LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) announced today that the U.S. Food and Drug Administration (FDA) has authorized the company’s Phase II Clinical Protocol for its protein drug candidate, human fibroblast growth factor-1 (FGF-1), for the treatment of severe coronary heart disease.
The Phase II Clinical Protocol incorporates injection catheter delivery of FGF-1. The company plans to commence the international study at 30 medical centers in the U.S., Canada and Europe. It will work with Biologics Delivery Systems Group, Cordis Corporation, a worldwide leader in developing and manufacturing innovative technologies for interventional cardiologists, to identify clinical sites with expertise in utilizing the advanced NOGA® XP Cardiac Mapping System and the MyoStar™ Injection Catheter. The use of a catheter to deliver CVBT’s drug candidate permits the examination of a placebo control group in this Phase II trial, which was not possible when the drug was surgically administered in the Phase I study.
Thomas Stegmann, M.D., CVBT’s president and chief medical officer commented, “CardioVascular BioTherapeutics is extremely pleased that the FDA has favorably reviewed our proposed Phase II study, and that we will have access to the innovative cardiac navigational technology pioneered by the Johnson & Johnson family of companies. The NOGA XP Cardiac Navigation System will allow us to identify areas of damage in the heart, enabling us to accurately inject our protein therapy exactly where it is needed. Drug injections will be made with the investigational MyoStar Injection Catheter, distributed outside the U.S. by Biologics Delivery Systems. The combined use of the NOGA and MyoStar systems will give us confidence that our FGF-1 therapy will be reliably and safely administered to our patients.”
CardioVascular BioTherapeutics recently completed a Phase I clinical trial carried out at six medical centers in the U.S., which verified the safety and provided evidence of the biological activity of FGF-1 administration to the heart. No significant, unexpected adverse events were apparent in any of the patients treated, and preliminary indications of bioactivity were noted, even though the Phase I trial was not powered to demonstrate efficacy. Two earlier clinical studies in Germany in no-option heart patients also demonstrated the activity of FGF-1 in stimulating angiogenesis, blood perfusion, and improved clinical symptoms, including chest pain and exercise tolerance.
Conference Call and Webcast Information
Management will host a conference call for investors and other interested parties on Thursday, July 19, 2007 at 11:00 a.m. EST/8:00 a.m. PST to discuss this announcement and to answer questions. Individuals interested in listening to the conference call may do so by dialing (888) 927-9756 for domestic callers or (706) 679-0879 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (800) 642-1687 for domestic callers, or (706) 645-9291 for international callers, and entering reservation code 6349682.
The live conference call will also be available via the Internet on the Investor Relations section of the company’s Web site at www.cvbt.com. A slide presentation that accompanies management’s remarks will also be available on the Investor section of the site. A recording of the call will be available on the company’s Web site for 30 days following the completion of the call.
About CardioVascular BioTherapeutics
CVBT is a biopharmaceutical company developing drug candidates with human FGF-1 as their active pharmaceutical ingredient (API) for diseases characterized by inadequate blood flow to a tissue or organ. The company has three clinical trials underway with drug candidates to treat the following medical indications: severe Coronary Heart Disease (CVBT-141A), dermal wound healing in diabetics (CVBT-141B), and Peripheral Arterial Disease (CVBT-141C).
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 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.