(DGIwire) – Heart disease now accounts for one in seven deaths in the U.S., according to the American Heart Association. For patients with a blood clot or a thick buildup of fatty material inside their artery walls, the blockage can rob nearby cells of oxygen and nutrients. Unless blood flow quickly resumes, the patient can suffer a heart attack or die. In less acute cases, reduced blood flow can trigger heart pain (“angina”) during exercise or exertion.
Although doctors can use stents or perform a bypass to address the damage, the heart has evolved its own natural mechanism for doing so: it can develop new channels, called collateral vessels, that redirect blood flow to oxygen-starved areas, according to Scientific American. These vessels, present from birth, don’t usually carry blood but can grow larger and form anew after severe blockage. But as Scientific American reports, only 20 to 30 percent of cardiac patients have a well-developed collateral circulation.
“Cutting-edge research is focusing on using gene therapy to boost the heart’s ability to grow new small collateral blood vessels in the majority of heart disease patients,” says Christopher Reinhard, CEO of Angionetics. “Significant strides are being made in testing to promote new blood vessel growth, which could help many patients avoid chest pain or prevent heart attacks. In contrast to existing drug therapy or mechanical revascularization, this new approach is called cardiac microvascular gene therapy.”
Angionetics’ product candidate, called Generx, involves the use of a specific gene that codes for a growth factor known as FGF-4. Studies have suggested this growth factor can play an instrumental role in the enlargement of existing or growth of new collateral vessels in the heart. The gene is first encased within a molecular delivery system known as an adenovector. The resulting molecular package—named Generx [Ad5FGF-4]—is then sent into the body as a one-time treatment during a standard angiographic procedure.
During this procedure, the gene therapy is administered into either the left or right coronary artery through a catheter that has been threaded up from the leg. The biologic is injected in front of a balloon that briefly blocks blood flow, allowing the treatment to more easily leave the blood vessel and enter the cardiac muscle. A one-time administration of the Generx product candidate promotes the development of new collateral vessels in the oxygen-starved sections of the heart, and the enlargement of existing collateral channels into medium-sized arteries.
Following a series of positive earlier-stage studies involving this therapy, the U.S. Food and Drug Administration recently cleared the Generx product candidate for late-stage Phase 3 clinical study (called the AFFIRM study) in the United States as a new, single dose treatment for patients with myocardial ischemia and refractory angina due to advanced coronary artery disease, to increase exercise capacity and reduce the frequency of angina episodes.
“One of the goals of our cardiac microvascular gene therapy is to potentially reduce the challenges that many heart disease patients would otherwise have to face,” Mr. Reinhard adds.
To learn more about the upcoming AFFIRM study, visit www.myrefractoryangina.com or talk to your doctor.