OncoMed falls on trial halts
OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) fell as much as $6.15 (25%) on Friday before closing the day off $2.19 to $22.71 after halting enrollment and dosing in Phase Ib trials evaluating the company's two Wnt pathway inhibitors to treat cancer. The move came as a result of mild to moderate bone-related adverse events in open-label, dose-escalation trials separately evaluating vantictumab ( OMP-18R5) and Fzd8-Fc ( OMP-54F28) in combination with other therapies. After market close, OncoMed said FDA placed vantictumab on a partial clinical hold.
OncoMed said the AEs were grade 1/2 fractures in line with the type seen with chemotherapies like tamoxifen and aromatase inhibitors. The company plans to submit amended protocols to FDA and the study sites' institutional review boards. The amendments will include modified dosing regimens and updated risk mitigation measures. ...