Baxter, ADCS to Study Gammagard Liquid

Baxter and the Alzheimer’s Disease Cooperative Study (ADCS) announced the decision to pursue a multicenter U.S. Phase III study evaluating the role of Gammagard Liquid, an intravenous immunoglobulin preparation, for the treatment of patients with mild-to-moderate Alzheimer’s disease.

Gammagard Liquid (Immune Globulin Intravenous) contains a broad spectrum of antibodies, and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency, Baxter and ADCS said.

According to Baxter and ADCS, the decision to pursue the Phase III study is based on the results of two completed open-label clinical studies, and the preliminary analysis of interim data from a double-blind, placebo-controlled Phase II study.
 
The study protocol will be submitted to the FDA for review in the coming months with the intention of initiating patient recruitment early in 2008.