CardioVascular BioTherapeutics doses first patient in trial for severe coronary heart disease

Nov 25 2008

CardioVascular BioTherapeutics, Inc. , announced today that it has dosed the first patient in North America (NA) as part of its ACORD Phase II clinical trial to treat patients with severe coronary heart disease.

The ACORD (Angiogenesis for the treatment of CORonary heart Disease) trial will include four randomized, double-blind, placebo-controlled doses in approximately 120 patients with severe coronary heart disease. Thirty sites are expected to participate.

CVBT's 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(R) XP Cardiac Navigation system and the MyoStar injection catheter.

According to Daniel C. Montano, CVBT's CEO, "although it has taken longer than expected to reach this milestone, I am delighted that our Phase II heart trial is finally underway." Mr. Montano continued, "dosing the first patients is a major advancement in the development and verification of our drug."

Patients must be between 25 and 75 years of age with at least a three month history of chronic chest pain or discomfort triggered by physical exertion and must have severe coronary heart disease (a Canadian Cardiovascular Society (CCS) anginal classification III or IV). Patients must be receiving optimal medical therapy. Their treating cardiologist will have determined that they are generally not suitable for standard interventional therapy or bypass surgery.

About CVBT-141H

CVBT-141H contains and active ingredient -- human Fibroblast Growth Factor-1 (FGF-1). FGF-1 is a natural human protein that stimulates angiogenesis in the affected tissue or organ. Angiogenesis refers to the growth of new blood vessels that may help those suffering from coronary heart disease by increasing blood flow to ischemic tissue or tissue that has been damaged from lack of oxygen and nutrients from blood supply. By providing blood flow to the damaged regions of the heart, the tissues can regenerate.