Baxter Healthcare Corporation 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, vice president of clinical affairs for Baxter's BioScience business.