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SMITHKLINE BEECHAM’s OXIRACETAM BEGINNING PHASE II ALZHEIMER TRIAL

Executive Summary

SMITHKLINE BEECHAM's OXIRACETAM BEGINNING PHASE II ALZHEIMER TRIAL at the University of Texas Southwestern Medical Center in Dallas. SmithKline Beecham hopes to file an NDA for the nootropic agent by the end of 1992. The drug has previously been reported to be in Phase III trials. The company now reports that no Phase III oxiracetam studies are in progress. The product was launched in Italy as Neuromet in the second quarter of 1987 ("The Pink Sheet" Feb. 6, 1989, T&G-6). SmithKline Beecham markets the drug in Italy, where it holds all rights. In the rest of Europe, the company shares rights with Ciba-Geigy. Nova Pharmaceuticals, which was developing oxiracetam with SmithKline, no longer has a stake in the drug after the restructuring of the partnership between the two companies in April. The original Nova/SmithKline deal struck in May 1988 included joint development and marketing of CNS agents, including oxiracetam ("The Pink Sheet" April 30, T&G-10). The oxiracetam study based in Dallas is one of four multicenter Alzheimer's drug studies getting started at the UT Southwestern Medical Center under the auspices of the Southwestern Clinic for Alzheimer's and Related Diseases (SWCARD). The oxiracetam study is headed by neurologist Ronald Tintner, MD, The study, which will eventually treat up to 48 patients, is still enrolling subjects. Oxiracetam will be administered twice a day under the protocol. Southwestern Medical is also enrolling patients for a Phase II ACE inhibitor study for Alzheimer's patients, age 50 to 80, with "moderate memory loss and good general health." The study will investigate the correlation between improved blood flow and memory and cognition. The unnamed ACE inhibitor under study at Southwestern apparently is not Bristol-Myers Squibb's Capoten (captopril). That drug has recently completed clinicals at 10 centers for Alzheimer's Disease; results of those trials are being analyzed. In a recent newsletter, Southwestern further reports the initiation of a study of an oral version of Forest Labs' Synapton (physostigmine), which "seems to increase (the brain's) production of acetylcholine," in 30 healthy Alzheimer's patients age 50 or older. Synapton is being studied in 26 Phase III double-blind, placebo-controlled efficacy and formulation trials at medical centers in the U.S. and U.K. The drug was formerly called Cogmine. PruBache (PruTech III) is providing $6.7 mil. in financing in exchange for future royalities on the drug ("The Pink Sheet" July 30, T&G-14). The UT Southwestern Medical Center is also the site of a Phase I phenylindolinone study in 20 healthy Alzheimer's patients, 55 or older. The drug has been found to "enhance potassium-induced releases of acetylcholine." The phenylindoline study is scheduled to begin in October.

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