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Study Suggests GAMMAGARD LIQUID May Target Pathway in Alzheimer’s


UTHSC and Baxter International Inc. announce data from a laboratory study shows naturally occurring antibodies contained in GAMMAGARD LIQUID may bind to the primary culprit for Alzheimer’s disease.

The University of Tennessee Health Science Center and Baxter International Inc. (NYSE: BAX) today announced data from a laboratory study demonstrating natural antibodies contained in GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (IGIV), marketed as KIOVIG in the European Union, a plasma-derived antibody replacement therapy indicated for primary immunodeficiency disorders and being studied in Alzheimer’s disease, binds directly to multiple aggregated, or clustered, forms of the beta-amyloid peptide molecule. The beta-amyloid molecule may contribute to beta-amyloid plaques, which are thought to be the primary culprit causing Alzheimer’s disease. The results of this in vitro (laboratory) study were presented by Dr. Brian O’Nuallain, assistant professor, UT Medical Center, Knoxville, University of Tennessee Health Science Center at the American Academy of Neurology (AAN) Annual Meeting.

Previous clinical studies suggest that antibody-based immunotherapy may boost the body’s own immune response to reduce beta-amyloid, the protein responsible for plaque formation commonly found in the brains of Alzheimer’s disease patients. In addition, recent laboratory research suggests that specific forms of beta-amyloid — oligomers and fibrils that are aggregates or clusters of beta-amyloid — may be toxic to the neurological system and lead to the progression of Alzheimer’s disease.

“IGIV therapy may contain antibodies that possibly have strong binding characteristics to several aggregated forms of the beta-amyloid peptide that are believed to cause Alzheimer’s disease,” said Dr. O’Nuallain. “These initial findings could be promising in Alzheimer’s disease research using naturally occurring antibodies.”

The oral presentation at AAN, entitled “Affinity Isolation and Characterization of Abeta Conformer-Reactive Antibodies Contained in Human Immune Globulin (IVIG),” showed that GAMMAGARD contains naturally occurring antibodies that directly bind to different forms of beta-amyloid protein, including oligomers and fibrils.

“Observations from this study provide insight into how GAMMAGARD LIQUID may be of potential clinical benefit for Alzheimer’s patients,” said Dave Morgan, director of Neuroscience Research, University of South Florida. “This study suggests that GAMMAGARD LIQUID may target the primary pathway involved in Alzheimer’s disease and justifies additional studies to evaluate whether GAMMAGARD LIQUID can effectively reverse the effects of Alzheimer’s disease.”

According to the Alzheimer’s Association, an estimated 5.2 million Americans have Alzheimer’s disease, including one out of eight people age 65 and older, and the number of new cases per year is expected to grow to 454,000 by 2010. No cure currently exists that can halt or delay the brain deterioration associated with Alzheimer’s disease, but new research shows encouraging results. The study’s findings showed how the mechanism of action of GAMMAGARD may work on multiple forms of the beta- amyloid peptide to protect the human brain from dementia and may facilitate the development of treatment for patients with Alzheimer’s disease.

Additional GAMMAGARD Trials in Alzheimer’s Disease

At the AAN meeting, other studies will be presented on the use of GAMMAGARD in Alzheimer’s disease. One oral presentation scheduled for April 17 — “A Double-Blind, Placebo-Controlled, Phase II Clinical Trial of Intravenous Immunoglobulin (IVIG) for Treatment of Alzheimer’s Disease” — will discuss the evaluation of the efficacy, tolerability and safety of GAMMAGARD in the treatment of mild to moderate stage Alzheimer’s disease.

The oral presentation, “Intravenous Immunoglobulin Increases Brain Glucose Metabolism in Alzheimer Disease,” will also be presented on April 17 and will discuss the analysis of brain activity using imaging data. The brain metabolism results were based on serial Positron Emission Tomography (PET) scans, an imaging technique sometimes used in the diagnosis of Alzheimer’s disease.

Further, Baxter and The Alzheimer’s Disease Cooperative Study (ADCS) group announced a decision to pursue a multi-center U.S. Phase III study evaluating the role of GAMMAGARD. The study design is undergoing review with the U.S. Food and Drug Administration with the intention of initiating patient recruitment later in 2008. The trial is expected to include approximately 35 leading academic centers in the United States that are members of ADCS.

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Components used in the packaging of this product are latex-free.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

For full prescribing information, please visit https://www.gammagardliquid.com.

About Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia, a clinical condition, which involves the decline or loss of memory and other cognitive abilities. A progressive and ultimately fatal disease marked by severe brain tissue deterioration, Alzheimer’s disease initially involves the parts of the brain that control thought, memory and language. The number of new Alzheimer’s disease cases diagnosed annually is expected to reach 959,000 new cases a year by 2050. By that time, the number of people age 65 and older with Alzheimer’s disease could reach as high as 16 million.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.