Home | Business News | Browse by Publication | P | PR Newswire

Halozyme Therapeutics and Baxter Release Results From the INFUSE-LR Study.

Article Excerpt
- Use of Hylenex Accelerates Subcutaneous Flow Rates With Acceptable Tolerability -

SAN DIEGO, and DEERFIELD, Ill., Feb. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. and Baxter Healthcare Corporation today announced the results of INFUSE-LR, a clinical trial of subcutaneous (Sub-Q) infusion (hypodermoclysis) with Hylenex. The use of Hylenex preceding Sub-Q infusion accelerated the flow rate by approximately four-fold versus the Sub-Q infusion with placebo, while causing less edema and was preferred by both investigator (for 92% of subjects) and study subjects (92%).

Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20), which is approved by the U.S. Food and Drug Administration (FDA) for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for Sub-Q hydration. Subcutaneous hydration is the introduction of fluids under the skin to replace inadequate intake or excessive loss of water and electrolytes during illness or operation.

The INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer's clinical trial, or INFUSE-LR study, was designed to determine the subcutaneous 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, within-subject,...