CVBT Doses First Patient in its Phase II Clinical Trial for Severe Coronary Hea... ( LAS VEGAS Nov. 25 /- CardioVascularBi...)

CVBT Doses First Patient in its Phase II Clinical Trial for Severe Coronary Heart Disease

Date:11/25/2008

LAS VEGAS, Nov. 25 /PRNewswire-FirstCall/ -- CardioVascular BioTherapeutics, Inc. (OTC Bulletin Board: CVBT), announced today that it has dosed the first patient in North America (NA) as part of its ACORD Phase II clinical trial to treat patients with severe coronary heart disease. The ACORD (Angiogenesis for the treatment of CORonary heart Disease) trial will include four randomized, double-blind, placebo-controlled doses in approximately 120 patients with severe coronary heart disease. Thirty sites are expected to participate.

CVBT's drug candidate (CVBT-141H) contains a human protein, Fibroblast Growth Factor-1 (FGF-1), that will be injected into patients' hearts with the intent to stimulate a healing process called angiogenesis. The drug will be targeted and delivered using the 3-D mapping NOGA(R) XP Cardiac Navigation system and the MyoStar injection catheter.

According to Daniel C. Montano, CVBT's CEO, "although it has taken longer than expected to reach this milestone, I am delighted that our Phase II heart trial is finally underway." Mr. Montano continued, "dosing the first patients is a major advancement in the development and verification of our drug."

Patients must be between 25 and 75 years of age with at least a three month history of chronic chest pain or discomfort triggered by physical exertion and must have severe coronary heart disease (a Canadian Cardiovascular Society (CCS) anginal classification III or IV). Patients must be receiving optimal medical therapy. Their treating cardiologist will have determined that they are generally not suitable for standard interventional therapy or bypass surgery.

To learn more about enrollment, patients or caregivers should contact clinical sites participating in the study directly. Active participating sites can be found by visiting http://www.cvbt.com.

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