SAN DIEGO, Jan. 24 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has completed enrollment of a clinical trial of subcutaneous (SC) hydration (hypodermoclysis) with Hylenex. 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. 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, is designed to determine the subcutaneous infusion flow rate of 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. Lactated Ringer’s solution is a widely used fluid for intravenous rehydration. 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, TN, February 8-11, 2006.
About Hylenex
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex recombinant is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. The contraindications and warnings regarding the use of Hylenex should be recognized and adhered to prior to prescription or administration. For full prescribing information, visit www.hylenex.com or www.halozyme.com.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company’s portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme’s recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company’s products under development, product development plans, clinical trials and results) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company’s reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.
Halozyme Contact David A. Ramsay Chief Financial Officer (858) 794-8889 dramsay@halozyme.com Investor Relations Contacts Don Markley / Zachary Bryant Lippert/Heilshorn & Associates (310) 691-7100 dmarkley@lhai.com Media Contacts Kathy Sweeney / Joleen Schultz Mentus (858) 455-5500, x230/x215 kwitz@mentus.comjschultz@mentus.com
Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of HalozymeTherapeutics, Inc., +1-858-794-8889, dramsay@halozyme.com; or investors,Don Markley, dmarkley@lhai.com, or Zachary Bryant, both ofLippert/Heilshorn & Associates, +1-310-691-7100, for Halozyme Therapeutics,Inc.; or media, Kathy Sweeney, +1-858-455-5500, ext. 230, kwitz@mentus.com,or Joleen Schultz, +1-858-455-5500, ext. 215, jschultz@mentus.com, both ofMentus, for Halozyme Therapeutics, Inc.
