LAS VEGAS, Sept. 9 CardioVascularBioTherapeutics, Inc. (OTC Bulletin Board: CVBT) today announces that itsfirst US site is open for patient enrollment for its Phase II clinical trialfor the treatment of severe coronary heart disease. In the coming weeks, CVBTanticipates announcing additional sites as they open for enrollment. Forcurrent details about the clinical sites participating in CVBT's Phase IIheart trial, please visit http://www.cvbt.com.
In this Phase II trial, CVBT's drug candidate containing human FibroblastGrowth Factor-1 (FGF-1), will be injected into patients' hearts, stimulating ahealing process called angiogenesis. The drug will be delivered using theNOGA(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 monthhistory of chronic stable angina triggered by physical exertion and must havea Canadian Cardiovascular Society (CCS) anginal classification III or IV whilereceiving optimal medical therapy. Their treating cardiologist will havedetermined that they are generally not suitable for interventional therapy orbypass surgery.
"Developing a clinical trial protocol such as ours takes an extraordinaryamount of time and effort, and I am pleased to finally open our Phase II hearttrial for patient screening," said Daniel C. Montano, CVBT's President andCEO. "I expect additional investigators at other hospitals to begin screeningpatients in the coming weeks. Our target is 30 hospitals for thisinternational Phase II heart trial."
About CardioVascular BioTherapeutics
CVBT (OTC Bulletin Board: CVBT) is a biopharmaceutical company developinghuman FGF-1 for cardiovascular diseases characterized by inadequate blood flowto a tissue or organ. In addition to the Phase II trial it is conducting inpatients with severe coronary heart disease, the company has twoFDA-authorized clinical trials in the areas of impaired wound healing seen indiabetics and in patients suffering from peripheral artery disease of thelegs. An additional study is being conducted in patients with chronic backpain who may have perfusion defects to their spine. For more information aboutCardioVascular BioTherapeutics, Inc. please visit http://www.cvbt.com.For media inquiries please contact: Allison Caplan, (702) 839-7200 [email protected]
For investor inquiries please contact: Investor Relations, (702) 839-7220 [email protected]
SOURCE CardioVascular BioTherapeutics, Inc.