SAN DIEGO, Dec. 10 Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology, and drug delivery markets, today announced the commencement of patient dosing for a Phase 1 clinical trial for a bisphosphonate administered with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20) as a subcutaneous (SC) injection. This study will explore the safety, tolerability and pharmacokinetics of SC administration of a bisphosphonate plus rHuPH20. Currently, injectable bisphosphonates must be administered intravenously (IV).
"We are pleased that the first clinical trial is underway for our bisphosphonate program, our third proprietary product development initiative to enter clinical studies," stated Jonathan Lim, M.D., President and CEO of Halozyme Therapeutics. "The bisphosphonate program joins insulin, for diabetes, and Chemophase, for superficial bladder cancer, our other two proprietary programs in clinical development. The goal of Halozyme's bisphosphonate program is to provide an alternative dosage formulation that may offer greater convenience, compliance and tolerability to patients for the treatment of osteoporosis."
This Phase 1 dose ranging clinical trial will assess the safety, tolerability and pharmacokinetics of a bisphosphonate with and without co-administration of rHuPH20 across a range of bisphosphonate concentrations and volumes and various rHuPH20 doses. The study will also compare SC administration of a bisphosphonate plus rHuPH20 to IV bisphosphonate alone.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase, for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential benefits of administering rHuPH20 with a bisphosphonate) 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-K, 10-Q, and other filings with the Securities and Exchange Commission.
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SOURCE Halozyme Therapeutics, Inc.