Gensia Inc. announced Tuesday that it has completed patientenrollment in the multicenter Phase III clinical trial of itsGenESA system to diagnose patients with coronary arterydisease.
Approximately 700 patients were enrolled in the trials, whichwere conducted at 63 medical centers in the U.S., Europe andCanada. The trials were designed to test the GenESA system,which consists of the drug arbutamine and a computer-controlled drug delivery system designed to pharmacologicallystress the heart, as an adjunct to electrocardiography,echocardiography and radionuclide imaging.
Gensia of San Diego presented data from Phase II trials onarbutamine in March at the American College of Cardiologymeeting in Anaheim, Calif. Those data showed that arbutaminewas as effective as exercise (in stress tests) in provokingclinical, electrocardiogram and electrocardiographic evidence ofcardiac ischemia.
Gensia (NASDAQ:GNSA) initiated the Phase III trials on GenESAin April 1992. Now that the last patient is enrolled, thecompany "expects data consolidation, review and analysis to becompleted in the third quarter of 1993," according to DavidHale, the company's president and chief executive officer.
"Assuming a favorable outcome of these results," he continued,"we plan to make regulatory submissions in the U.S., WesternEurope and Canada in the fourth quarter of 1993." As well,Gensia intends to submit the U.S. trial data for presentation at a"major medical meeting" in the first half of 1994.
-- Jennifer Van Brunt Senior Editor
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