Halozyme Announces SWOG Will Resume Clinical Trial of PEGPH20 In Combo with Modified FOLFIRINOX for Advanced Pancreatic Cancer

Halozyme Therapeutics, Inc.

today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1b/2 clinical trial (S1313). The trial is designed to evaluate Halozyme's investigational drug PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol, and patient enrollment is anticipated to recommence upon review and approval of the amended protocol by the Independent Review Boards at the participating clinical trial sites. The trial, which will enroll approximately 170 patients, is being sponsored by SWOG, a cancer research cooperative group of approximately 5,000 researchers in more than 650 institutions nationwide. "Study S1313, along with our 202 Study, will provide important data for evaluating the potential role of PEGPH20 in patients with stage 4 metastatic pancreatic cancer," commented Dr. Helen Torley, President and CEO. "We are pleased that SWOG is able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients." Additional Information On Study S1313 The Phase 1b run in portion of the S1313 study will be a limited dose de-escalation clinical trial examining the dose-limiting toxicities (DLT) in 6 to 18 patients, to identify the optimal dose for PEGPH20 used in combination with mFOLFIRINOX in patients with newly diagnosed metastatic pancreatic adenocarcinoma in the Phase 2 portion of the study. The Phase 2 portion will be a randomized, multicenter, parallel arm study enrolling approximately 152 patients to yield 138 evaluable patients. The primary end point of the trial is overall survival (OS) and secondary endpoints include progression-free survival (PFS), overall response rate (ORR), and toxicity. In addition, the study will also explore the treatment impact on carbohydrate antigen 19-9 (CA 19-9), a biomarker often associated with tumor cell burden1, as well as the correlation of plasma hyaluronan (HA) and tumor HA with OS, PFS and ORR. Additionally, low-molecular weight heparin and aspirin may be used to manage thromboembolic events. The mFOLFIRINOX treatment regimen consists of oxaliplatin, leucovorin, irinotecan and 5-fluorouracil. Additional study details can be found at http://www.clinicaltrials.gov using the study identifier NCT01959139.