Halozyme Announces Resumption of Patient Enrollment, Dosing in PEGPH20 Clinical Trial

Halozyme Therapeutics, Inc.

today announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed to with the FDA in June. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan. "Our diligent effort to rapidly re-initiate patient enrollment and dosing of both previously enrolled and new patients in this trial underscores our commitment to evaluating the potential role of PEGPH20 in patients with stage 4 metastatic pancreatic cancer. Approximately 50% of the anticipated clinical sites have received IRB approvals, and we anticipate continued IRB approvals in the coming weeks," commented Dr. Helen Torley, President and Chief Executive Officer. Study 202 Trial Design Study 202 (Halo 109-202) is a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for treatment of patients with stage 4 metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint will assess the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.