BioCentury
ARTICLE | Clinical News

PEGPH20: Phase II resumed

August 11, 2014 7:00 AM UTC

Halozyme resumed the open-label Phase II Study 202 comparing PEGPH20 in combination with Abraxane nab-paclitaxel and gemcitabine vs. Abraxane and gemcitabine under an amended protocol approved by FDA in June. FDA placed the trial on clinical hold in April following a possible difference in the thromboembolic event rate observed by the IDMC between the 2 arms (see BioCentury, April 7; April 14 & June 9).

The amended protocol excludes patients at higher risk of thromboembolic events and added the use of low-molecular weight heparin 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 the trial. ...