Angiogenesis: Berlex Coronary Angiogenesis Trial

Study of:
Ad5FGF-4 Drug

The Minneapolis Heart Institute Foundation participated in the largest gene therapy trial in the world ever done to promote growth of new blood vessels in the heart muscle (myocardial angiogenesis). There were 416 patients enrolled in this gene therapy trial from 65 different research centers across the United States. Gene therapy refers to the process in which DNA is introduced into cells. The DNA then directs those cells to produce a specific protein. This study delivered a fragment of DNA that produces a protein called FGF (growth factor). The DNA was introduced into the heart during a coronary angiogram. This DNA can influence the heart cells to produce FGF. FGF is a protein that helps grow small blood vessels in the heart which would increase blood flow to the heart muscle.

The FGF study (or “Berlex” study as some of our patients know it) objectives were to: (1) improve exercise time, (2) improve quality of life, and (3) decrease chest pain in patients who were not candidates for revascularization. Overall patients did not show improvement in exercise time. However, high risk patients did show improvement in exercise. These high risk patients had more severe and frequent episodes of angina (chest pain) and lower exercise ability. Overall, patients did have improvement in chest pain. We were the number one site in the United Statesand Dr. Henry presented the results at the annual AmericanCollegeof Cardiology meeting in March of this year. All of our 39 patients were considered high risk and overall patients enrolled at the Minneapolis Heart Institute Foundation had improvement in exercise time and angina. We would like to thank everyone who participated in this exciting and important trial.

We are encouraged by the results of the FGF trial but we think we can do better. In our new gene therapy study, the DNA for VEGF2 (vascular endothelial growth factor 2) is injected directly into the heart muscle during a coronary angiogram. This DNA directs the heart cells to produce VEGF2. VEGF2 is a protein that helps grow small blood vessels in the heart which would increase blood flow to the heart muscle.

The purpose of this study is to see if VEGF2 can help grow more blood vessels in your heart. VEGF2 is a growth protein specific to arteries. VEGF2 is naturally produced in the human body to start the growth of tiny arteries, called collateral vessels, in the areas where blood flow is limited. Limited blood flow to the heart, caused by narrowed or blocked arteries, may cause angina (chest pain). By giving you more of what your body produces, we hope to improve blood flow to the heart and decrease or eliminate angina.

This study is designed to evaluate how well VEGF2 works and to further test its safety. Patients will return for 8 follow-up visits during the first 12 months after the angiogram and may be asked to return for annual visits for up to 14 years.

Timothy D. Henry, MD, FACC

Randall K. Johnson, MD, FACC

Anil K. Poulose, MD, FACC

Jay H. Traverse, MD, FACC, FAHA

Karen L. Harvey, RN

Rachel Olson, RN, MS, CCRC

Dodie Walton, RN, CCRC

For more information about the OPTIMIST Program at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Terri Streufert at 612-863-7821.