PEGPH20: Phase II amended

Halozyme said FDA lifted a clinical hold on the open-label Phase II Study 202 comparing PEGPH20 in combination with Abraxane nab-paclitaxel and gemcitabine vs. Abraxane and gemcitabine. The trial will resume under an amended protocol, pending IRB approval, which will exclude patients at higher risk of thromboembolic events, and low-molecular weight heparin will be used to prevent thromboembolic events. The amended protocol also includes a second primary endpoint assessing the thromboembolic event rate in the PEGPH20 arm. Halozyme plans to enroll >100 patients in addition to the >100 patients already enrolled. In April, FDA placed the trial on clinical hold following a possible difference in the thromboembolic event rate observed by the IDMC between the 2 arms (see BioCentury, April 7 & April 14). ...