PEGPH20: Phase II hold

Halozyme said that FDA placed a clinical hold on the recently halted open-label, U.S. Phase II Study 202 evaluating PEGPH20 in combination with Abraxane nab-paclitaxel and gemcitabine to treat untreated pancreatic cancer. Earlier this month, Halozyme halted enrollment and dosing in Study 202 on the recommendation of an IDMC, which is assessing a possible difference in the thromboembolic event rate between patients treated with PEGPH20 plus Abraxane and gemcitabine and patients treated with Abraxane and gemcitabine alone (see BioCentury, April 7). The company said FDA is also assessing the thromboembolic event rate. According to ClinicalTrials.gov, Study 202 is slated to enroll 132 patients. ...