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news.CardioVascular BioTherapeutics has announced 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, the company anticipates announcing additional sites as they open for enrollment.
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In this Phase II trial, CardioVascular BioTherapeutics’s (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 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.
Daniel Montano, CVBT’s president and CEO, said: “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.
“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.”