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CHICAGO, July 30, 2008 – Today at the International Conference on Alzheimer’s Disease (ICAD) in Chicago, the nine-month interim results of the first U.S. double-blind, placebo-controlled Phase II clinical trial of Baxter’s GAMMAGARD S/D and GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)] (marketed as KIOVIG outside of the U.S.) for Alzheimer's disease will be announced.
Dr. Norman Relkin, lead investigator for the Phase II study, will present data from the nine-month interim analysis titled , Effects of uninterrupted intravenous immunoglobulin treatment of Alzheimer's disease for 9 months (poster), on Wednesday, July 30, 2008, 12:30 pm - 3:00 pm CDT. Dr. Relkin is a behavioral neurologist, neuroscientist and director of the Memory Disorders Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and associate professor of Clinical Neurology at Weill Cornell Medical College in New York City.
The primary endpoints of the study are cognitive function, measured by the ADAS-cog, and global impression of change, as assessed by the ADCS-CGIC. Nine-month data improved significantly over six-month data on each of the two metrics measured (the difference between ADAS-cog score of IGIV versus initially placebo-treated patients at nine months increased 5.4 points, compared to 2.6 points at six months, CGIC score compared to placebo at nine months increased 1.4 points compared to 1.2 points at six months). These results further support Baxter’s decision to move into Phase III clinical testing in order to assess safety and efficacy. Cornell will present additional data starting at 12:30 pm CDT.
Baxter supported the study and provided IGIV in both a liquid and solvent-detergent treated lyophilized form for the trial. GAMMAGARD S/D and GAMMAGARD LIQUID contain a broad spectrum of immunoglobulins (antibodies), and are indicated for the treatment of patients with primary immunodeficiency disorders.
About GAMMAGARD LIQUID and GAMMAGARD S/D
GAMMAGARD LIQUID
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, 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.baxter.com/products/biopharmaceuticals/downloads/gamliquid_PI.pdf
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.
For full prescribing information, please visit: http://www.baxter.com/products/biopharmaceuticals/downloads/gammagard_us_pi.pdf
About Baxter
Baxter International Inc. (NYSE:BAX) 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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