Baxter to Initiate Second Phase III Trial Studying GAMMAGARD LIQUID (IGIV) for the Treatment of Alzheimer's Disease
DEERFIELD, Ill., January 23, 2012 - Baxter International Inc. (NYSE:BAX) today provided an update on its clinical program evaluating the use of its GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG outside the United States and Canada), for the treatment of mild to moderate Alzheimer's disease. The company plans to initiate a second, confirmatory Phase III trial in the first quarter of 2012, having satisfactorily completed a futility analysis in its first Phase III trial.
"Today, patients affected by neurological conditions like Alzheimer's disease have limited treatment options. If successful, Baxter's Phase III trials will support a regulatory filing for use of immunoglobulin therapy in the treatment of Alzheimer's disease," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business.
The second Phase III trial is identical in design to the first Phase III trial, and will assess the safety and effectiveness of GAMMAGARD LIQUID as a potential treatment for signs and symptoms associated with Alzheimer's disease. It is a global, multi-center clinical trial that will enroll approximately 400 patients and is expected to take an estimated three years to complete. Approximately 80 centers in North America, Europe, Japan and Australia will participate in the study. The primary endpoint of the study is to evaluate the effectiveness of GAMMAGARD LIQUID 10% on preserving cognitive performance and functional activities in patients with mild to moderate Alzheimer's disease, as compared to standard of care, over an 18-month period.
This second, confirmatory trial follows a separate, ongoing Phase III Gammaglobulin Alzheimer's Partnership (GAP) trial sponsored by Baxter in collaboration with the Alzheimer's Disease Cooperative Study (ADCS), a clinical trial consortium supported by the National Institutes of Health. Enrollment in the first Phase III trial was completed in June 2011 and the study's Data Safety Monitoring Board (DSMB) recently completed a futility analysis - an early analysis to determine if the trial should continue. A futility analysis is not intended to demonstrate achievement of efficacy endpoints.
"After reviewing the futility analysis, the DSMB stated the ongoing GAP study could continue without modification. We look forward to seeing the final data in 2013 regarding the trial's endpoints, specifically whether GAMMAGARD LIQUID 10% will be a viable option for the treatment of this disease," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business.
For specific trial details and to learn more about enrollment criteria, patients and caregivers may go to www.clinicaltrials.gov.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is currently indicated as a replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD LIQUID was originally approved by the U.S. Food and Drug Administration (FDA) in September 2005. Also known as KIOVIG outside the United States and Canada, it is approved in 51 countries worldwide.
IMPORTANT RISK INFORMATION
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
- Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
- For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.
Prior to administering GAMMAGARD LIQUID, ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients over 65 years of age or judged to be at risk for renal dysfunction or thrombotic events, GAMMAGARD LIQUID must be administered at the minimum infusion rate practicable. In such cases, the maximal rate should be less than 3.3 mg/kg/min (< 2mL/kg/hr), and consider discontinuation of administration if renal function deteriorates.
GAMMAGARD LIQUID is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.
GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
Anaphylaxis has been reported with the intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous administration.
Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immune globulin.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.
Thrombotic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism have been reported in association with intravenous use of GAMMAGARD LIQUID. Thrombotic events have also been reported with subcutaneous administration of immune globulin. Patients at risk for thrombotic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.
Aseptic Meningitis Syndrome may occur with IGIV treatment, and has been reported with intravenous use of GAMMAGARD LIQUID. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
GAMMAGARD LIQUID contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immune globulin. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop due to enhanced RBC sequestration.
Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the classic Creutzfeldt-Jakob disease agent. This also applies to unknown or emerging viruses and other pathogens.
No cases of transmission of viral diseases or vCJD have been associated with GAMMAGARD LIQUID.
Intravenous: The most serious adverse reaction seen during intravenous treatment in the clinical trials was two episodes of aseptic meningitis in one subject. The most common adverse reactions (observed in ?5% of subjects) were headache, pyrexia, fatigue, rigors, nausea, chills, dizziness, vomiting, migraine headache, pain in extremity, urticaria, cough, pruritus, rash, and tachycardia.
Please review the GAMMAGARD LIQUID Prescribing Information for full prescribing details.
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, 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.
This release includes forward-looking statements concerning the potential use of GAMMAGARD LIQUID intravenous immunoglobulin (IVIG) for the treatment of mild to moderate Alzheimer's disease, including expectations with respect to the related Phase III trials. 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: satisfaction of regulatory and other requirements; clinical results demonstrating the safety and effectiveness of IVIG as a potential treatment for Alzheimer's disease; the ability of the company to enroll a sufficient number of qualified participants in the second Phase III trial; actions of regulatory bodies and other governmental authorities; timely submission and approval of regulatory filings; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.