B."

There are 13.5 million diabetic ulcers globally, and the incidence is growing at nearly 10% annually, according to MedMarket Diligence, LLC; report #S247. The annual management cost of skin ulcers is greater than $20 billion in the U.S. alone according to Drexel University's NIR Device for Predicting Diabetic Wound Healing, 2009.

About CardioVascular BioTherapeutics

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). CVBT initiated its diabetic wound healing program in 2004, and completed an FDA-authorized Phase I study in diabetic patients in 2008. In the Phase I study, CVBT demonstrated that FGF-1 was well tolerated and showed no adverse effects when applied topically to diabetic wounds. To accelerate CVBT's wound healing program, the company recently completed a licensing agreement to obtain pre-clinical and clinical trial data for FGF-1 in dermal wound healing indications, including human data from Phase IIa and Phase IIb FDA clinical trials. A Phase III trial to treat diabetic wounds (CVBT-141B) is planned, pending FDA approval.