CVBT is focused on receiving approval from the Food and Drug Administration (FDA) to market FGF-1 in the United States, for the treatment of patients with severe coronary heart disease, by conducting FDA-authorized clinical trials in the U.S.  We 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. Two earlier clinical studies in Germany also demonstrated the activity of FGF-1 in stimulating angiogenesis, blood perfusion, and improved clinical symptoms, including chest pain and exercise tolerance. Read a summary of the pioneering clinical studies of FGF-1 conducted in Germany. Please check back for a summary of our U.S. FDA approved Phase I clinical trial.

In July 2007, we obtained authorization from the U.S. FDA to proceed with a Phase II clinical trial for our protein drug candidate, 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.

Phase II
CVBT-141H – Severe Coronary Heart Disease
 

Phase I
CVBT-141B - Wound Healing
CVBT-141C – Peripheral Arterial Disease

For the most current information on the status of these trials, including many details about the process, please visit www.clinicaltrials.gov.

Use of this site constitutes agreement to our Terms and Conditions
and Privacy Policy. Site Design and Contents © 2008 CardioVascular BioTherapeutics, Inc. All Rights Reserved.

Some content on this site requires the free Adobe Reader.