Halozyme Therapeutics Says FDA Places Clinical Hold On Pancreatic Cancer Trial

(RTTNews) - Halozyme Therapeutics Inc. (HALO) announced that the United States Food and Drug Administration or FDA informed the company that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.

According to the FDA, this action was being taken in view of the company's recent decision to temporarily halt enrollment and dosing of PEGPH20 in the Phase 2 trial.

Last week, Halozyme Therapeutics announced that, as a result of a recommendation received from an independent Data Monitoring Committee or DMC, it was temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.

The DMC was assessing clinical data that indicated a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20.

The company said it was halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data was ongoing.