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Executive Summary

BEECHAM's EMINASE HAS BEEN STUDIED IN "AT LEAST 1,000" PATIENTS worldwide, the company's U.K. pharmaceutical research manager Harry Ferres, PhD, told a press symposium Sept. 15 tied to Eminase (APSAC) clinical presentations at the World Congress of Cardiology meeting in Washington, D.C. Although APSAC has not yet reached the market either in the U.S. or overseas, Beecham anticipates approvals "toward the middle of next year" in two European countries, Ferres said. The thrombolytic agent, now in Phase III studies in the U.S., is active in 25 research centers in the U.S., including a five-center study in 200 patients directed from Salt Lake City, Utah. The "major advantage" of APSAC treatment over other thrombolytic agents, including urokinase, streptokinase, and tissue plasminogen activator (TPA), Stewart Hillis, MD, a clinical investigator, noted, "is that it can be given slowly for five minutes" and, therefore, can be made "available to either community physicians . . . or paramedics." Hillis was one of three investigators at the symposium presenting APSAC clinical data at the cardiology congress. Ferres pointed out that APSAC is administered in a 30 mg bolus injection over five minutes time. APSAC's administration compares with infusion treatments of approximately an hour for urokinase and streptokinase, and possibly longer for TPA. Ferres said that with TPA "the infusion rate has commonly been something like three hours, with proposals and some of the latest clinical trials going up even beyond that time." APSAC also has a longer half-life than any of the other thrombolytic agents, Ferres said. "With a half-life of an hour and a half, that means you have fibrillating activity in the blood stream for several hours," Ferres observed. "That contrasts with TPA, for example, that has a half-life of five minutes and streptokinase and urokinase which have half-lives of 15 minutes." Ferres asserted that the longer half-life of Eminase makes it possible to avoid the long infusion rates and reduces the danger of reocclusion.

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