BioCentury
ARTICLE | Clinical News

FDA lifts partial hold on OncoMed's ipafricept

September 5, 2014 1:54 AM UTC

OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said FDA lifted a partial hold on Phase Ib trials of oncology candidate ipafricept ( Fzd8-Fc, OMP-54F28), a Wnt signaling antagonist. The agency placed the hold in June after the company halted the trials due to mild to moderate bone-related adverse events.

According to OncoMed, FDA lifted the partial hold after reviewing safety and efficacy data and revised study protocols such as altered dosing regimens, risk mitigation measures, and modified enrollment criteria. ...