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news.CardioVascular BioTherapeutics (CVBT) has successfully closed an exclusive licensing agreement with an affiliate of Merck & Co for clinical and scientific data concerning the therapeutic use of use of human fibroblast growth factor-1 (FGF-1) for the treatment of diabetic wounds, along with the Phase IIa and IIb data.
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CVBT is planning to use the data in conjunction with its CVBT’s own data, and apply to the FDA to commence a Phase III pivotal trial of CVBT-141B, its diabetic wound healing drug candidate.
If approved by the FDA, the Phase III trial is estimated to begin in 2011.
Due to the diabetic patients’ unmet medical need for healing of open wounds, which have a high risk of infection, CVBT will be applying for Fast Track Development Program with the FDA status for CVBT-141B.
CVBT CEO Daniel Montano said the Phase II clinical data, in conjunction with additional unpublished pre-clinical data CVBT obtained in the licensing agreement, clearly support the company’s belief that CVBT-141B is a promising wound-healing drug candidate.
"While CVBT is presently focused on seeking accelerated approval of CVBT-141B for diabetic wounds, CVBT is also planning to expand the use of this drug candidate to other wound healing indications including venous stasis ulcers, surgical wounds, and burns," Montano said.