Prana to start phase 2a Alzheimer's trial with PBT2

By Elaine Rigoli

Tampa, Fla., May 11 - Prana Biotechnology Ltd. announced plans to move forward with a phase 2a clinical trial of its proprietary lead compound, PBT2, in patients with Alzheimer's disease.

The study will evaluate the safety and tolerability of PBT2, as well as measure the drug's mechanism of action and indicators of potential efficacy in Alzheimer's disease. Enrollment will commence in the fourth quarter.

Results are expected to be reported by the end of 2007, the company said in a news release.

The phase 2a study is a randomized, double-blind, placebo-controlled design, in which Alzheimer's disease patients will receive three months of either one of three oral doses of PBT2, or a placebo.

The study will investigate the ability of PBT2 to affect multiple cerebrospinal fluid and blood biomarkers of Alzheimer's disease during the treatment period.

Outcomes will include measures of cerebrospinal fluid alpha, beta and tau levels as well as neurocognitive and behavioral changes, the release said.

Prana said it will use data from this phase 2a trial, along with data from a planned larger, pivotal clinical trial, to capitalize on new European Medicines Agency regulations that allow for conditional marketing authorization of treatments for seriously debilitating or life-threatening diseases for which there are otherwise limited treatment options.

Prana commercializes research into Alzheimer's disease and is based in Melbourne, Australia.

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