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BAXTER
BEGINS PIVOTAL U.S., EUROPEAN CLINICAL TRIALS FOR NEW, LIQUID IMMUNE GLOBULIN
PRODUCT
DEERFIELD, ILL., July
15, 2002 -- 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). 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 ADDITIONAL
INFORMATION:
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- Media Contact:
- Deborah Spak, 847-948-2349
- Investor Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
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