CardioVascular BioTherapeutics (CVBT) announced that it has submitted an application to the FDA to obtain “fast track” designation for CVBT-141B for the treatment of ischemic diabetic wounds. Based on Phase 2 trials, diabetic wounds treated with CVBT-141B healed approximately 4.5 times faster than wounds treated with placebo/standard of care (including debridement). A second Phase 2b trial demonstrated diabetic wounds achieving 100% closure within five months or less, whereas one-third of the placebo treated wounds remained open at the end of the same treatment period. Subject to FDA approval, CVBT anticipates commencement of the Phase 3 trial for CVBT-141B in 2011.
CVBT-141B’s active ingredient, fibroblast growth factor-1 (FGF-1), is a human protein that stimulates the growth of new blood vessels, thereby increasing the blood supply to ischemic organs and tissues.
For more information call (702) 839-7200 or visit www.cvbt.com