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CVBT Announces Positive Pre-Clinical Results for Protein-Based Drug Candidate to Treat Osteoporosis
Business Wire, July 17, 2007
LAS VEGAS -- CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) today announced that it has successfully completed work on a new medical indication for its protein drug candidate, human fibroblast growth factor (FGF-1), in an animal model of bone growth. In this research project, conducted in collaboration with Michael Rosenblatt, M.D., of Tufts University Medical School, the effect of FGF-1 to stimulate new bone formation was examined and compared to human parathyroid hormone, a known stimulator of bone formation in humans. As shown in the Figure below, FGF-1 was almost 20-fold more potent, on a weight basis, than parathyroid hormone (PTH) in stimulating bone formation in mice.
Current marketed therapies for osteoporosis, including the bisphosphonates of which Merck's Fosamax is a member, primarily act by inhibiting the breakdown of bone in osteoporosis, but do not stimulate new bone formation. The promise of a bone growth factor, such as FGF-1, which reverses bone degeneration by adding back lost bone, would be a significant advancement in the treatment of this debilitating disorder.
The completion of this research marks the initiation of a new initiative by CVBT to develop FGF-1 as a new treatment for osteoporosis. Dr. Rosenblatt, an internationally-recognized expert in the field of bone biology and calcium-regulating hormones, will continue to collaborate on this initiative. Dr. Rosenblatt is currently dean of Tufts University Medical School in Boston, MA, and previously served as vice president of world-wide research at Merck & Co. where he led the research and development efforts that culminated with the FDA approval of Fosamax for the treatment of osteoporosis in 1993.
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-141A), 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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