Cardiovascular BioTherapeutics, Inc. Doses First Patient in its Phase II Clinical Trial for Severe Coronary Heart Disease
Published: Nov 25, 2008
LAS VEGAS, Nov. 25 /PRNewswire-FirstCall/ -- 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.
To learn more about enrollment, patients or caregivers should contact clinical sites participating in the study directly. Active participating sites can be found by visiting http://www.cvbt.com.
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.
About Coronary Heart Disease
According to the American Heart Association's 2007 Update, among adults age 20 and older, an estimated 15.8 million Americans (2004) suffer from coronary heart disease (CHD). CHD is the single largest killer of Americans. According such Update, the estimated direct and indirect cost of CHD in the United States for 2007 is $151.6 billion.
About CardioVascular BioTherapeutics, Inc.
CVBT is a biopharmaceutical company developing human FGF-1 for cardiovascular diseases characterized by inadequate blood flow to a tissue or organ. In addition to the Phase II trial it is conducting in patients with severe coronary heart disease, the company is pursuing two FDA-authorized clinical programs in the areas of impaired wound healing seen in diabetes and in patients suffering from peripheral artery disease of the legs. Clinical research is being conducted in patients with chronic back pain who may have perfusion defects to their spine. For more information about CardioVascular BioTherapeutics, Inc. please visit http://www.cvbt.com.
This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding attaining maximum funding levels of clinical development agreements, the potential for drug candidates or therapies, the ability to raise capital in any form, the goals for CVBT, expectations for new research, progress with clinical trials or future business initiatives are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, future revenues, future expenses, future margins, cash usage and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.
CONTACT: Media, Allison Caplan, +1-702-839-7200, email@example.com, or
Investor, Amy Montano Gordon, +1-702-839-7220, firstname.lastname@example.org,
both of CardioVascular BioTherapeutics, Inc.
Web site: http://www.cvbt.com/