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Oct 6, 2010

Phase III Trial Shows Near Equivalence of Baxter’s Subcutaneous IG Therapy to IV Product

  • Baxter reported positive interim data from a Phase III clinical trial with its subcutaneous immune globulin (IG) therapy, HyQ, in patients with primary immune deficiency (PID). Results from the study showed that 28 of 29 HyQ-treated patients were able to infuse IG under the skin at infusion volumes, intervals, and rates that were equivalent to previous intravenous IG administration.

    A separate analysis of 23 patients in the study showed that an HyQ dose equivalent to 107% of intravenous IG was needed to achieve similar systemic levels of immune globin. Baxter claims this level of increase in dosage level is far lower than the 137% dose required to achieve equivalent IG levels when traditional subcutaneous administration is carried out.

    The interim data was presented at the 26th Meeting of the European Society for Immunodeficiences (ESID) in Istanbul, Turkey. The primary endpoint of the ongoing Phase III HyQ trial is the prevention of acute serious bacterial infections. Baxter says the benefit-risk profile of HyQ will be evaluated on study completion.

    HyQ is an IG therapy facilitated subcutaneously by recombinant human hyaluronidase. The IG is a solution prepared from large pools of human plasma. The treatment is being developed by Baxter using a recombinant human hyaluronidase technology licensed for Halozyme Therapeutics. The Phase III study is being carried out in 89 patients in 15 centers across the U.S. and Canada. Completion is projected by the end of 2010.

    Halozyme’s primary core technology is based on its recombinant human PH20 (rHuPH20) enzyme, a human synthetic version of hyaluronidase that degrades hyaluronan, and facilitates the penetration and diffusion of drugs and fluids administered subcutaneously.

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