Halozyme To Continue PEGPH20 Trial After FDA Lifts Clinical Hold

Halozyme Therapeutics announced that it is resuming its ongoing Phase II trial of PEGPH20 in patients with pancreatic cancer following the U.S. Food and Drug Administration’s (FDA) removal of its clinical hold on patient enrollment and dosing in the study.

Study 202 will resume accepting patients upon approval of a revised protocol by the Independent Review Boards.

The FDA placed patient enrollment and dosing on clinical hold last April after the company decided to halt the trial. The decision was based on a recommendation from the Data Monitoring Committee (DMC), which assessed data suggesting a difference in the thromboembolic events between the two groups in the study. One group was treated with PEGPH20, nab-paclitaxel and gemcitabine while the other group of patients was treated with nab-paclitaxel and gemcitabine without PEGPH20. In May, the DMC recommended that the trial be continued under a modified protocol.

Dr. Helen Torley, president and CEO of Halozyme, said, “We are committed to the development of PEGPH20 in pancreatic cancer. Halozyme worked diligently with the FDA and the DMC to develop the plan to allow the study to restart. We are pleased to be able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients.”

PEGPH20 is an investigational PEGylated form of the company's proprietary recombinant human hyaluronidase, currently being developed for the systemic treatment of tumors that accumulate hyaluronan.

The trial is investigating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. The primary outcome of the trial is to determine whether patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel versus gemcitabine and nab-paclitaxel alone improve progression-free survival (PFS). The secondary primary endpoint is the assessment of thromboembolic event rate in the PEGPH20 treatment arm following the protocol amendment. Secondary endpoints of the trial also include objective response rate and overall survival (OS).

The company saw an improvement in shares following the lift: shares rose by 11 percent one day after the FDA announced its removal of the clinical hold on Halozyme’s trial.