Heart Hospital investigates gene therapy to relieve chest pain in women with AWARE clinical research study

A clinical trial aimed at women with recurring heart disease is being tested at Banner Heart Hospital as part of a fast-track to Food and Drug Administration approval.

The AWARE clinical research study is a women-only study that is designed to evaluate the safety and effectiveness of an investigational medication called Generx™ for patients with angina.

Generx is an investigational medication that is designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, to improve blood flow. Generx is administered as a one-time intracoronary infusion during a coronary angiography procedure, using a standard diagnostic cardiac catheter. The medication is being developed by Cardium Therapeutics.

Banner Heart Hospital hosted its first candidate in July, a woman from Tombstone, Ariz. Banner Heart Hospital and Southwest Heart in Tucson are the only sites in Arizona administering the study. There are 49 other test sites for the AWARE study in the United States.

“Banner Heart Hospital is a very busy heart center and referral center,” said Robert Engler, MD, medical director for Cardium Therapeutics. Engler administered the medication and also spoke to Banner Heart Hospital staff about the study during his visit.

Engler said the study has been placed on a fast track to approval by the FDA because it “serves an unmet medical need.”

“There are six million people in the United States with recurrent angina despite medical treatment,” Engler said. “We really do need another way to relieve the symptoms.”

The testing sites are currently recruiting women with recurrent symptoms of angina despite medication or angioplasty/bypass surgery. The phase 3 AWARE study represents one of very few women-only cardiovascular clinical studies ever undertaken and reflects a growing awareness that heart disease in women is underserved even though it is a major health issue.

Being a woman is a leading risk factor for the return of angina within the first year following an interventional procedure. Women with documented coronary heart disease frequently have different symptoms than men. Instead of typical sub-sternal chest pain, women are more likely to experience unusual fatigue, sleep disturbances, gastrointestinal symptoms or shortness of breath.

About 300 people will take part in this study at about 50 sites. Six people will take part in the study at Banner Heart Hospital.

For additional information about the AWARE clinical study and enrollment information please visit www.clinicaltrials.gov/ct/show/ NCT00438867, call Tony Andrasfay at 858-436-1014 or contact the clinical site in your area. Please refer to this study by its ClinicalTrials.gov identifier NCT00438867.