Gene Therapy Trials

BERLEX Trial

Name of Trial: BERLEX - A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Patients with Stable Angina

CPHS #: 15582

Start Date: November 2001

End Date: November 2006

Description of Trial: The purpose of the study is to learn about the use of gene therapy for patients with angina pectoris. The major questions include:

• Can Ad5FGF-4, an investigational drug, be administered safely?
• Will such therapy stimulate the growth of new blood vessels in the heart?
• Assuming this new growth occurs, will this benefit patients with angina pectoris?

It is hoped that development of new blood vessels will increase the amount of blood flow to the heart muscle, thereby decreasing the amount of chest pain experienced.

Gene therapy refers to a new form of therapy in which genes are introduced into cells. The gene is carried into your heart cells by a modified virus that is similar to one that can cause the common cold. It has been modified in the lab to prevent it from multiplying, thereby preventing it from causing infection. The gene has been attached to the modified virus in a way that makes it possible for the virus to carry it into your cells. Once inside the cell it can then go to work and stimulate the cell to make new blood vessels. In this study, the gene will be given to you during a cardiac catheterization procedure.

For more information on research at the Dartmouth-Hitchcock Medical Center, please visit either the DHMC Clinical Trials site or the Dartmouth Medical School Research page.