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Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
Date:1/8/2008

ere attained without difficulty. Electrolyte replacement in hydration fluid was achieved without incident in several patients. In addition to use for fluid hydration, six patients received HYLENEX to enhance Sub-Q infusion of nine different medications (hydromorphine, lidocaine, dexamethasone, haloperidol, midazolam, ondansetron, famotidine, sufentanil, and glycopyrrolate), primarily because the medication dosage required Sub-Q flow rates greater than the standard 3 mL/hour. There were no significant adverse events (AEs); induration at the infusion site occurred in one patient receiving hydration and higher than expected serum lidocaine concentration was observed in another patient.

As previously reported (see February 8, 2006 Halozyme press release), the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer's clinical trial, or INFUSE-LR study, was designed to determine the Sub-Q infusion flow rate of Lactated Ringer's (LR) solution with and without HYLENEX, determine the Sub-Q infusion flow rate dose response to HYLENEX over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24-gauge catheters. The key findings from this study are:

In every subject tested in this study, HYLENEX injection preceding the

gravity-driven LR infusions enabled flow rates approximately 250% to 400%

faster than the infusions without HYLENEX. The overall mean flow rate for

Sub-Q infusion with HYLENEX was 464 mL/hr versus 118 mL/hr with placebo

(p<0.0001).

Despite the faster rate of LR infusion into the HYLENEX-assisted arms, the

HYLENEX arms demonstrated significantly less edema in all HYLENEX dose

groups and all timepoints during infusions. Across the three HYLENEX dose

cohorts, 94% of subjects had moderate
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SOURCE Halozyme Therapeutics, Inc.
Copyright©2008 PR Newswire.
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