22 July 2014 - 22 July 2014 - US Halozyme Therapeutics Inc (NASDAQ:HALO) said Tuesday it had resumed patient accrual and treatment in an ongoing Phase II study of PEGPH20 as a therapy of pancreatic cancer, under an amended clinical protocol agreed to with the US FDA last month.

As previously reported, the agency lifted the clinical hold on patient recruitment and dosing in the trial, allowing it to continue under the revised protocol, in early June.

The multi-centre, randomised trial, dubbed Study 202, is assessing PEGPH20 as a first-line therapy of patients with stage IV metastatic pancreatic cancer. The primary goal is to evaluate increase in progression-free survival in patients taking PEGPH20 plus gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone. A second primary objective will evaluate the thromboembolic event rate in the PEGPH20 treatment group. Secondary goals are objective response rate and overall survival.

PEGPH20 is an investigational PEGylated form of the company's recombinant human hyaluronidase being developed for the systemic treatment of tumours accumulating hyaluronan.