CardioVascular BioTherapeutics Announces Diabetic Wounds Drug Phase II Clinical Trial Data

CardioVascular BioTherapeutics, Inc. (Pink Sheets: CVBT) 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