Avicena data shows ALS-02 same as placebo in phase 3 ALS trial

By Elaine Rigoli

Tampa, Fla., May 9 - The Avicena Group, Inc. announced results of a phase 3 trial that showed no statistically significant difference between ALS-02 and a placebo with regard to the study's primary and secondary endpoints.

Avicena's phase 3 study of ALS-02 was a multi-center, double-blind, placebo-controlled, randomized trial designed to evaluate the safety and efficacy of the compound at a dose of 5 grams per day for nine months.

However, in a separate analysis when mortality data was combined and analyzed with mortality data from a second study of ALS-02 previously conducted by the North East ALS Consortium, the analysis demonstrated a positive trend toward decreased mortality in subjects receiving ALS-02, according to a news release.

A comprehensive meta analysis is also being planned to combine data from all formal trials in which ALS-02 was used as an experimental therapeutic agent in ALS.

Upon completion of the meta analysis, Avicena intends to discuss the findings with the Food and Drug Administration in order to determine the appropriate next development steps for ALS-02, a proprietary therapeutic that incorporates an ultra-pure, clinical form of creatine. The compound was granted orphan drug designation by the FDA in 2002.

Based in Palo Alto, Calif., Avicena is a biotechnology company that develops and commercializes therapeutic products that regulate the energy processes that occur within human cells.

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