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GENSIA INITIATES PHASE 3 CLINICAL TRIALS WITH THE GENESA(TM) SYSTEM

GENSIA INITIATES PHASE 3 CLINICAL TRIALS WITH THE GENESA(TM) SYSTEM
 SAN DIEGO, April 8 /PRNewswire/ -- Gensia Pharmaceuticals Inc. (NASDAQ: GNSA) today announced that it is initiating Phase 3 clinical trials with the GenESA System (previously called the ESA System) in the diagnosis of patients with coronary artery disease. The GenESA System Phase 3 clinical trials program is scheduled to expand to approximately 60 major medical centers in the United States, Canada and Western Europe, according to David F. Hale, chairman, president and chief executive officer.
 "Gensia has tested arbutamine and the GenESA System in multi-center Phase 2 clinical trials in approximately 160 patients with coronary artery disease in the United States and certain European countries," said Hale. "Based on an interim analysis of the data from these clinical trials, arbutamine and the GenESA System appear to produce results equivalent to exercise stress testing when used with electrocardiography (ECG) and echocardiography (ultrasound imaging of the heart) to diagnose the presence of coronary artery disease. In our Phase 3 clinical trials program, we plan to test the GenESA System as an adjunct to ECG and echocardiography as well as radionuclide imaging in the diagnosis of coronary artery disease."
 The GenESA System combines a drug, arbutamine and a computer controlled drug delivery system designed to pharmacologically stress the heart to aid in the diagnosis of coronary artery disease. It is designed for use with currently used methods of cardiac diagnostic testing including ECG, echocardiography and radionuclide imaging. A primary clinical need for the GenESA System is for use with patients who are unable to undergo exercise stress tests or who have had inconclusive exercise stress ECG tests.
 The company estimates that in the United States, as many as 1.5 million patients who are candidates for testing for coronary artery disease are unable to exercise adequately due to physical disabilities or limitations. In addition, of the 6 million exercise stress ECGs performed each year in the United States, an estimated 20 percent to 30 percent of tests are inconclusive, frequently because the patient is unable to achieve a sufficient increase in heart rate for diagnosis of coronary artery disease to be made.
 The GenESA System is also expected to enhance echocardiography and radionuclide imaging procedures which are difficult to perform in conjunction with physical exercise. There are approximately 6 million echocardiography and 1.5 million radionuclide imaging procedures performed each year in the United States.
 Gensia Clinical Partners owns certain rights to the GenESA System technology which are subject to a purchase option by Gensia.
 Gensia Pharmaceuticals is a San Diego-based biopharmaceutical company formed to discover, develop, manufacture and market novel pharmaceutical products for the treatment and diagnosis of human diseases.
 -0- 4/8/92
 /CONTACT: David F. Hale, chairman, president and CEO, or Martha L. Hough of Gensia Pharmaceuticals, 619-546-8300/
 (GNSA) CO: Gensia Pharmaceuticals Inc. ST: California IN: MTC SU:


DM-CH -- LA007 -- 6318 04/08/92 13:57 EDT
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Publication:PR Newswire
Date:Apr 8, 1992
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