Study Suggests GAMMAGARD LIQUID May Target the Primary Pathway Involved in
Alzheimer's Disease
Laboratory study shows naturally occurring antibodies contained in GAMMAGARD
LIQUID may bind to the primary culprit for Alzheimer's disease
CHICAGO, April 15 /PRNewswire-FirstCall/ -- 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.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID
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
http://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 The University of Tennessee Health Science Center
As the flagship statewide academic health system, the UT Health Science
Center is focused on a four-tier mission of education, research, clinical care
and public service, all in support of a single goal: to improve the health of
Tennesseans. Offering a broad range of postgraduate training opportunities,
the main campus, which includes six colleges, is located in Memphis. UTHSC has
additional College of Medicine and College of Pharmacy campus locations in
Knoxville and a College of Medicine campus in Chattanooga. For more
information, visit www.utmem.edu.
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.
SOURCE Baxter International Inc.
Media, Anne Manning of University of Tennessee, +1-901-448-4072; or
Christopher Bona, +1-847-948-2815, or Laura Grossmann, +1-847-948-3026, both
of Baxter, or Investors, Mary Kay Ladone, +1-847-948-3371, or Clare Trachtman,
+1-847-948-3085, both of Baxter
