Halozyme Therapeutics, has announced that the FDA has removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol. 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. In May, the trial's independent Data Monitoring Committee (DMC) recommended that enrollment and dosing in the study resume under a revised protocol.
"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," commented Dr. Helen Torley, President and CEO. "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."