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Halozyme Presents PEGPH20 Phase 1b Clinical Trial Data at European Cancer Congress 2013
Date:9/30/2013

that tumor-cell associated HA may be a better predictor of PEGPH20 combination treatment effect compared to stromal associated HA.

Treatment was generally well tolerated, and the adverse event profile was consistent with those seen in previous studies of PEGPH20 as a single agent and as previously reported for gemcitabine alone. The most common adverse events for PEGPH20 were muscle spasms, myalgia and arthralgia (all grade 1/2). There was no evidence of new toxicities when used in combination with gemcitabine and the pharmacokinetics of PEGPH20 with gemcitabine was consistent with the pharmacokinetics of PEGPH20 as a single agent. Additionally, the pharmacodynamic and pharmacokinetics results support the dosing regimen of PEGPH20 at 3µg/kg, which is being used in an on-going Phase 2 trial.

Halozyme has initiated a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 in combination with nab-paclitaxel and gemcitabine to confirm the combination treatment effect (ORR, PFS and OS) based on HA levels. The study plans to enroll approximately 124 patients with stage IV pancreatic ductal adenocarcinoma. Halozyme is also developing an HA diagnostic tool to be used in this study to evaluate the potential treatment benefit based on tumor HA levels at baseline. This diagnostic approach may enable additional PEGPH20 combination clinical studies in other HA-rich tumor types.

About PEGPH20

Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is itself an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor and rapidly changes the tumor microenvironment and metabolism, which may render the tumor more vulnerable to therapy as well as inhibit tumor growth.

About Pancreatic Cancer

In most patients diagnosed with metastatic pancreatic adenocarcinoma, survival rates are the low
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SOURCE Halozyme Therapeutics, Inc.
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