Patient Enrollment Begins for CVBT’s Phase II Heart Trial
September 10, 2008 - CardioVascular BioTherapeutics Inc. announced yesterday that the first U.S. site is open for patient enrollment in the company’s Phase II clinical trial for the treatment of severe coronary heart disease.
CVBT anticipates announcing the opening of additional sites for enrollment in the coming weeks.
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 XP Cardiac Navigation system and the MyoStar injection catheter.
Subjects must be between 25 and 75 years of age with at least a three-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."
For current details about the clinical sites participating in CVBT's Phase II heart trial, please visit http://www.cvbt.com/.
For more information: www.cvbt.com