Clinical Trial Results Promising for Patients with Moderate to Severe Angina

Tuesday, October 11, 2005

SCOTTSDALE, Ariz. — Heart patients with severe angina (chest pain) previously considered too ill to respond to treatment may benefit from cutting-edge gene transfer technology being studied by Mayo Clinic. The study investigates a procedure that may help the heart grow new blood vessels.

Mayo is one of more than 30 national sites participating in the clinical trial - the largest study of its kind - that could result in a new method to treat advanced coronary artery disease. Named GENASIS (Genetic Angiogenic Stimulation Investigational Study), the study targets patients with angina who have no further treatment options open to them. Their pain is so debilitating that often they are unable to perform routine physical activities.

The procedure involves using a specially designed catheter to deliver therapeutic DNA to the affected heart muscle. The DNA signals the heart to grow new blood vessels to bring needed blood flow and oxygen to the muscles. In phase one of the study, 30 percent of the patients experienced complete elimination of the angina symptoms and 70 percent experienced significant improvement in symptoms.

The clinical trial is intended to evaluate the safety and efficacy of injecting a growth factor, called Vascular Endothelial Growth Factor-2 (VEGF-2) directly into the heart. VEGF-2 is believed to promote the development of collateral blood vessels, called "helper" blood vessels, to provide better blood flow to affected areas of the heart that have inadequate blood flow because of blocked arteries.

"Thousands of patients are crippled with severe angina despite all the treatments such as angioplasty, bypass surgery and various medications developed in the past 20 or 30 years," notes F. David Fortuin, M.D., cardiologist at Mayo Clinic who leads the study. "Because of the encouraging findings in the first phase of the study, we look forward to the results of this new trial."

The GENASIS trial is still enrolling patients at Mayo Clinic in Arizona. Those who may be eligible - and/or their caretakers - may first call 1-877-9ANGINA (1-877-916-4462 to find out if they are eligible. Then, if eligibility is determined, those interested in participating in the trial may call Debbie Unger, RN, Mayo Clinic, at 480-342-5882.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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