Baxter to initiate phase III Gammagard trial

Baxter International has announced that it is to initiate a multi-centre phase III clinical study for the evaluation of Gammagard liquid [immune globulin intravenous (human)] (IGIV) as a treatment for moderate Alzheimer’s disease patients.

The firm has elected to pursue this study in conjunction with the Alzheimer’s Disease Cooperative Study group following the presentation of results of two open-label clinical trials and the preliminary analysis of a phase II study conducted by Dr Norman Relkin.

Gammagard liquid is an intravenous immunoglobulin preparation processed from large pools of human plasma indicated as an immunoglobulin replacement treatment for primary immunodeficiency patients.

“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,” Baxter reports.

The firm reports that this protein is present in plaques that are detected in accumulated form in the brains of Alzheimer’s disease patients, with beta amyloid believed to play a vital role in the cognitive decline of these individuals.

Last week, Baxter announced the launch of its Gardian initiative to guarantee the supply of Gammagard Liquid and Gammagard S/D to patients requiring the treatment, regardless of changes to providers or sites of care.