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DUPONT MERCK's ALZHEIMER's DRUG LINOPIRINE ENTERING PHASE III

Executive Summary

DUPONT MERCK's ALZHEIMER's DRUG LINOPIRINE ENTERING PHASE III trials in 750 patients at 55 centers in the U.S. and Canada, the DuPont Merck Pharmaceutical joint venture announced July 11. Linopirine (DUP 996) is a second generation Alzheimer's drug, a cognition enhancer that DuPont Merck says improves the release not only of acetylcholine in the brain, but also of dopamine and serotonin. The Phase III trial will look for improvements in progressive Alzheimer's symptoms such as "memory loss, lack of attention and disabilities in activities of daily living," DuPont Merck said. Patients in the Phase III trials will participate in a double- blind, placebo-controlled protocol with no enhancement or crossover from placebo to drug. In the U.S., patients will receive either 30 mg or 40 mg of linopirine three times a day or placebo. Canadian trial participants will receive either 30 mg linopirine t.i.d. or placebo. Patients who are eligible to enter the trials must be age 52 or older with a confirmed diagnosis of Alzheimer's and with mild- to-moderate progressive dementia for at least six months, DuPont Merck said. The protocol allows enrollment of patients taking other medications for "some other disease, such as mild hypertension and controlled diabetes, as long as these medications do not affect" the central nervous system, DuPont Merck noted. DuPont Merck is not discussing the specific endpoints that will be used in the trial to assess efficacy. However, the company said that patients will be evaluated for both memory function and cognitive function under clinical assessments that are "in line" with FDA's proposed anti-dementia trial guidelines. The entry criteria also require that each patient have a dedicated caregiver who will ensure that the trial participant takes linopirine each day as directed and who will accompany the patient on doctors' office visits. The first patients in the clinical trial are expected to begin receiving linopirine this month, the company said. Patients in the study will be in the active phase of the study for three months and will continue on the drug during an automatic three-month extension. Further extensions of the active phase are possible, the company added. The patients will be required to visit a physician's office once a month for the six-month period. The 55 centers participating in the linopirine study are spread across two dozen states and 19 research sites in Canada. DuPont Merck is fostering enrollment in the trials with the aid of the Alzheimer's Association, a national support group for Alzheimer's patients and their families. The association, which is a clearinghouse for information on Phase III Alzheimer's drug trials in the U.S., has set up a toll-free number for inquiries about linopirine and will provide callers with a fact sheet on the drug and a list of participating trial centers. Phase II trials of the drug in approximately 500 patients were recently completed. These patients are not being included in Phase III study. The Phase II results showed good efficacy and safety profiles, DuPont Merck Central Nervous System Disease Research Director Errol de Souza, PhD, told an April 30 National Pharmaceutical Council meeting on Alzheimer's drug research. "The drug has a good range of efficacious doses [and] a good safety range in animals as well as humans," de Souza said. Linopirine, "both in rodents and in primates, as well as humans, shows an [electroencephalogram] profile of vigilance," de Souza told the NPC ("The Pink Sheet" May 6, p. 12). The announcement of the start-up of Phase III trials for linopirine comes just days before Warner-Lambert's Alzheimer's drug Cognex (tacrine) is scheduled to get a second hearing before FDA's Peripheral and Central Nervous System Drugs Advisory Committee on July 15. Cognex, the first cognition enhancing Alzheimer's drug to be reviewed by an FDA advisory committee, will be presented for a yes-or-no decision on a proposed Treatment IND protocol that would provide expanded availability of the drug in new clinical trials ("The Pink Sheet" July 8, T&G-3). At its March 15 meeting, the committee was unable to recommend Cognex for approval due to unresolved questions of safety and efficacy.

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