(DGIwire) – The past several decades have witnessed a series of remarkable breakthroughs in the area of heart care. Here are six advances that have propelled the state of coronary medicine and given heart patients a new lease on life.
“The steady pace of innovation in heart care has truly opened new possibilities for treating patients in an effective manner,” says Christopher Reinhard, CEO of Angionetics. “We are focusing on innovations in microvascular gene therapy and have been encouraged by positive results from clinical studies conducted to date.”
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.
“Nobody can say where the path of discovery in heart science will lead us tomorrow—but we are justified in being excited by the cutting-edge of the field as it stands today,” Mr. Reinhard adds.
To learn more about the upcoming AFFIRM study, visit www.myrefractoryangina.com or talk to your doctor.