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Halozyme's Phase 1b Clinical Trial Of PEGPH20 With Gemcitabine Indicates Positive Activity Against Pancreatic Cancer
Date:6/3/2013

SAN DIEGO, June 3, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced results from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. The full data will be presented today at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in a poster session from 1:15 PM-5:15 PM CDT and during a discussion session from 4:45 PM-5:45 PM CDT (E Hall D1, Abstract #4010).

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In this single-arm Phase 1b trial, the overall response rate (complete response + partial response) by RECIST 1.1 criteria was 42 percent (95% CI 22 - 62) for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg) as assessed by an independent radiology review (n=24). Additionally, in subjects with high levels of hyaluronan (HA), a substance found in a protective matrix that surrounds many pancreatic cancers, the overall response rate was 64 percent (7 of 11 subjects with available biopsy). Moreover, 43 percent (6 of 14 subjects) saw a reduction of at least 70 percent in serum carbohydrate antigen 19-9 (CA 19-9), a biomarker which often correlates with tumor cell burden.1  

"Targeting the protective tumor matrix with an enzyme that digests hyaluronan is a novel treatment strategy for solid tumors. In addition to enabling chemotherapy drugs to penetrate more effectively into the tumor, removing hyaluronan may also slow its growth," said lead investigator Sunil Hingorani , M.D., Ph.D., Associate Member of the Clinical Research and Public Health Divisions at Fred Hutchinson Ca
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SOURCE Halozyme Therapeutics, Inc.
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