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GENSIA COMPLETES PHASE 3 GENESA(TM) SYSTEM CLINICAL TRIAL

 SAN DIEGO, Calif., June 15 /PRNewswire/ -- Gensia Inc. (NASDAQ: GNSA), today announced that it has completed patient enrollment in multicenter Phase 3 clinical trials in the United States, Western Europe and Canada, with the GenESA system in the diagnosis of patients with coronary artery disease, in conjunction with electrocardiography (ECG), echocardiography and radionuclide imaging. Approximately 700 patients were enrolled in the U.S and international studies conducted at 63 centers.
 "We expect data consolidation, review, and analysis to be completed in the third quarter of 1993. Assuming a favorable outcome of these results, we plan to make regulatory submissions in the U.S., Western Europe and Canada in the fourth quarter of 1993," said David F. Hale, chairman, president and chief executive officer.
 Gensia was recently notified by the Committee for Proprietary Medicinal Products (CPMP) in Europe that the GenESA System would be reviewed under the "high tech" procedures as a Group "B" product. Group "B" products are pharmaceutical products representing significant innovation, such as the first of a new class of drugs, drugs which treat diseases in which no adequate therapy exists, or drugs prepared in unique dosage forms. The "high tech" procedure coordinates the review of these pharmaceutical products in countries which are members of the European Community (EC).
 The company expects that data from the U.S. Phase 3 clinical trial program for the GenESA system will be submitted for presentation at a major medical meeting in the first half of 1994.
 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 in conjunction with currently used methods of cardiac diagnostic testing including ECG, echocardiography and radionuclide imaging. A primary clinical need for the GenESA System is expected to be 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 because of 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 the diagnosis of coronary artery disease to be made. The GenESA System is also expected to enhance echocardiography and radionuclide imaging procedures which may be difficult to perform in conjunction with physical exercise.
 Gensia Clinical Partners owns certain rights to the GenESA System technology which are subject to a purchase option by Gensia.
 Gensia Inc. 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- 6/15/93
 /CONTACT: Elizabeth A. Gard of Gensia Inc., 619-546-8300/
 (GNSA)


CO: Gensia, Inc. ST: California IN: MTC SU:

EH -- SD005 -- 2189 06/15/93 13:49 EDT
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Publication:PR Newswire
Date:Jun 15, 1993
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