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CVBT Announces Cardio Vascu-Grow Appears to Be Safe and Well Tolerated As a Treatment for Coronary Heart Disease

Posted on: Wednesday, 15 June 2005, 09:00 CDT

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) announced today that its Phase 1 clinical trial results to date have shown that CVBT's drug candidate Cardio Vascu-Grow(TM) appears to be safe and well tolerated as a treatment for Coronary Heart Disease. This study was performed under an Investigational New Drug Application filed with the FDA.

A Phase 1, multi-center, open label, dose escalation study, to evaluate the safety and tolerability of Cardio Vascu-Grow(TM) for the treatment of Coronary Heart Disease is currently ongoing at multiple centers in the United States. Patients with Coronary Heart Disease deemed not eligible for treatment by traditional interventional therapies, also known as no-option heart patients, will receive one of three doses of Cardio Vascu-Grow(TM).

Four patients in the first dosing group have been enrolled and treated with Cardio Vascu-Grow(TM). An independent data safety monitoring board reviewed the medical data from the lowest dosing group and concluded that it was safe to proceed to the second dosing group. Six patients in the second dosing group have been enrolled and treated with Cardio Vascu-Grow(TM). To date, Cardio Vascu-Grow(TM) appears to be safe and well tolerated. Although primarily a safety study, CVBT will also collect efficacy data in the current trial to guide the next phase of clinical testing with Cardio Vascu-Grow(TM) in no-option heart patients.

Dr. Thomas Stegmann M.D., a professor, cardiovascular surgeon and Chief Clinical Officer for CVBT stated, "The results to date are consistent with the results I achieved in my two studies in 40 patients in Germany during 1995/96 and 1998/99 using the same protein. The results are promising and we will continue to investigate the use of Cardio Vascu-Grow(TM) for the treatment of Coronary Heart Disease." Dr. Stegmann led the first clinical study in which a human growth factor identical in structure to Cardio Vascu-Grow(TM) was injected into the hearts of no-option heart patients. These studies, published in peer-reviewed international Cardiology journals, were widely cited for their promising potential as a breakthrough treatment for coronary heart disease.

Mr. Daniel C. Montano, President of CVBT, said, "We recently announced that pre-clinical animal studies have shown positive results for our drug candidate Cardio Vascu-Grow(TM) in treating Peripheral Vascular Disease, minimizing the Stroke-Affected area in the brain, and accelerating the closing of Diabetic Wounds." Mr. Montano further remarked, "It is exciting to report that Cardio Vascu-Grow(TM) appears to be safe and well tolerated as a treatment for Coronary Heart Disease. Our goal is to replicate in the U.S. the very promising clinical results Dr. Stegmann observed in his German clinical studies. CardioVascular BioTherapeutics, Inc. is committed to conducting additional clinical trials to establish the positive affect of our drug candidate aimed at improving the quality of life for those suffering from heart disease, stroke, diabetic wounds, peripheral vascular disease and pledges to continue exploration for additional applications of Cardio Vascu-Grow(TM)."

Persons wishing further information on the FDA trials or copies of Dr. Stegmann's publications on his German clinical trials should request a copy at the website www.CVBT.com.

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) is a biopharmaceutical company focused on developing a new drug for the treatment of cardiovascular diseases where the growth of new blood vessels can improve the outcome for patients with these diseases. Its drug candidate, Cardio Vascu-Grow(TM), is designed to facilitate the growth of new blood vessels in the heart and other tissues with an impaired vascular system.

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 future revenues, cash usage and our cash flow breakeven point are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of Cardio Vascu-Grow(TM), market acceptance of CardioVascular BioTherapeutics, Inc. products by our customers, 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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