The Acord trial will include four randomized, double-blind, placebo-controlled doses in approximately 120 patients with severe coronary heart disease. Approximately 30 sites are expected to participate.
CardioVascular BioTherapeutics’s (CVBT) 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 XP cardiac navigation system and the MyoStar injection catheter.
Daniel Montano, CEO of CVBT, said: “Although it has taken longer than expected to reach this milestone, I am delighted that our Phase II heart trial is finally underway. Dosing the first patients is a major advancement in the development and verification of our drug.”