FDA lifts clinical hold on Halozyme's PEGPH20

Halozyme Therapeutics Inc. (NASDAQ:HALO) said FDA lifted a clinical hold on its Phase II Study 202 of PEGPH20 in combination with Abraxane nab-paclitaxel and gemcitabine for first-line treatment of pancreatic cancer. In April, FDA placed the trial on clinical hold following a possible difference in the thromboembolic event rate observed by the IDMC between patients treated with PEGPH20 plus Abraxane and gemcitabine and those treated with Abraxane and gemcitabine alone.

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 over 100 patients in addition to the more than 100 patients already enrolled. ...