OncoMed halts patient enrollment and dosing in two trials

Shares of OncoMed (OMED -19%) are down on higher volume in response to the company's announcement that it has voluntarily halted patient enrollment and dosing in two clinical trails due to higher-than-expected adverse events.

In a Phase 1a study of vantictumab, 8 of 63 (13%) patients have experienced bone-related adverse events. In a Phase 1a study of Fzd8-Fc, 2 of 41 (5%) have experienced the same adverse events.

After analyzing the data with expert advisors, the company will submit amended protocols to the FDA and subsequently to the trial sites. The amendments will modify the dosing regimens, update risk mitigation measures and enrollment criteria. In parallel, the company will continue existing or modified dosing for those patients in both studies with no disease progression who have not experienced significant drug-related adverse events.

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