Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subc...(ailability of the subcutaneouslyadminist...),Health

"These early results are the latest demonstration of Baxter's ongoing commitment to innovation and, in particular, to advancing the science of IGIV therapy," said Hartmut J. Ehrlich, MD, vice president of Global Research and Development for Baxter's BioScience business. "While further studies are required to confirm these results, Baxter plans to initiate a pivotal Phase III trial using GAMMAGARD LIQUID with Enhanze Technology pending discussions with regulatory authorities by the beginning of 2009."

Phase I/II Trial Design and Results

The Phase I/II clinical trial was the result of an agreement between Baxter and Halozyme Therapeutics, Inc., under which Halozyme's proprietary Enhanze Technology was applied to the development of a subcutaneous route of administration for GAMMAGARD LIQUID. Halozyme's Enhanze Technology is based on recombinant human hyaluronidase (rHuPH20), which facilitates dispersion and absorption of subcutaneously injected solutions. The Phase I/II trial evaluated the safety, tolerability and pharmacokinetics of a monthly subcutaneous administration of GAMMAGARD LIQUID with Enhanze Technology in 11 PID patients in the United States. The patients were infused with varying amounts of 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
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