Halozyme Resumes Patient Enrollment And Dosing In PEGPH20 Clinical Trial With KEYTRUDA

On July 25, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it has resumed the enrollment and dosing of patients in its ongoing Phase 1b trial evaluating its investigational new drug, PEGPH20, in combination with KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung and gastric cancers under a revised clinical protocol (Press release, Halozyme, JUL 25, 2016, View Source [SID:1234514020]).

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The revised protocol has been submitted to all institutional review boards (IRB) and is pending feedback from the FDA. The majority of IRBs have completed their review and approved the revised protocol allowing the study to resume.

The Phase 1b study will enroll up to approximately 80 patients at a number of leading sites in the United States. For more information, go to www.clinicaltrials.gov and reference NCT02563548.

For information on KEYTRUDA, please go to www.keytruda.com.

About PEGPH20

PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.