Halozyme Therapeutics Announces Data From Two Phase 1 Studies of PEGPH20 Demonstrating Targeting of Hyaluronan in Tumor Stroma

SAN DIEGO, Oct. 27, 2011 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced clinical trial results related to Halozyme's clinical stage drug, pegylated rHuPH20 (PEGPH20). The results were presented at the 2011 EORTC-NCI-ASCO Annual Meeting on "Molecular Markers in Cancer", taking place October 27-29 in Brussels, Belgium.

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Today's presentation focused on translational biomarker and pharmacodynamic results from the two Phase 1 dose-finding studies in patients with advanced solid tumors that were unresponsive to prior therapies. Study 101 investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of PEGPH20 as a single agent, and Study 102 investigated multiple-dosing of PEGPH20 in combination with dexamethasone.  

Results

The pharmacodynamics of PEGPH20 were first evaluated by measuring the concentration of circulating hyaluronan (HA) catabolites. HA plasma levels increased, in a dose-dependent manner, after PEGPH20 administration. Freeing up of HA by PEGPH20 is consistent with the expected mechanism of PEGPH20.

Tumor imaging from subsets of patients pre- and post-administration of PEGPH20 demonstrated that PEGPH20 treatment rapidly restored tumor perfusion and decreased metabolic activity in tumors. Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) showed that the imaging agent was able to access a pancreatic tumor more easily post-administration of PEGPH20. [¹⁸F]-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging showed a reduction in metabolic activity of lung metastases in a patient with metastatic rectal carcinoma after PEGPH20 treatment.

The expected mechanism of action of PEGPH20 was further confirmed by histochemical analysis of pre- and post-treatment tumor biopsies. Biopsies of liver metastases from two patients with colorectal carcinoma were stained for HA before and after one cycle of treatment with PEGPH20.  Reduced HA staining was observed in biopsies from both patients after treatment.

"We are pleased with the results from these translational studies which provide further support to the hypothesis that PEGPH20 can favorably alter the tumor stroma of HA rich tumors," said Joy Zhu, MD, PhD, Vice President of Oncology Clinical Development at Halozyme.  "The degradation of the protective halo of HA and normalized tumor perfusion are promising results that support our ongoing clinical trial studying PEGPH20 in combination with gemcitabine in patients with pancreatic cancer."

A copy of the poster may be obtained on the company website.

About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the insulin, cancer, dermatology and drug delivery markets. The company's product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze™ technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche, Baxter, ViroPharma and Intrexon to apply Enhanze™ technology to therapeutic biologics including Herceptin®, MabThera®, immunoglobulin, Cinryze® and recombinant human alpha 1-antitrypsin. Halozyme's Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme's pipeline target multiple areas of significant 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 timing, scope and outcomes of our clinical trials as well as expected activities under our collaborative partnerships) 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 clinical trial enrollment and results, 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.

Halozyme Contact
Kurt Gustafson
Chief Financial Officer
(858) 704-8272
[email protected]

SOURCE Halozyme Therapeutics, Inc.