Phase 2 Clinical Trial to Assess Safety, Tolerability and Efficacy of Gemcitabine Combined with PEGPH20
SAN DIEGO, Oct. 5, 2011 /PRNewswire via COMTEX/ --
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 globally. The primary endpoint of the Phase 2 portion of the trial is overall survival (OS). The trial will also evaluate secondary endpoints such as CA19-9, objective response rate and duration of response. CA19-9 is a tumor marker tested from blood samples in patients with pancreatic cancer.
PEGPH20 is a PEGylated form of rHuPH20 modified to allow it to survive in the blood stream. PEGPH20 degrades hyaluronan (HA) which is a gel-like component found in tissues throughout the body. Certain solid tumor types (e.g. colon, breast, pancreatic and prostate cancers) have been shown to accumulate high levels of HA which creates a protective network surrounding the tumor cell. By degrading the HA, PEGPH20 may increase the accessibility of tumor cells to chemotherapeutic agents and improve the effectiveness of the treatment.
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. The National Cancer Institute estimates that in 2011 there will be more than 44,030 new cases of pancreatic cancer and 37,660 deaths from the disease.
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(TM) 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 http://www.halozyme.com/.
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