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.
