Baxter reports preliminary results of Phase I/II immunodeficiency trial

The Phase I/II trial evaluated the safety, tolerability and pharmacokinetics of a monthly subcutaneous administration of Gammagard Liquid with Enhanze Technology in 11 primary immunodeficiency (PID) patients in the US. The patients were infused with varying amounts of recombinant human hyaluronidase (rHuPH20) with one-, two-, three- and then four-week doses of Gammagard Liquid to determine the amount of enzyme required to enable a full monthly dose to be infused in a single site at rates equivalent to those administered in intravenous infusions. The trial also evaluated the effect of rHuPH20 on the bioavailability of Gammagard Liquid administered subcutaneously compared to intravenously.

One patient withdrew from the study, citing moderate discomfort with the one-week dose, while the 10 patients who completed the study experienced mild local reactions that were not dose-limiting, such as swelling and redness. No drug-related allergic reactions occurred. Administration time and flow rates were limited by pump characteristics and not by patient discomfort.

In addition to the announcement of results for the Phase I/II for Gammagard Liquid and Enhanze Technology, Baxter also announced the initiation of a pivotal Phase III trial of subcutaneous administration of Gammagard Liquid alone. The Phase III trial will evaluate the bioavailability of Gammagard Liquid after administration intravenously, subcutaneously or subcutaneously at an adapted dose, as measured by the area under the curve of IgG concentration versus time curve per week. Final results of the study are expected to become available in 2009.