Halozyme Therapeutics has paused a phase II trial of its investigational pancreatic cancer drug in order to assess the candidate’s safety.
The California-based biopharma said it was ‘temporarily halting’ patient enrolment and dosing of its compound PEGPH20 in Study 202 while it investigated the risk of blood clot associated with the drug.
The decision is based on a recommendation from an independent data monitoring committee, which now plans to assess clinical data from the study which suggests that the rate of thromboembolic events in the PEGPH20 arm of the trial is higher than that of the non-PEGPH20 arm.
Halozyme said that halting patient enrolment and dosing were ‘precautionary actions while the data monitoring committee’s full evaluation of the data is ongoing’.
The risk of blood clotting has been a problem associated with other cancer drugs, including most recently Ariad’s leukaemia drug Iclusig, which faced safety investigations in both the US and EU, as well as a halted trial, after some patients developed blood clots.
In the US the FDA initially suspended sales of Iclusig, but later allowed marketing of the drug to be resumed following a revised indication statement and boxed warning. The European Medicines Agency also allowed the continued sale of Iclusig, although with added safety recommendations.
As for the fate of PEGPH20, Halozyme’s CEO Dr Helen Torley said: “Patient safety is our first priority.”
She added: “We will be providing additional information to the data monitoring committee as quickly as possible so they can complete their assessment and we can determine next steps.”