Halozyme Therapeutics, a San Diego-based biopharmaceutical company, initiated a phase II multicenter, randomized clinical trial evaluating PEGPH20, a proprietary, investigational drug as a first-line therapy for patients with stage IV metastatic pancreatic cancer.
Approximately 124 patients will participate in the study and receive gemcitabine and nab-paclitaxel either with or without PEGPH20. The primary outcome will be to measure progression-free survival between patients administered PEGPH20 to those who are not.
"Pancreatic cancer is an extremely difficult disease to treat, in part because of a hyaluronan-rich matrix which shields these tumors against chemotherapy," said Daniel D. Von Hoff, M.D., F.A.C.P., lead principal investigator of the study and CSO for Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials and physician-in-chief for the Translational Genomics Research Institute (TGen). "Ongoing translational studies indicate that PEGPH20 may deplete this matrix component from pancreatic tumors and alter the tumor environment in a way that renders these cancers more vulnerable to therapy."
Gregory I. Frost, Ph.D., president and CEO of Halozyme, added, "We are hopeful that these studies with PEGPH20 will improve patient outcomes for this insidious disease while advancing our general understanding of the unique tumor environment.”
Halozyme recently completed enrollment of a single-arm phase Ib trial in a similar patient population treated with PEGPH20 and gemcitabine.