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Laura Grossmann, (847) 948-3026
Baxter
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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, 2008 – 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,
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,
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.
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
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
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.
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This study 
quantifies the economic impact of the UTHSC on the economy of the state of Tennessee for FY2010.
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