Halozyme Therapeutics, a biopharmaceutical company dedicated to developing and commercialising innovative products that advance patient care, announced that the US Food and Drug Administration (US 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 chief executive officer, "We are pleased to be able to continue enrolling patients in this clinical programme as there remains a significant need for new treatment options for pancreatic cancer patients."
Study 202 (Halo 109-202) is a Phase 2 multicentre, randomised clinical trial evaluating PEGPH20 as a first-line therapy for treatment of patients with stage IV 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 has been added to assess the thromboembolic event rate in the PEGPH20 treatment arm following the protocol amendment. Secondary endpoints include objective response rate and overall survival. The protocol amendments to the study include the exclusion of patients who may be at higher risk of thromboembolic events. Additionally, low-molecular weight heparin will be used as a prophylaxis to prevent thromboembolic events. In addition to the over 100 patients already enrolled in the trial, Halozyme plans to enroll a similar number of additional patients.
PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumours that accumulate hyaluronan.