Baxter Begins Pivotal U.S., European Clinical Trials for New, Liquid Immune Gl

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Monday July 15, 9:01 am Eastern Time
Press Release
SOURCE: Baxter Healthcare Corporation

Baxter Begins Pivotal U.S., European Clinical Trials for New, Liquid Immune Globulin Product


DEERFIELD, Ill., July 15 /CNW/ -- Baxter Healthcare Corporation announced today that it has begun pivotal clinical trials in the United States and Europe for a new liquid immune globulin therapy, Immune Globulin Intravenous (Human), 10% Solution (IGIV 10%).
The U.S. clinical study is a phase III, multi-center, randomized trial evaluating safety and efficacy in patients with primary immunodeficiency. The European study is a multi-center, open-label evaluation of pharmacokinetics, efficacy and safety in patients with primary immunodeficiency. Primary immunodeficiency is a group of genetic disorders in which the body is unable to produce adequate amounts of antibodies, thereby predisposing individuals to increased risk of infection. An additional study is being conducted in Europe of patients with another immune disorder, chronic idiopathic thrombocytopenic purpura, in which the body destroys its own platelets.

Baxter's new liquid immune globulin therapy is made from human plasma. Obtained from pre-screened U.S. donors, the plasma is tested for viral genome sequences of Human Immunodeficiency Viruses Types 1 and 2, Hepatitis B and Hepatitis C Viruses. During processing, Baxter's new IGIV 10% undergoes three dedicated virus inactivation and removal steps, including: the company's proprietary solvent detergent treatment, nanofiltration and low pH treatment. The solvent detergent process inactivates lipid enveloped viruses, while nanofiltration and low pH treatment inactivate and remove both enveloped and non-enveloped viruses.

"This new liquid IGIV builds upon the excellent clinical experience our current Gammagard S/D product has demonstrated, in a formulation that promises greater convenience in administration," said Sharon Tonetta, Ph.D., vice president of clinical affairs for Baxter's BioScience business.

Baxter Healthcare Corporation is the principal domestic operating business of Baxter International Inc. (NYSE: BAX - News). Baxter International Inc. is a global health care company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. Baxter's bioscience, medication delivery and renal products and services are used to treat patients with some of the most challenging medical conditions including cancer, hemophilia, immune deficiencies, infectious diseases, kidney disease and trauma.

(Baxter and Gammagard are trademarks of Baxter International Inc. and its affiliates.)


For further information

Media, Deborah Spak, +1-847-948-2349, or Investor, Neville Jeharajah, +1-847-948-2875, or Mary Kay Ladone, +1-847-948-3371, all of Baxter Healthcare Corporation