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Rush Physicians Using Gene Therapy For Heart Patients With Moderate To Severe Chest Pains Who Do Not Benefit From Other Treatments

the patient's chest wall or arm to "bypass" the blocked blood vessels.

While both of these treatments have been shown to be successful in relieving severe chest pains resulting from blocked arteries, a significant percentage of patients eventually do not respond well to either treatment, often requiring another angioplasty or bypass operation, noted Schaer. "If gene therapy proves to be safe and effective, it will represent an important new approach to improve the quality of life in these seriously ill patients with refractory chest pain," said Dr. R. Jeffrey Snell, study co-investigator and Schaer's colleague at Rush.

In the new study, patients will be randomly assigned to receive the gene administered through a cardiac catheter threaded into the heart from a leg artery or a placebo delivered using the same method. As required by the U.S. Food and Drug Administration, the study is "double blinded," which means that neither the doctor nor the patient will know whether he or she is receiving the gene therapy or a placebo. For every three patients that receive the active gene, one will receive a placebo. Following treatment, patients enrolled in the study will be examined for chest pain at one month, three months and six months. A total of 404 patients will be enrolled in the study at the 20 study sites across the country.

The Genetic Angiogenic Stimulation Investigational Study (GENASIS) is funded by Corautus Genetics.

More than 11 million people in the United States suffer from coronary artery disease. Many patients receive medications to increase blood flow but nearly 500,000 angioplasties and coronary bypass procedures are performed each year in those patients who do not benefit from medication.


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Source:Rush University Medical Center


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