SAN DIEGO, Oct. 5, 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 the commencement of patient dosing in a Phase 2 clinical trial with pegylated rHuPH20 (PEGPH20) in patients with stage IV previously untreated pancreatic cancer. This multi-center, international, randomized, placebo-controlled trial will study the safety, tolerability and efficacy of gemcitabine plus PEGPH20 compared to gemcitabine plus placebo.
"Pancreas cancer continues to be an extremely challenging disease for both patients and physicians alike and, unfortunately, most patients with pancreas cancer live less than one year from the time of diagnosis," said Sunil R. Hingorani, M.D., Ph.D. of the Fred Hutchinson Cancer Research Center, a pancreas cancer biologist and principal investigator for the trial. "However, a number of recent observations from both preclinical and early Phase 1 clinical studies suggest that PEGPH20 may render pancreas cancers more susceptible to conventional chemotherapy by depleting the tumor stroma of hyaluronan, improving vascular perfusion and preferentially increasing drug delivery to the tumor bed."
The trial, which includes a single arm run-in stage, will evaluate gemcitabine plus PEGPH20 compared to gemcitabine plus placebo in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. In the Phase 2 portion, patients will be randomized to receive either PEGPH20 plus gemcitabine or placebo plus gemcitabine, respectively. Over 140 patients are expected to be enrolled gl
|SOURCE Halozyme Therapeutics, Inc.|
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