Halozyme resumes enrolment and dosing of patients under revised protocol with US FDA

22 July 2014
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US-based pharmaceutical company Halozyme Therapeutics (Nasdaq: HALO) has said it is once again enrolling and dosing patients in its ongoing Phase II trial to evaluate PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed with the US Food and Drug Administraion last month.

Trials of PEGPH20 were halted in April 2014 owing to FDA concerns over a possible difference in thromboembolic event rate between patients treated with the drug to those treated without it in the trial.

The treatment being tested is an investigational PEGylated form of Halozyme’s propriety recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.

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