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Baxter and The Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimer's Disease
Date:8/28/2007

n Relkin and his colleagues at Weill Cornell Medical College in New York City. In this study, 24 patients with mild to moderate Alzheimer's disease were randomly assigned to receive GAMMAGARD Liquid, GAMMAGARD S/D or placebo (eight patients were treated with GAMMAGARD Liquid, eight patients were treated with GAMMAGARD S/D and eight patients received placebo) for six months. Cognitive, behavioral and functional measures were collected at baseline, three months and six months of treatment. The primary endpoints of the Phase II trial were cognitive function (as measured by ADAS-Cog score) and global function (as assessed by ADCS-CGIC rating). The pre-specified criterion for going forward with Phase III was a favorable outcome in IGIV-treated patients relative to those given placebo. Final results of the analysis of the Phase II study are expected later this year.

The Phase II study follows Dr. Relkin's earlier Phase I results in eight patients that were reported at the International Conference on Alzheimer's Disease in Madrid in July, 2006. Although these findings are promising, both studies were small and results must therefore be confirmed in a larger, sufficiently powered study.

The study protocol will be submitted to the U.S. Food and Drug Administration for review in the coming months with the intention of initiating patient recruitment early in 2008. The ADCS Phase III trial is sponsored jointly by the National Institutes of Health and Baxter. The trial will include approximately 35 leading academic centers in the U.S. that are members of ADCS.

GAMMAGARD LIQUID

[Immune Globulin Intravenous (Human)] 10%

GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Inform
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