Baxter International Inc. (NYSE:BAX) today provided an update on its clinical program evaluating the use of its GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG outside the United States and Canada), for the treatment of mild to moderate Alzheimer's disease. The company plans to initiate a second, confirmatory Phase III trial in the first quarter of 2012, having satisfactorily completed a futility analysis in its first Phase III trial.
"Today, patients affected by neurological conditions like Alzheimer's disease have limited treatment options. If successful, Baxter's Phase III trials will support a regulatory filing for use of immunoglobulin therapy in the treatment of Alzheimer's disease," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business.
The second Phase III trial is identical in design to the first Phase III trial, and will assess the safety and effectiveness of GAMMAGARD LIQUID as a potential treatment for signs and symptoms associated with Alzheimer's disease. It is a global, multi-center clinical trial that will enroll approximately 400 patients and is expected to take an estimated three years to complete. Approximately 80 centers in North America, Europe, Japan and Australia will participate in the study. The primary endpoint of the study is to evaluate the effectiveness of GAMMAGARD LIQUID 10% on preserving cognitive performance and functional activities in patients with mild to moderate Alzheimer's disease, as compared to standard of care, over an 18-month period.
This second, confirmatory trial follows a separate, ongoing Phase III Gammaglobulin Alzheimer's Partnership (GAP) trial sponsored by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by the National Institutes of Health. Enrollment in the first Phase III trial was completed in June 2011 and the study's Data Safety Monitoring Board (DSMB) recently completed a futility analysis - an early analysis to determine if the trial should continue. A futility analysis is not intended to demonstrate achievement of efficacy endpoints.
"After reviewing the futility analysis, the DSMB stated the ongoing GAP study could continue without modification. We look forward to seeing the final data in 2013 regarding the trial's endpoints, specifically whether GAMMAGARD LIQUID 10% will be a viable option for the treatment of this disease," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business.
Baxter International Inc.