Baxter and The Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimer...( Preliminary Phase II Results Enco...),Health

Preliminary Phase II Results Encouraging and Support Phase III Study

DEERFIELD, Ill., Aug. 28 /PRNewswire-FirstCall/ -- Baxter International Inc. (NYSE: BAX) and The Alzheimer's Disease Cooperative Study (ADCS) group today announced the decision to pursue a multi-center U.S. Phase III study evaluating the role of Gammagard Liquid [Immune Globulin Intravenous (Human)] (IGIV), an intravenous immunoglobulin preparation, for the treatment of patients with mild to moderate alzheimer's disease. GAMMAGARD Liquid contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency.

GAMMAGARD Liquid is processed from large pools of human plasma. IGIV has been used for almost three decades to treat primary immunodeficiency. IGIV is not currently approved for the treatment of Alzheimer's disease, and to date has not been established to be effective in this indication. The rationale for testing IGIV as a possible treatment for Alzheimer's is based on the presence of natural antibodies that are directed against several forms of beta amyloid. Beta amyloid is a protein found in plaques that accumulate in the brains of patients with Alzheimer's disease, and is considered to play a key role in the cognitive decline observed in these patients. Treatment with naturally occurring antibodies against beta amyloid contained in IGIV may result in clearance of beta amyloid from the brain and dissolution of plaques.

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 by Dr. Norma
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