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GENSIA ANNOUNCES COMPLETION OF ARASINE U.S. PHASE 3 TRIAL, INTERNATIONAL PHASE 3 TRIAL TO CONTINUE

 GENSIA ANNOUNCES COMPLETION OF ARASINE U.S. PHASE 3 TRIAL,
 INTERNATIONAL PHASE 3 TRIAL TO CONTINUE
 SAN DIEGO, April 14 /PRNewswire/ -- Gensia Pharmaceuticals Inc. (NASDAQ: GNSA) today announced that it is completing patient enrollment in a multi-center U.S. Phase 3 clinical trial with Arasine(TM) (acadesine) for use in patients undergoing coronary artery bypass surgery. The company also announced that it has enrolled approximately 630 patients in its international Phase 3 clinical trial with Arasine, and has decided to continue to enroll an additional 170 patients to complete the study with approximately 800 patients, according to David F. Hale, chairman, president and chief executive officer.
 In accordance with the Phase 3 study protocol, an outside safety and data monitoring panel conducted an interim analysis of data from approximately one-half the patients in the U.S. Phase 3 clinical trial. Based on information from the outside safety and data monitoring panel, Gensia is completing enrollment in the U.S. Phase 3 clinical trial with approximately 600 patients, as planned, and will extend enrollment in the international Phase 3 clinical trial to increase the probability that a significant result is achieved. Gensia personnel and the Phase 3 clinical investigators remain blinded to the results of both of the Phase 3 clinical trials.
 According to Hale, "We plan to complete the additional patient enrollments in the international study by mid-year and plan to file a computer assisted New Drug Application (CANDA) with the FDA in the U.S. and a MAA in Western Europe. Both of these filings are expected by year-end 1992, followed by a regulatory filing in Canada in early 1993."
 The primary objective of the Phase 3 clinical trials with Arasine in patients undergoing coronary artery bypass surgery is to demonstrate that Arasine reduces the incidence of acute myocardial infarction and other adverse cardiovascular outcomes associated with the surgery. The secondary objectives of the Phase 3 clinical trials are to investigate whether Arasine can improve cardiac function, reduce the overall incidence, severity and duration of ischemia, and improve patient recovery after surgery, thus potentially providing significant clinical benefits and cost savings.
 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- 4/14/92
 /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-JL -- SD002 -- 8206 04/14/92 11:05 EDT
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Publication:PR Newswire
Date:Apr 14, 1992
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