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Executive Summary

BOOTS FLOSEQUINAN (MANOPLAX) U.S. DOSE STUDIES SHOULD BE COMPLETED this summer and congestive heart failure mortality trials could begin early next year, University of Michigan Director of Cardiology Bertram Pitt predicted to a recent conference on new drug developments. "There are several large studies going on in this country as well as in Europe," Pitt reported. The current work is focused on "very careful dose/response studies." The University of Michigan researcher noted that "[Milton] Packer [Mount Sinai Medical Center] is running one [study]; I am running one. There are several going on in England right now." Mortality trials, Pitt said, "are planned for early 1990 or later this year." The first trials, he noted, will probably begin in England and will compare flosequinan to a converting enzyme inhibitor in a head-to-head comparison trial to look at mortality." Pitt said that he may become involved in a large U.S. trial with Packer to look "at the role of flosequinan on the base of converting enzyme inhibitor." The follow-up U.S. study "will take patients who already have received a converting enzyme inhibitor and then randomize placebo on top of that so combining vasodilators." The Boots drug is "an agent which I think has great promise is in heart failure," Pitt declared. He described the product as "a mixed arterial and venal dilator." In shorthand, he termed the product an "oral nitroprusside, which has both arterial and venal dilating effects." The exact mechanism of action is unknown, Pitt acknowledged but he speculated that "it probably affects calcium flux within the vascular wall. Very little tolerance has been demonstrated; very high compliance, very low side effect rate." Pitt made his comments on the Boots research compound at a May 4 conference on the NDA Pipeline sponsored by "The Pink Sheet" and International Business Communications.

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