Halozyme starts trial for subcutaneous hydration with Hylenex

By E. Janene Geiss

Philadelphia, Dec. 15 - Halozyme Therapeutics, Inc. announced Thursday that it has initiated and dosed the first cohorts of volunteer subjects in a clinical trial of subcutaneous hydration (hypodermoclysis) with Hylenex.

Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20), according to a company news release.

Subcutaneous hydration is the introduction of fluids under the skin, eliminating the need for inserting a catheter into the vein, to replace inadequate intake or excessive loss of water and electrolytes during illness or operation.

Hylenex is a recombinant human hyaluronidase approved for use as a spreading agent to accelerate the delivery of fluids and drugs, such as local anesthetics and other co-injected drugs, contrast agents and for subcutaneous fluid replacement, officials said.

Halozyme received approval from the Food and Drug Administration for Hylenex on Dec. 2.

The study is designed to determine the subcutaneous infusion flow rate of a lactated ringer's solution with and without Hylenex, assess the subcutaneous infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability, officials said.

Lactated ringer's solution is a widely used fluid for intravenous rehydration. The double-blind, randomized, placebo-controlled, dose-comparison study will enroll up to 70 subjects, officials said.

"Establishing a favorable risk-benefit ratio could lead to the widespread adoption of rapid [subcutaneous] hydration as the parenteral infusion route of choice for clinically dehydrated patients in many clinical scenarios," Jay Thomas, clinical medical director of San Diego Hospice & Palliative Care, said in the release.

"Because [subcutaneous] hydration requires less skill to implement and can be delivered in a wider variety of patient care settings, it may also have a favorable impact on the cost of health care," Thomas said. "For example, rather than transferring a dehydrated patient to an emergency room, a hospital or a skilled nursing facility, [subcutaneous] hydration could be given in the home or in a doctor's office."

Halozyme is a San Diego biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for infertility, ophthalmology and oncology.

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