By Staff Reports
(DGIwire) – Angina is chest pain or discomfort caused when the heart muscle doesn’t get enough oxygen-rich blood, according to the American Heart Association (AHA). The discomfort can also occur in the shoulders, arms, neck, jaw or back. Here are three key things to know about this condition:
“In contrast to the time-honored methodologies for addressing angina, such as drug therapy and mechanical revascularization procedures including bypass surgery and stents, there is an emerging third category: medical revascularization,” says Christopher Reinhard, CEO of Angionetics. “This involves the use of gene therapy to boost the heart’s ability to grow new arteries.”
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—called cardiac microvascular gene therapy—the 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.
“Broadening the physician’s toolkit when it comes to the treatment of angina is a win-win for the medical community and all patients who are affected by this painful condition which limits a patient’s capacity for physical exertion,” Mr. Reinhard says.
To learn more about the upcoming AFFIRM study, visit www.myrefractoryangina.com or talk to your doctor.