September 12, 2005
Can transferred genes tell hearts to heal themselves?
BY Suzanne faulk
Crawford Long Hospital is one of 32 sites participating in a nationwide study of an 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—a randomized, double-blind, placebo-controlled and dose-escalating Phase IIb study—is known as GENASIS (Genetic Angiogenic Stimulation Investigational Study). The project is sponsored by Atlanta-based Corautus Genetics Inc., which holds the rights to the type of gene transfer therapy being studied.
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 angina.
“We are very interested in this trial and its outcome,” said Henry Liberman, associate professor of cardiology and principal investigator for the Crawford Long arm of the 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 remaining options.”
Earlier Phase I and Phase IIa trials have been encouraging, Liberman noted. “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,” he said. “The evidence we have so far is very promising, and we’re looking forward to taking those steps.”
According to Corautus Genetics, 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 angina episodes, 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 150,000–250,000 Americans each year are diagnosed with refractory angina. Currently the average life span of these individuals is five years. There have been no gene therapies thus far approved for marketing by the Food & Drug Administration.
Anyone interested in obtaining more information or enrolling in GENASIS should call the Emory HealthConnection at 404-778-7777.