GENSIA ANNOUNCES COMPLETION OF ARASINE PHASE 3 TRIAL
GENSIA ANNOUNCES COMPLETION OF ARASINE PHASE 3 TRIAL SAN DIEGO, June 22 /PRNewswire/ -- Gensia Pharmaceuticals
(NASDAQ: GNSA) today announced that it has completed patient enrollment in a multicenter clinical trial in Western Europe and Canada with Arasine(TM) (acadesine) for use in patients undergoing coronary artery bypass surgery. A U.S. multicenter Phase 3 clinical trial with Arasine was completed in April of this year. Approximately 1,400 patients in total were enrolled in the U.S. and international multicenter studies, according to David F. Hale, chairman, president and chief executive officer.
"We expect data consolidation, review and analysis and preparation of the New Drug Application (NDA) for Arasine to take approximately six months to complete," said Hale. "We plan to submit the Arasine NDA to the Food and Drug Administration by the end of 1992 followed by the submission of a Marketing Authorization Application (MAA) to the European Economic Community under the procedure established by the European Committee for Proprietary Medicinal Products (CPMP). A Canadian regulatory filing for Arasine is planned for the first quarter of 1993." The primary objectives of the Phase 3 clinical trials with Arasine in patients undergoing coronary artery bypass surgery are to demonstrate that Arasine reduces the incidence of acute myocardial infarction (heart attacks) and the overall incidence of 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. The company expects that data from the U.S. Arasine Phase 3 clinical trial will be submitted for presentation at a major medical meeting in the first quarter of 1993 and that data from the international Phase 3 trial will be submitted for presentation at a medical meeting in mid-1993. According to Hale, "In addition to providing important clinical data on the efficacy of Arasine in patients undergoing coronary artery bypass surgery, the Phase 3 clinical trials should supply a large data base of information about adverse perioperative cardiovascular outcomes associated with coronary artery bypass surgery. We anticipate that several papers will be written by the clinical investigators who participated in these studies and that these papers would be submitted late this year for publication in medical journals in mid-1993." Gensia is also conducting a Phase 2 clinical with Arasine to investigate dosing regimens in patients undergoing non-cardiac surgery. The company expects to initiate a multicenter Phase 3 clinical trial with Arasine in the last half of 1992 in patients undergoing non-cardiac surgery who are at high risk of developing cardiovascular complications. 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- 6/22/92 /CONTACT: Martha L. Hough or Elizabeth A. Gard of Gensia Pharmaceuticals, 619-546-8300/ (GNSA) CO: Gensia Pharmaceuticals Inc. ST: California IN: MTC SU: KJ-JL -- SD001 -- 2250 06/22/92 09:05 EDT
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|Date:||Jun 22, 1992|
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