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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.

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

Results of 9-Month Phase II Study

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.


NewYork-Presbyterian/Weill Cornell Announces Results of 9-Month Phase II Study of GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

NewYork-Presbyterian Hospital/Weill Cornell Medical Center announced today the nine-month interim results of an ongoing Phase II clinical trial of GAMMAGARD Intravenous Immunoglobulin (IGIV) for Alzheimer’s disease at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) in Chicago.

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

Just last April, at the American Academy of Neurology (AAN) meeting in Chicago, the six-month outcomes of the double-blind, placebo-controlled Phase II trial were presented. Now, interim data from the extension of that study show persistence of benefits for Alzheimer’s patients treated continuously over 9 months. This is the first study to show persistence of benefits for Alzheimer’s from IGIV with continuous treatment for 9 months. Previous studies discontinued therapy after 6 months.

The lead researcher for the trial is Dr. Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is director of the Memory Disorders Program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Clinical Neurology at Weill Cornell Medical College in New York City.

Working in collaboration with Dr. Relkin is Dr. Diamanto Tsakanikas, the neuropsychologist for the Phase II study. Dr. Tsakanikas is Clinical Assistant Attending Neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an Instructor of Neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College.

Baxter International Inc. supported the study and provided GAMMAGARD Liquid and GAMMAGARD S/D for the trial. GAMMAGARD contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency disorders.

In the double-blind, placebo-controlled Phase II study, 24 patients in the United States with mild to moderate Alzheimer’s disease were randomly assigned to receive GAMMAGARD LIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo (eight patients). In the open-label extension of this study, all patients were treated for a total of 18 months. The study included a comparison of four dosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every month.

Cognitive, behavioral and functional measures were collected at baseline and every three months thereafter. The primary endpoints of the Phase II trial were cognitive function, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and global function, as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (CGIC). Safety and tolerability of IGIV treatment in Alzheimer’s patients were also assessed relative to placebo. Secondary endpoints included effects on biomarkers related to beta amyloid, a peptide related to Alzheimer’s disease.

In today’s presentation at ICAD, Dr. Relkin reported that subjects who received uninterrupted IGIV therapy for 9 months demonstrated significantly better cognitive and overall clinical outcomes compared to initially placebo-treated subjects. Dr. Relkin also reported that uninterrupted treatment with IGIV resulted in further improvements in activities of daily living.

Statistically significant differences favoring IGIV treatment were observed on the CGIC at 3, 6 and 9 months. After nine months, the group of patients treated with GAMMAGARD averaged 1.4 points higher than initially placebo-treated patients on the CGIC, a commonly used measure of overall outcome in Alzheimer’s clinical trials. At six months, the same group of patients had averaged 1.2 points higher than placebo-treated patients on the CGIC.

On the ADAS-Cog, a test of cognition, change scores numerically favored the IGIV-treatment at 3, 6 and 9 months, with the difference reaching statistical significance at 3 and 9 months. The average change in ADAS-Cog score at nine months of treatment favored treatment with GAMMAGARD by 5.4 ADAS points. The average change in ADAS-Cog score at six months of treatment had favored GAMMAGARD by 2.6 ADAS points. In an analysis by dose arm, subjects receiving 0.4g IGIV/kg/2 weeks improved over baseline on ADAS-Cog scores in 4 of 4 cases at 9 months. None of the subjects given placebo initially showed comparable improvements.

The scientists also measured activities of daily living (ADL) — the actual performance of each subject in common daily activities, as reported by caregivers. ADL is broken down into three increasing levels of severity: 1) independence, 2) supervision/required verbal reminders or instruction, and 3) physical assistance for daily tasks — including eating, toileting, bathing, grooming, dressing, reading, travel and using common household appliances. The research team found that experimental subjects either slightly improved or slightly declined over the study period. However, subjects in the placebo group showed a greater drop in ADL score.

The IGIV group showed minimal decline in carrying out daily tasks and performed better than initially placebo–treated patients on measures of activities of daily living. On average, there was a 7-point difference (-9.6 ADL point score in the placebo group compared to -2.5 ADL point score in the experimental group) between the IGIV (at all doses administered) and the placebo group. There was an 11-point difference between the 9-month performance of the IGIV group (+2 ADL points) and that of the placebo group (-9 ADL points). “Effects on daily function of this magnitude can make a difference in the lives of Alzheimer’s patients and their caregivers,” Dr. Tsakanikas commented.

Last year, in August 2007, NewYork-Presbyterian/Weill Cornell announced preliminary results of the Phase II study, indicating that the study provided further encouragement for carrying out a Phase III trial.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows Dr. Relkin’s earlier Phase I results in eight patients that were recently published in the journal Neurobiology of Aging (Feb. 2008). Although the findings of the Phase I and II trials are encouraging, both studies were small and must be evaluated in larger, sufficiently powered studies.

The Phase III trial will be sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare, and additional studies may be required. The study protocol was submitted to the U.S. Food and Drug Administration for review, with the intention of initiating patient recruitment later this year. The trial will include about 35 leading academic centers in the United States that are members of The Alzheimer’s Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial will ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD in the treatment of Alzheimer’s patients.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org and http://www.med.cornell.edu.

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

Results of 9-Month Phase II Study

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.


NewYork-Presbyterian/Weill Cornell Announces Results of 9-Month Phase II Study of GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

NewYork-Presbyterian Hospital/Weill Cornell Medical Center announced today the nine-month interim results of an ongoing Phase II clinical trial of GAMMAGARD Intravenous Immunoglobulin (IGIV) for Alzheimer’s disease at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) in Chicago.

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

Just last April, at the American Academy of Neurology (AAN) meeting in Chicago, the six-month outcomes of the double-blind, placebo-controlled Phase II trial were presented. Now, interim data from the extension of that study show persistence of benefits for Alzheimer’s patients treated continuously over 9 months. This is the first study to show persistence of benefits for Alzheimer’s from IGIV with continuous treatment for 9 months. Previous studies discontinued therapy after 6 months.

The lead researcher for the trial is Dr. Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is director of the Memory Disorders Program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Clinical Neurology at Weill Cornell Medical College in New York City.

Working in collaboration with Dr. Relkin is Dr. Diamanto Tsakanikas, the neuropsychologist for the Phase II study. Dr. Tsakanikas is Clinical Assistant Attending Neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an Instructor of Neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College.

Baxter International Inc. supported the study and provided GAMMAGARD Liquid and GAMMAGARD S/D for the trial. GAMMAGARD contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency disorders.

In the double-blind, placebo-controlled Phase II study, 24 patients in the United States with mild to moderate Alzheimer’s disease were randomly assigned to receive GAMMAGARD LIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo (eight patients). In the open-label extension of this study, all patients were treated for a total of 18 months. The study included a comparison of four dosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every month.

Cognitive, behavioral and functional measures were collected at baseline and every three months thereafter. The primary endpoints of the Phase II trial were cognitive function, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and global function, as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (CGIC). Safety and tolerability of IGIV treatment in Alzheimer’s patients were also assessed relative to placebo. Secondary endpoints included effects on biomarkers related to beta amyloid, a peptide related to Alzheimer’s disease.

In today’s presentation at ICAD, Dr. Relkin reported that subjects who received uninterrupted IGIV therapy for 9 months demonstrated significantly better cognitive and overall clinical outcomes compared to initially placebo-treated subjects. Dr. Relkin also reported that uninterrupted treatment with IGIV resulted in further improvements in activities of daily living.

Statistically significant differences favoring IGIV treatment were observed on the CGIC at 3, 6 and 9 months. After nine months, the group of patients treated with GAMMAGARD averaged 1.4 points higher than initially placebo-treated patients on the CGIC, a commonly used measure of overall outcome in Alzheimer’s clinical trials. At six months, the same group of patients had averaged 1.2 points higher than placebo-treated patients on the CGIC.

On the ADAS-Cog, a test of cognition, change scores numerically favored the IGIV-treatment at 3, 6 and 9 months, with the difference reaching statistical significance at 3 and 9 months. The average change in ADAS-Cog score at nine months of treatment favored treatment with GAMMAGARD by 5.4 ADAS points. The average change in ADAS-Cog score at six months of treatment had favored GAMMAGARD by 2.6 ADAS points. In an analysis by dose arm, subjects receiving 0.4g IGIV/kg/2 weeks improved over baseline on ADAS-Cog scores in 4 of 4 cases at 9 months. None of the subjects given placebo initially showed comparable improvements.

The scientists also measured activities of daily living (ADL) — the actual performance of each subject in common daily activities, as reported by caregivers. ADL is broken down into three increasing levels of severity: 1) independence, 2) supervision/required verbal reminders or instruction, and 3) physical assistance for daily tasks — including eating, toileting, bathing, grooming, dressing, reading, travel and using common household appliances. The research team found that experimental subjects either slightly improved or slightly declined over the study period. However, subjects in the placebo group showed a greater drop in ADL score.

The IGIV group showed minimal decline in carrying out daily tasks and performed better than initially placebo–treated patients on measures of activities of daily living. On average, there was a 7-point difference (-9.6 ADL point score in the placebo group compared to -2.5 ADL point score in the experimental group) between the IGIV (at all doses administered) and the placebo group. There was an 11-point difference between the 9-month performance of the IGIV group (+2 ADL points) and that of the placebo group (-9 ADL points). “Effects on daily function of this magnitude can make a difference in the lives of Alzheimer’s patients and their caregivers,” Dr. Tsakanikas commented.

Last year, in August 2007, NewYork-Presbyterian/Weill Cornell announced preliminary results of the Phase II study, indicating that the study provided further encouragement for carrying out a Phase III trial.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows Dr. Relkin’s earlier Phase I results in eight patients that were recently published in the journal Neurobiology of Aging (Feb. 2008). Although the findings of the Phase I and II trials are encouraging, both studies were small and must be evaluated in larger, sufficiently powered studies.

The Phase III trial will be sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare, and additional studies may be required. The study protocol was submitted to the U.S. Food and Drug Administration for review, with the intention of initiating patient recruitment later this year. The trial will include about 35 leading academic centers in the United States that are members of The Alzheimer’s Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial will ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD in the treatment of Alzheimer’s patients.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org and http://www.med.cornell.edu.

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ank2017@med.cornell.edu

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Study Results Of GAMMAGARD S/D And GAMMAGARD LIQUID In Patients With Mild To Moderate Alzheimer’s Disease Announced

New York-Presbyterian
Hospital/Weill Cornell Medical Center and Baxter International Inc. (NYSE:
BAX) announced results of a six-month, placebo-controlled Phase II study of
24 patients treated with GAMMAGARD S/D and GAMMAGARD LIQUID [Immune
Globulin Intravenous (IGIV)

The study met the primary endpoint criteria favoring
GAMMAGARD LIQUID and GAMMAGARD S/D over placebo on measures of cognitive
function and global impression of change

The study also met
secondary endpoints that measured changes in beta-amyloid and anti-amyloid
antibody levels in blood and cerebrospinal fluid

Results show findings
indicative of potential efficacy and tolerability

Beta-amyloid is a
substance thought to contribute to the degeneration of the brain in
Alzheimer’s disease. Clearing this substance from the central nervous
system, therefore is hypothesized to help remove or reduce the building
blocks of Alzheimer’s.

Baxter International Inc.

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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.

The 36-Hour Day: A Family Guide to Caring for People with Alzheimer Disease and Memory Loss in Later Life

 

Baxter claims its Gammagard immune booster protects against Alzheimer’s

Baxter International Inc.’s immune system boosting drug appeared to show some protective benefits against Alzheimer’s disease in a Baxter-funded analysis of medical claims data.

Baxter claims its Gammagard immune booster protects against Alzheimer’s

By Bruce Japsen

The Deerfield-based medical product giant is studying whether its drug, Gammagard, currently used as an intravenous immune system treatment, would slow or even stop the progression of Alzheimer’s. The medical claims analysis being used in part to justify future clinical studies, Baxter said.

The claims analysis indicated the risk of developing Alzheimer’s and related disorders may be reduced in patients previously treated with Gammagard, also known as intravenous immunoglobulin or IVIG. The study was co-authored by two executives from Plymouth Meeting, Pa.-based health data company, Surveillance Data Inc.

It analyzed medical claims data comparing 847 cases treated with Gammagard compared to 84,700 cases that were not treated. The proportion of patients diagnosed with dementia was 2 percent for treated cases compared to 4.2 percent for the untreated control group, the study showed.

The study would unlikely be used by Baxter as evidence to convince the U.S. Food and Drug Administration that Gammagard should be approved as a treatment for Alzheimer’s. Rather, researchers say the Surveillance Data study should be something used to “encourage additional research including adequate and well-controlled studies to confirm the benefits of IVIG in Alzheimer’s disease,” said Dr. Howard Fillit, professor of geriatrics, medicine and neurobiology at The Mount Sinai- NYU Medical Center in New York in a statement provided by Surveillance Data.

Controlled clinical studies are being worked on, Baxter said, but the company said the research is very early. A 24-patient study unveiled last summer by Baxter showed 16 patients on Baxter’s Gammagard had a better cognitive response than 8 patients on a placebo.

The idea behind the Baxter drug is that the body’s own immune system can potentially clear the brain of a protein fragment known as beta-amyloid that builds up and is thought to be a key in the development and progression of Alzheimer’s. Other companies, too, are studying immune system-based therapies, including a joint venture between New Jersey drug giant Wyeth and Dublin-based Elan Corp.

Alzheimer’s disease affects nearly 5 million Americans, and the number is rapidly rising. There are only some pills that slow the worsening of symptoms for about half the people who take them, experts say.

Hear Bruce Japsen on WBBM-AM 780 at 6:21 p.m. and 10:22 p.m. Mondays and 11:20 a.m. Saturdays.

bjapsen@tribune.com

 
 
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