CardioVascular BioTherapeutics Completes Phase I Wound Healing TrialLAS VEGAS--(BUSINESS WIRE)--Oct 2, 2007 - CardioVascular BioTherapeutics, Inc. (OTCBB: CVBT) today announced the completion of its Phase I wound healing clinical trial aimed at evaluating the safety and tolerability of the company's protein-based drug candidate (CVBT-141B), formulated with human fibroblast growth factor -1 (FGF-1), in patients suffering from either diabetic or venous stasis ulcers. FGF-1 was applied topically in 8 subjects at a single site and was found to be well tolerated.
According to the American College of Foot and Ankle Surgeons, 15 percent of the estimated 20 million Americans afflicted with diabetes will develop a serious foot ulcer during their lifetime. A similar percentage of patients with chronic venous hypertension will also develop wounds. Non-healing dermal ulcers of the lower extremities can lead to infections and amputations. Chronic wounds represent an increasing global health challenge, yet there are currently no universally-accepted standards of care.
FGF-1 offers the possibility of improved dermal ulcer healing by the promotion of new blood vessel growth, known as angiogenesis, in the wound bed resulting in enhanced development of granulation tissue and is able to fill wounds of almost any size. According to the American Diabetes Association, comprehensive foot care programs can reduce amputation rates by 45 to 85 percent.
Dr. Jack Jacobs, CVBT's Chief Operating and Scientific Officer, commented, "We are very pleased to be through our Phase I trial and to see that no serious adverse events were noted in any of the patients receiving FGF-1 topically. With the successful completion of this Phase I study the company can now move on to establish the efficacy of our drug candidate, and in this regard, we are currently finalizing a clinical study protocol for initiating a multiple dose safety and efficacy trial in an expanded patient population." Pre-clinical studies showed that FGF-1 significantly reduced the healing time of full-thickness dermal wounds in normal healthy rats and mice and showed an even greater acceleration of dermal healing in diabetic mice.
The principal investigator for the Phase I study was Thomas Serena, M.D., President of the Newbridge Medical Research Group, a research group specializing in wound healing and vascular surgery, with clinics serving several areas within Western Pennsylvania.
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with human FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has three clinical trials underway with drug candidates to treat the following medical indications: severe Coronary Heart Disease (CVBT-141H), dermal wound healing in diabetics (CVBT-141B), and Peripheral Arterial Disease (CVBT-141C).
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
Posted: October 2007