SAN DIEGO, Nov. 27 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (AMEX:HTI), a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced it has completed the enrollment of a clinical trial of Enhanze(R) Technology, Halozyme's enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase (rHuPH20), intended in this trial to enhance the absorption of a representative commercially-available large protein molecule therapeutic.
This clinical trial was designed to compare the pharmacokinetics (PK), safety and tolerability of a large protein molecule therapeutic agent subcutaneously injected both with and without rHuPH20. The dose escalation, within-patient controlled study used escalating doses of rHuPH20 and substituted a standard SC injection of the therapeutic agent with a SC injection of the therapeutic agent combined with rHuPH20. The study compared the bioavailability and other PK parameters, along with safety and tolerability, of the two SC injections, one with and one without rHuPH20.
As a spreading agent, hyaluronidase has traditionally been used to accelerate the delivery of drugs and fluids, including local anesthetics, other co-injected drugs, and contrast agents, and for subcutaneous (SC) fluid replacement. Although a large body of clinical experience supports the benefits and safety of using hyaluronidase as an adjuvant to increase the absorption and dispersion of co-injected small molecule drugs, clinical studies have not previously been performed to support the benefits and safety of recombinant human hyaluronidase use with large molecule agents, such as monoclonal antibodies and other large molecule biologics. If findings from this current clinical trial are supportive, the clinical application of rHuPH20 may be further explored and potentially expanded to address unmet needs in the administration of large molecule agents, opening up new areas of therapeutic indications.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products 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 extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase(R), the first and only recombinant human hyaluronidase for cumulus removal in the IVF process, and Hylenex, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop products as a medical device, drug enhancement agent, and therapeutic drug.
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, regulatory strategy, regulatory filing dates and clinical trials) 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-Q, and other filings with the Securities and Exchange Commission.
Halozyme Contact Investor Relations Contact
David A. Ramsay Zachary Bryant
Chief Financial Officer Lippert/Heilshorn & Associates
(858) 794-8889 (310) 691-7100
Media Contacts
Megan Swanland Riggs / Joleen Schultz
Mentus
(858) 455-5500, x230/x215
DATASOURCE: Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of Halozyme, +1-858-794-8889, ; or Investor Relations, Zachary Bryant of Lippert/Heilshorn & Associates, +1-310-691-7100, , for Halozyme Therapeutics, Inc.; or Media, Megan Swanland Riggs, ext. 230, , or Joleen Schultz, ext. 215, , both of Mentus, +1-858-455-5500, for Halozyme Therapeutics, Inc.
Web site: http://www.halozyme.com/
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