Neurochem to start phase 3 extension study for Alzhemed for Alzheimer's

By Lisa Kerner

Erie, Pa., Feb. 8 - Neurochem Inc. said it is beginning an 18-month open-label extension study for its ongoing North American phase 3 clinical trial for Alzhemed (tramiprosate), its investigational product candidate for the treatment of Alzheimer's disease.

Neurochem is currently conducting a double-blind, randomized, placebo-controlled 18-month phase 3 clinical trial in 1,052 mild-to-moderate Alzheimer's disease patients at close to 70 sites across the United States and Canada. The company said 338 patients have completed 12 months on study medication. The trial is scheduled to be completed by January 2007.

"Alzhemed has shown promising results in clinical trials as a drug that may favorably influence the disease process," Dr. Paul Aisen, Alzhemed's principal investigator for the U.S. clinical sites, said in the release.

"Furthermore, our experience with patients receiving Alzhemed for up to 20 months in an open-label phase 2 extension study has been encouraging."

Neurochem is also actively pursuing the advancement of the phase 3 clinical trial for Alzhemed in Europe, which began in September.

The ongoing multi-center, randomized, double-blind, placebo-controlled and parallel designed study will investigate the safety and efficacy of Alzhemed in treating Alzheimer's disease, with about 930 mild-to-moderate Alzheimer's disease patients expected to take part. Patients will receive either a placebo or one of two different dose levels of Alzhemed for a period of 18 months, in addition to their regular treatment.

Alzhemed is a small, orally administered molecule designed to modify the course of Alzheimer's disease as an amyloid(B) antagonist by binding to soluble amyloid(B) peptide to inhibit or reduce amyloid deposition.

Neurochem, based in Laval, Quebec, is focused on the development and commercialization of innovative therapeutics to addresses critical unmet medical needs.

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