Phase II GAMMAGARD clinical study for Alzheimer's disease: 18-month results announced

Baxter International Inc. (NYSE: BAX) and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimer's disease. This marked the first announcement of clinical trial results measuring function and cognition in patients who received uninterrupted GAMMAGARD for a period of 18 months.

“The important next step is to fully enroll and complete the ongoing Phase III study of GAMMAGARD, in hope of confirming these Phase II findings and fully understanding GAMMAGARD's potential benefit in Alzheimer's disease.”

The study measured function using the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC) and measured cognition using the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog). After 18 months, patients>

The data are being presented at the American Academy of Neurology (AAN) annual meeting in Toronto by the principal investigator for the trial, Dr. Norman Relkin, and Dr. Diamanto Tsakanikas. Dr. Relkin is the director of the Memory Disorders Program and a behavioral neurologist and neuroscientist at the New York-Presbyterian Hospital/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College. Dr. Tsakanikas is a clinical assistant attending neuropsychologist at New York-Presbyterian Hospital/Weill Cornell Medical Center and instructor of neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College. The study was supported by Baxter, the Citigroup Foundation, and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

Being presented for the first time, MRI analyses showed that patients who received GAMMAGARD continuously for 18 months experienced decreased mean annual ventricular enlargement rates in their brains (6.7%), compared to control patients who initially received placebo (12.3%,>

"The cognitive and functional outcomes and neuroimaging results from this 18-month Phase II study in participants receiving GAMMAGARD continuously clearly support continued evaluation for Alzheimer's disease in a larger number of patients," said Dr. Paul Aisen, director of the Alzheimer's Disease Cooperative Study. "The important next step is to fully enroll and complete the ongoing Phase III study of GAMMAGARD, in hope of confirming these Phase II findings and fully understanding GAMMAGARD's potential benefit in Alzheimer's disease."

The ongoing Phase III study of GAMMAGARD, called the Gammaglobulin Alzheimer's Partnership (GAP) Study, is designed to evaluate the potential of GAMMAGARD for mild-to-moderate Alzheimer's disease. The study includes 35 actively enrolling sites at leading academic centers in the United States that are members of The Alzheimer's Disease Cooperative Study (ADCS), with an additional 12 sites pending in the U.S. and Canada. Study participants will be evaluated on clinical scales for cognition and function over 18 months. Biomarker and neuroimaging tests will be performed in order to measure GAMMAGARD's potential effect on disease progression. Alzheimer's patients and their caregivers can find study details and learn more about participation by calling 1-877-55-GAPSTUDY (1-877-554-2778). The study is sponsored by Baxter and partially funded by the National Institutes of Health (NIH) through the Alzheimer's Disease Cooperative Study (ADCS).

Baxter plans to initiate a second, concurrent Phase III study of GAMMAGARD for mild-to-moderate Alzheimer's disease to confirm the Phase II results in more patients. The Phase II results represent the first study in Alzheimer's disease where all three measures - cognitive, functional and neuroimaging - had positive data and were statistically significant.

"Baxter is encouraged by the 18-month Phase II results for GAMMAGARD for Alzheimer's disease. Based on the strength of these data, we plan to initiate a second Phase III study of GAMMAGARD for Alzheimer's disease," said Hartmut Ehrlich, M.D., vice president of research and development for Baxter BioScience. "The new study will collect additional evidence to support GAMMAGARD's use in mild-to-moderate Alzheimer's disease and, with our ongoing Phase III study, support filing for registration in this indication. We will work closely with FDA on appropriate next steps and look forward to making continued progress studying GAMMAGARD's potential benefit in Alzheimer's disease and other neurology indications."

Baxter's commitment to advancing the scientific and clinical knowledge around GAMMAGARD in several neurological applications includes multiple late-stage clinical trials. In addition to the ongoing Phase III trial studying GAMMAGARD LIQUID in Alzheimer's disease, Baxter is currently enrolling patients into a Phase III trial studying GAMMAGARD LIQUID in multifocal motor neuropathy (MMN). A Phase III trial studying GAMMAGARD LIQUID in chronic inflammatory demyelinating polyneuropathy (CIDP) is planned to begin later this year.