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Cardiovascular BioTherapeutics, Inc. (CVBT.OB) Announces First Site to Begin Patient Enrollment for Its Phase II Heart Trial


9/9/2008 9:04:18 AM

LAS VEGAS, Sept. 9 /PRNewswire-FirstCall/ -- CardioVascular BioTherapeutics, Inc. today announces that its first US site is open for patient enrollment for its Phase II clinical trial for the treatment of severe coronary heart disease. In the coming weeks, CVBT anticipates announcing additional sites as they open for enrollment. For current details about the clinical sites participating in CVBT's Phase II heart trial, please visit http://www.cvbt.com.

In this Phase II trial, CVBT's drug candidate containing human Fibroblast Growth Factor-1 (FGF-1), will be injected into patients' hearts, stimulating a healing process called angiogenesis. The drug will be delivered using the NOGA(R) XP Cardiac Navigation system and the MyoStar(TM) injection catheter.

Subjects must be between 25 and 75 years of age with at least a 3 month history of chronic stable angina triggered by physical exertion and must have a Canadian Cardiovascular Society (CCS) anginal classification III or IV while receiving optimal medical therapy. Their treating cardiologist will have determined that they are generally not suitable for interventional therapy or bypass surgery.

"Developing a clinical trial protocol such as ours takes an extraordinary amount of time and effort, and I am pleased to finally open our Phase II heart trial for patient screening," said Daniel C. Montano, CVBT's President and CEO. "I expect additional investigators at other hospitals to begin screening patients in the coming weeks. Our target is 30 hospitals for this international Phase II heart trial."

About CardioVascular BioTherapeutics

CVBT is a biopharmaceutical company developing human FGF-1 for cardiovascular diseases characterized by inadequate blood flow to a tissue or organ. In addition to the Phase II trial it is conducting in patients with severe coronary heart disease, the company has two FDA-authorized clinical trials in the areas of impaired wound healing seen in diabetics and in patients suffering from peripheral artery disease of the legs. An additional study is being conducted in patients with chronic back pain who may have perfusion defects to their spine. For more information about CardioVascular BioTherapeutics, Inc. please visit http://www.cvbt.com.

CONTACT: Media Inquiries, Allison Caplan, +1-702-839-7200,
acaplan@cvbt.com, or Investor Relations, investorrelations@cvbt.com,
+1-702-839-7220, both of CardioVascular BioTherapeutics, Inc.

Web site: http://www.cvbt.com/



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