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CardioVascular BioTherapeutics Completes Phase I Wound Healing Trial

2/10/2007 - 11:55
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    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.

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