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CardioVascular BioTherapeutics, Inc. Announces Initiation of Clinical Studies to Treat Patients With Chronic Back Pain

Posted on: Wednesday, 26 April 2006, 09:00 CDT

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) today announced that it has signed a collaborative research and development agreement with the global clinical contract research organization, bioRASI, to initiate proof of concept clinical studies in patients suffering from chronic back pain. Chronic back pain, estimated in published reports to affect 26 million Americans, has recently been linked to blockage of blood vessels supplying the lower back, leading to a condition referred to as lumbar ischemia. The patients will receive CVBT's new drug candidate for lumbar ischemia which has Cardio Vascu-Grow(TM) as its active ingredient. The multi-site clinical study will be performed in Russia and Eastern Europe and will enroll patients who have proven blockages in their lumbar arteries which leads to poor perfusion and chronic pain in their lower backs.

Thomas J. Stegmann, M.D., co-founder and Chief Clinical Officer of CVBT stated, "Our new clinical collaboration with bioRASI in patients with blocked lumbar arteries is a natural extension of our ongoing clinical trials with no-option heart patients, who are receiving our drug candidate for advanced atherosclerotic disease of their coronary arteries. In Russia, we will be able to rapidly assess the potential efficacy of our drug candidate in this medical indication more economically than performing similar clinical trials in the United States. Cardiovascular disease results from a lack of proper blood perfusion and affects millions of patients. Whether it is coronary heart disease, vascular consequences of diabetes, stroke, or intestinal ischemia, it is becoming accepted now by the medical community that if you can increase blood flow to the affected tissues the patients' condition should improve. We want to find out if Cardio Vascu-Grow(TM) can accomplish this in patients with chronic back pain caused by blocked lumbar arteries."

CVBT is a biopharmaceutical company developing drug candidates with Cardio Vascu-Grow(TM) as their active ingredient for a number of diseases characterized by inadequate blood flow to a tissue or organ. Currently, the company is conducting two FDA-authorized clinical trials: one in the area of coronary artery disease in no-option heart patients, and one in the area of impaired wound healing seen in diabetics. Additionally, the company has completed pre-clinical studies in animal models of peripheral vascular disease of the legs and stroke recovery. Clinical trials in these two indications are planned to begin later this year.

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 our expectations for new research, our progress with clinical trials or our future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of our drug candidates, market acceptance of CardioVascular BioTherapeutics, Inc. 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.

Cardio Vascu-Grow(TM) is a trademark of CardioVascular BioTherapeutics, Inc.

Source: Business Wire

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