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HOECHST-ROUSSEL VELNACRINE MALEATE PHASE III TRIAL IN ALZHEIMER’s

Executive Summary

HOECHST-ROUSSEL VELNACRINE MALEATE PHASE III TRIAL IN ALZHEIMER's disease is expected to begin shortly. Hoechst-Roussel said last July that the cholinergic enhancer (HP-029), which inhibits the breakdown of the neurotransmitter acetylcholine, was continuing in Phase II development for the memory loss symptoms of early stage Alzheimer's. At the time, 375 persons had enrolled in the trials and anecdotal evidence indicated a 30%-50% response rate. FDA has allowed patients who completed the trials to continue taking the drug. The company has conducted an interim analysis of 100 patients in the Phase II velnacrine maleate study and is "trying to expedite" the development of the drug, Hoechst-Roussel Pharmaceuticals President Victor Bauer, PhD, told "The Pink Sheet." The Phase III expanded patient trial will include the participants from the Phase II study. A chemically related compound, suronacrine maleate (HP-128) also is in clinicals for Alzheimer's. Hoechst-Roussel is completing Phase I studies with the second generation cholinesterase inhibitor and Phase II is "about to start," Bauer said. Because of the early stage of human studies, the company does not yet have efficacy results, but the drug appears to have an adrenergic effect as well as its cholinergic activity, he noted. * Hoechst-Roussel expects to file an IND for an acetylcholine agonist for Alzheimer's "within one or two months," Bauer said. He described the compound (designated HP-749) as an acetylcholine "agonist-type" drug that also has "adrenergic properties." The IND submission will mark the third Alzheimer's drug to enter U.S. clinicals from Hoechst-Roussel Pharmaceuticals. Hoechst AG also has several Alzheimer's treatments in development. In a videotape presented at the meeting, Director-Clinical Neuroscience Michael Murphy, MD/PhD, predicted that "in five years" the company will have "effective symptomatic" treatments "not cures" for Alzheimer's. The degenerative disease is estimated to affect approximately 4 mil. Americans and kill 100,000 per year in the U.S. * In the related area of vasotherapeutics, Hoechst-Roussel is actively developing two drugs that build on its Trental (pentoxifylline) development work -- propentofylline and torbafylline. Trental is in clinicals as a treatment for multi-infarct dementias. One study has been completed and two new trials are underway. Propentofylline (HWA-285), which can prevent nerve cell damage, is being studied for senile dementia. Hoechst says the cerebral metabolism activator is in Phase II/III. The drug is already marketed in Japan. Torbafylline (also known as HWA-448) is in Phase II development for peripheral vascular disease and myopathy. Hoechst-Roussel Pharmaceuticals' U.S. parent Hoechst-Celanese said March 6 that the Life Sciences Group, which includes the Hoechst-Roussel, Pharmaceutical Production, Animal Health and Crop Protection units, recorded 1989 sales of $500 mil., up 8.5% from 1988, with an operating income of $55 mil., a 17% increase.
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