Summary
Not surprisingly, everything tried thus far to slow the relentless progression of Alzheimer's disease has failed. But if strong efficacy signals from two pilot studies and a recently completed Phase II trial of human immunoglobulin (IVIg) are confirmed in a Phase III trial scheduled to start next month, that string of failures will be coming to an abrupt end. The two NIH-supported pivotal trials will answer two questions: (1) is an age-related failure of natural antibody-mediated immunity important in the development of Alzheimer's disease, and (2) can this disease process be slowed by restoring therapeutic levels of antibodies that some older people no longer make enough of? With what we know about the role of beta-amyloid protein in Alzheimer's, and have learned from studies testing anti-beta amyloid monoclonal antibodies, and have seen in those three small IVIg trials , I wouldn't bet on another failure this time around.
Analysis
These pivotal IVIg/Alzheimer's studies for Baxter and other IVIg manufacturers -- CSL, Talecris, Grifols, Octapharma, Biotest, Kedrion and others -- can play out in unexpected ways over the next several years. Alzheimer's is no ordinary disease. And this is no ordinary drug development story.
