Baxter International
Inc. (NYSE: BAX) and The Alzheimer's Disease Cooperative Study (ADCS) group
today announced the decision to pursue a multi-center U.S. Phase III study
evaluating the role of Gammagard Liquid [Immune Globulin Intravenous
(Human)] (IGIV), an intravenous immunoglobulin preparation, for the
treatment of patients with mild to moderate alzheimer's disease. GAMMAGARD
Liquid contains a broad spectrum of immunoglobulins (antibodies), and is
indicated as an immunoglobulin replacement therapy in patients with primary
immunodeficiency.
GAMMAGARD Liquid is processed from large pools of human plasma. IGIV
has been used for almost three decades to treat primary immunodeficiency.
IGIV is not currently approved for the treatment of Alzheimer's disease,
and to date has not been established to be effective in this indication.
The rationale for testing IGIV as a possible treatment for Alzheimer's is
based on the presence of natural antibodies that are directed against
several forms of beta amyloid. Beta amyloid is a protein found in plaques
that accumulate in the brains of patients with Alzheimer's disease, and is
considered to play a key role in the cognitive decline observed in these
patients. Treatment with naturally occurring antibodies against beta
amyloid contained in IGIV may result in clearance of beta amyloid from the
brain and dissolution of plaques.
The decision to pursue the Phase III study is based on the results of
two completed open-label clinical studies, and the preliminary analysis of
interim data from a double-blind, placebo-controlled phase II study by Dr.
Norman Relkin and his colleagues at Weill Cornell Medical College in New
York City. In this study, 24 patients with mild to moderate Alzheimer's
disease were randomly assigned to receive GAMMAGARD Liquid, GAMMAGARD S/D
or placebo (eight patients were treated with GAMMAGARD Liquid, eight
patients were treated with GAMMAGARD S/D and eight patients received
placebo) for six months. Cognitive, behavioral and functional measures were
collected at baseline, three months and six months of treatment. The
primary endpoints of the Phase II trial were cognitive function (as
measured by ADAS-Cog score) and global function (as assessed by ADCS-CGIC
rating). The pre-specified criterion for going forward with Phase III was a
favorable outcome in IGIV-treated patients relative to those given placebo.
Final results of the analysis of the Phase II study are expected later this
year.
The Phase II study follows Dr. Relkin's earlier Phase I results in
eight patients that were reported at the International Conference on
Alzheimer's Disease in Madrid in July, 2006. Although these findings are
promising, both studies were small and results must therefore be confirmed
in a larger, sufficiently powered study.
The study protocol will be submitted to the U.S. Food and Drug
Administration for review in the coming months with the intention of
initiating patient recruitment early in 2008. The ADCS Phase III trial is
sponsored jointly by the National Institutes of Health and Baxter. The
trial will include approximately 35 leading academic centers in the U.S.
that are members of ADCS.
GAMMAGARD LIQUID
[Immune Globulin Intravenous (Human)] 10% 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.
Important Safety Information
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, e.g. 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).
GAMMAGARD S/D
[Immune Globulin Intravenous (Human)]
GAMMAGARD S/D 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.
GAMMAGARD S/D must not be used in patients with selective IgA
deficiency (IgA, 0.05 g/L) where the IgA deficiency is the only abnormality
of concern.
Important Safety Information
Patients may experience severe hypersensitivity reactions or
anaphylaxis in the setting of detectable IgA levels following infusion of
GAMMAGARD S/D.
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.
GAMMAGARD S/D does not contain sucrose.
GAMMAGARD S/D is made from human plasma. It may carry a risk of
transmitting infectious agents, e.g. viruses, and theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
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.
Certain components used in the packaging of GAMMAGARD S/D contain
natural rubber latex.
IGIV products can contain blood group antibodies that may cause a
positive direct antiglobulin reaction and, rarely, hemolysis.
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.
Various minor reactions, such as mild to moderate hypotension,
headache, fatigue, chills, backache, leg cramps, lightheadedness, fever,
urticaria, flushing, slight elevation of blood pressure, nausea and
vomiting, may occasionally occur.
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other conditions. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to make
a meaningful difference in patients' lives.
This release includes forward-looking statements concerning IGIV
relating to clinical trials and their timing, as well as potential future
uses of the product. The statements are based on assumptions about many
important factors, including the following, which could cause actual
results to differ materially from those in the forward-looking statements:
continuing review of preliminary trial data and the limited number of
patients studied to date; additional regulatory and other steps required
prior to the initiation of the larger study described in the release; and
other risks identified in the company's most recent filing on Form 10-Q and
other SEC filings, all of which are available on the company's web site.
The company does not undertake to update its forward-looking statements.
Baxter International Inc.
baxter
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