Liquid immunoglobulin (Gammagard) helps preventing brain shrinkage in Alzheimer’s patients, claims Baxter

Intravenous human immune globulin (Gammagard) developed by Baxter Inc could help preventing brain shrinkage in Alzheimer’s disease patients.

Clinical trial results measuring function and cognition in patients who received uninterrupted Gammagard for a period of 18 months have been announced by Baxter International Inc and New York-Presbyterian Hospital/Weill Cornell Medical Center.

Gammagard is marketed as Kiovig outside of the US for mild-to-moderate Alzheimer’s disease.

The phase 2 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 who received Gammagard continuously averaged approximately 1.36 points higher than patients who initially received placebo.

Patients who received Gammagard continuously declined by approximately 9.15 fewer ADAS-Cog points than patients who initially received placebo (approximately 6 point decline vs. 15 point decline.

Patients who received Gammagard continuously for 18 months experienced lower mean annual whole brain atrophy rates, compared to control patients who initially received placebo.

“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 ongoing phase 3 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 visiting www.GAPSTUDY.com or 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 2 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.

Baxter is currently enrolling patients into another phase 3 trial studying Gammagard Liquid in multifocal motor neuropathy (MMN). A phase 3 trial studying Gammagardd liquid in chronic inflammatory demyelinating polyneuropathy (CIDP) is planned to begin later this year.
Gammagard liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include, but are not limited to, congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

In February, Swiss biopharmaceutical company Octapharma reported that intravenous immunoglobin octagam could open up a new treatment modality to prevent several diseases related to primary immune deficiency including Alzheimers’ disease,.

Octapharma AG has started the first of a series of Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG).

The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency.

octagam, Octapharma’s current leading IVIG (an immune globulin human solution for intravenous administration) is registered in about 60 countries, including the EU and the US.

The Phase III study in primary immune deficiency represents the start of a series of planned studies to investigate Octapharma’s new 10% IVIG for a range of neurologic and haematological conditions including idiopathic thrombocytopenic purpura (ITP), Guillain-Barré(C) syndrome (GBS) and Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

New York-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products for hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.

Baxter has expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.