Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subc...( Phase I/II data showed that Enhanze...),Health

Phase I/II data showed that Enhanze Technology(TM) enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with

Primary Immunodeficiency

PHILADELPHIA, March 16 /PRNewswire-FirstCall/ -- Baxter International Inc. (NYSE: BAX) today announced the preliminary results of a Phase I/II clinical trial, in which subcutaneous infusion (under the skin) of GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] (IGIV) with Enhanze(TM) Technology enabled administration of a full monthly dose via a single site to patients with primary immunodeficiency (PID). The results were presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in Philadelphia, PA.

GAMMAGARD LIQUID is approved for intravenous administration, which due to large infusion volumes of the therapy needing to be delivered, can take several hours once a month at a doctor's office or hospital. By contrast, subcutaneous administration of IGIV has been limited by the inability of the tissue to absorb large volumes of injected drugs, creating the need to administer the therapy in smaller, weekly doses and through multiple injection sites. Subcutaneous administration of GAMMAGARD LIQUID with Enhanze Technology via a single site could allow patients to administer a sufficient dose of IGIV once monthly at home.

In the Phase I/II trial, 10 of the 11 patients studied received monthly doses of subcutaneously administered GAMMAGARD LIQUID with Enhanze Technology of 25.5 to 61.2 grams (255 to 612 mL) in a single site. All patients in the trial received the therapy at infusion rates between 120 mL/hr to 300 mL/hr, similar to infusion rates for intravenous administration. The average bioav
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