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Baxter initiates phase III study to evaluate Gammagard Liquid for Alzheimer’s disease

This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for GAMMAGARD LIQUID as a potential treatment for Alzheimer’s disease.

This clinical trial is active but not yet actively recruiting participants. This is the official name of the clinical trial, Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in PID Subjects . You can learn more about the trial including eligibility requirements and locations by following the link. We will alert you when they start actively recruiting patients.

More information GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

Baxter Initiates GAMMAGARD LIQUID Phase III Trial for the Treatment of Alzheimer’s Disease

Baxter Healthcare Corporation today announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)], marketed as KIOVIG in European Union, for the treatment of mild-to-moderate Alzheimer’s disease. This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for GAMMAGARD LIQUID as a potential treatment for the disease.

The Phase III trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, ages 50 to 89 years old, with dementia of mild-to-moderate severity. The study will determine whether GAMMAGARD LIQUID treatment results in a significantly slower rate of decline of cognitive and other functions compared to placebo. Approximately 40 U.S. leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks.

Efficacy will be assessed by two primary endpoints:

* Cognitive outcomes using the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and
* Global clinical outcome as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC).

Secondary endpoints to be assessed at 18 months include behavioral, functional and quality of life outcome measures. Other secondary endpoints will include several plasma, cerebrospinal fluid, and imaging biomarkers to assess disease progression and response to therapy.

The trial is sponsored by Baxter and partially funded by the National Institutes of Health (NIH) through the Alzheimer’s Disease Cooperative Study (ADCS). The ADCS is a cooperative agreement between the National Institute of Aging and the University of California San Diego (UCSD). The ADCS was developed in response to a perceived need to advance research in the development of therapies that might be useful for treating patients with Alzheimer’s disease. The trial will be managed by Paul Aisen, M.D., director of the Alzheimer’s Disease Cooperative Study and professor, department of Neurosciences, UCSD. The involvement of the ADCS and NIH in the conduct of the Phase III trial should help ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD LIQUID in the treatment of Alzheimer’s disease.

The project leader for the trial is Norman Relkin, M.D., PhD, director of the Memory Disorders Program and behavioral neurologist and neuroscientist at New York-Presbyterian/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College in New York City. Dr. Relkin is also the lead investigator for the Phase I and II studies with GAMMAGARD LIQUID for the same indication.

GAMMAGARD LIQUID contains a broad spectrum of immunoglobulins (antibodies). The therapy is approved for use as an immunoglobulin replacement therapy that boosts the immune system in patients with primary immunodeficiency disorders. The precise mechanisms of the therapy’s effects in Alzheimer’s disease are not yet known.

Original content at the Alzheimer’s Reading Room.

 

Study Suggests GAMMAGARD LIQUID May Target the Primary Pathway Involved in Alzheimer’s Disease

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.

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

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 primaryculprit 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.

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