The product being evaluated as part of the multicenter, phase III AWARE clinical trial (Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization) is designed to promote angiogenesis - a natural process of blood vessel growth within the heart muscle. The injection is believed to work by stimulating a natural process of blood vessel growth within the heart muscle (angiogenesis), relieving insufficient blood flow within the heart muscle and the associated chest pain.
Insufficient blood flow (myocardial ischemia) is a common cause of chest pain in women with coronary artery disease (CAD). CAD is caused by the accumulation of fatty deposits within the walls of the arteries that can restrict the flow of blood to the heart muscle. It is also the most common cause of death in the United States, according to the American Heart Association.
"Chest pain is a common symptom of coronary artery disease, and women are more likely than men to experience related symptoms, such as unusual fatigue, sleep disturbances, gastrointestinal symptoms and shortness of breath," says Tsunehiro Yasuda, MD, a cardiologist at the Mass General Hospital Heart Center and primary investigator of the AWARE trial.
Current treatment strategies for CAD include beta blockers and other medications. Mechanical revascularization procedures such as stents, bypass and angioplasty can also treat angina for those who qualify. Despite these efforts, many patients continue to suffer from chest pains that impact their health and quality of life. In fact, it is estimated that between 300,000 and 900,000 patients in the United States continue to suffer from angina despite these therapies.
The AWARE trial is evaluating the efficacy and safety of an experimental injection of a fibroblast growth factor into the heart muscle. The gene therapy is administrated by guiding a catheter through the large blood vessel of the leg to the heart. Participants in the trial will have regular follow-up examinations over five years to determine the safety of the product and its effectiveness in promoting new blood vessel growth.
"The hope is that this injection will result in the growth of new blood vessels in the heart, which may mean better blood flow and less heart pain," says Yasuda. "A new treatment option would be a remarkable breakthrough for the 4.6 million women who suffer from angina."
Since 1984, more women than men have died each year from heart disease, and more than seven million women are currently living with CAD, the most common cause of death among women.