Halozyme Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to PEGPH20 (PEGylated recombinant human hyaluronidase) for the treatment of pancreatic cancer. PEGPH20 is an investigational PEGylated form of recombinant human hyaluronidase.
In September 2014, the FDA had removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG’s ongoing Phase 1b/2 clinical trial. The trial is designed to evaluate PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol, and 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.
Halozyme is currently investigating PEGPH20 in a Phase 2 study in combination with gemcitabine and Abraxane (nab-paclitaxel) in metastatic pancreatic cancer.
For more information visit Halozyme.com.