Halozyme completes enrollment for Hylenex subcutaneous hydration trial

By Angela McDaniels

Seattle, Jan. 24 - Halozyme Therapeutics Inc. said it has completed enrollment for a clinical trial of subcutaneous hydration with Hylenex.

Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient recombinant human hyaluronidase (rHuPH20), which the company said is approved by the Food and Drug Administration for use as a spreading agent to increase the absorption and dispersion of other injected drugs.

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 clinical trial is designed to determine the subcutaneous infusion flow rate of lactated Ringers solution with and without Hylenex, assess the subcutaneous infusion flow rate dose response to Hylenex and assess safety and tolerability. Lactated Ringers solution is a widely used fluid for intravenous rehydration, according to a company news release.

The double-blind, randomized, placebo-controlled, dose-comparison study reached its target enrollment of 50 evaluable subjects. Results are expected to be presented at the 2006 American Academy of Hospice and Palliative Medicine's Annual Assembly in Nashville, Tenn., during the week of Feb. 8.

Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for subcutaneous hydration and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Halozyme is a biopharmaceutical company based in San Diego that develops and commercializes recombinant human enzymes for infertility, ophthalmology and oncology.

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