CardioVascular BioTherapeutics, Inc. 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 per cent 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 per cent of patients treated with FGF-1 had complete closure of their diabetic wounds at eight weeks, versus 0 per cent 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 per cent annually, according to MedMarket Diligence, LLC; report #S247. The annual management cost of skin ulcers is greater than $20 billion in the US alone according to Drexel University's NIR Device for Predicting Diabetic Wound Healing, 2009.

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.