Halozyme Therapeutics has announced that as a result of a recommendation received yesterday from an independent Data Monitoring Committee (DMC), it is 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 is assessing clinical data that indicates 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 is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing.
"Patient safety is our first priority," stated Dr. Helen Torley, President and CEO. "We will be providing additional information to the DMC as quickly as possible so they can complete their assessment and we can determine next steps."