Gene Therapy Trial for Severe Cardiovascular Disease Enrolling Patients at Mayo Clinic in Scottsdale

Wednesday, October 06, 2004

For Immediate Release – October 6, 2004

SCOTTSDALE, Ariz. – Mayo Clinic is the first medical center in Arizona, and one of only a handful of centers nationwide, to perform a gene transfer procedure as part of a clinical trial for the treatment of severe cardiovascular disease. The trial is intended to evaluate the safety and efficacy of injecting Vascular Endothelial Growth Factor-2 (VEGF-2), a growth factor believed to promote the development of supplemental collateral blood vessels, directly into the heart.

Called GENASIS, for "Genetic Angiogenic Stimulation Investigational Study," it is a randomized, double-blinded, dose-ranging and placebo-controlled study that will enroll patients with Class III or IV angina in approximately 20 cardiac medical centers in the United States. Class III and IV angina are the most severe forms of angina, with Class III characterized by a marked limitation of ordinary physical activity and Class IV described as an inability to carry on any physical activity without discomfort.

"We are pleased to be one of the first centers in the U.S. to begin the GENASIS trial to help patients with refractory myocardial ischemia, a debilitating condition which currently has no available treatment," comments F. David Fortuin, M.D., cardiologist at Mayo Clinic in Scottsdale. "Previous clinical trials with VEGF-2 for severe cardiovascular disease produced very encouraging findings, and we look forward to the results of this new trial."

About the Technology

VEGF-2 is a growth factor that is believed to promote the development of supplemental collateral blood vessels (so called "helper" blood vessels) providing improved perfusion to areas of the heart that have inadequate blood flow because of blocked arteries from coronary artery disease. In the procedure, VEGF- 2 DNA is delivered to the ischemic tissue in the heart muscle (i.e. tissue that has compromised blood flow and oxygen) using a special delivery catheter. Once administered, the DNA is taken up by cells, where the actual VEGF-2 protein is then produced (expressed). The VEGF-2 protein then stimulates the growth of new blood vessels by promoting the migration and proliferation of the specialized cells that are important in blood vessel formation.

About Coronary Artery Disease and Angina

Coronary artery disease is a condition characterized by a narrowing of the coronary arteries that reduces blood flow, and therefore oxygen, to the heart. The lack of blood flow and oxygen to an organ is referred to as ischemia, and myocardial ischemia refers to the lack of blood flow and oxygen to the heart muscle. The American Heart Association estimates that more than 13 million Americans have coronary artery disease.

Angina results from coronary artery disease and manifests as chest pain due to a lack of adequate blood supply to the heart muscle. Class III and IV angina are the most severe forms of this condition, affecting more than one-third of the 400,000 newly diagnosed cases in the United States each year. Approximately 6.8 million coronary patients in the United States have angina. Of these patients with angina, approximately 150,000 to 250,000 patients with Class III and IV angina annually are considered refractory, meaning they cannot be successfully treated with conventional cardiovascular therapies. In most cases, these patients have undergone multiple invasive procedures and/or surgeries that have been unsuccessful.

Cardiovascular disease is the leading cause of death representing approximately 38.5% of all deaths in 2001, according to the American Heart Association. Further, cardiovascular disease claims more lives each year than the next five leading causes of death combined.

For more information, or to see if you are a candidate for the GENASIS clinical trial at Mayo Clinic in Scottsdale, call 480-301-4626.

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 in Scottsdale 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 202-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.

###

To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. MayoClinic.com is available as a resource for your health stories.