Emory Crawford Long Hospital is one of 32 sites participating in a nationwide study of experimental gene transfer designed to stimulate new blood vessel growth in the heart.
Researchers hope this treatment will restore blood flow to ischemic areas of the heart in patients who suffer from severe angina (chest pain) due to coronary artery disease and who have few or no remaining treatment options.
The current trial is a randomized, double-blind, placebo controlled and dose escalating Phase IIb study, is known as GENASIS (Genetic Angiogenic Stimulation Investigational Study). Atlanta-based Corautus Genetics is sponsoring the study.
The procedure involves injecting a special gene directly into the heart muscle in six places through a specialized catheter. The goal is for the gene to provide the heart with "instructions" to grow new blood vessels, which help to bring more oxygen to oxygen-starved areas of the heart - and relief from the angina.
"We are very interested in this trial and its outcome," says Henry Liberman, MD, associate professor, cardiology, Emory University School of Medicine, principal investigator on the Emory Crawford Long Hospital study. "We are hopeful that the gene transfer therapy, called VEGF (Vascular Endothelial Growth Factor), will be beneficial to our patients with refractory angina. These patients have few or no other remaining options."
The results of the earlier Phase I and Phase IIa trials have been very encouraging, notes Dr. Liberman. "Naturally, we want to see this through to the next phase, in which larger numbers of patients are tested so we can provide the necessary proof that it really works. The evidence that we have so far is very promising and we're looking forward to taking those steps."
According to Corautus Genetics, Inc., earlier trials of this therapy in 55 patients who suffered from moderate to severe refractory angina (Class 3 or 4), showed that 70 percent reported a reduction in angina of two or more classes. Patients also experienced a significant reduction in episodes of angina from an average of 32 per week to seven per week. These effects were sustained for at least two years and there were no associated safety issues.
The American Heart Association reports that 150,000 to 250,000 Americans each year are diagnosed with refractory angina. Currently the average life span of these individuals is 5 years. There have been no gene therapies thus far approved for marketing by the FDA.
GENASIS, the largest trial of its kind, is sponsored by Corautus Genetics, Inc., the biopharmaceutical company that holds the rights to the type of gene transfer therapy being studied in the GENASIS.
Anyone interested in obtaining more information or enrolling in GENASIS should call Emory HealthConnection at 404-778-7777.