On June 13, 2014 OncoMed Pharmaceuticals reported discussion with the U.S. Food and Drug Administration (FDA) about vantictumab’s (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28) Phase 1 Wnt pathway programs (NCT01973309; NCT01957007; NCT02005315; NCT01345201) (Press release OncoMed, JUN 13, 2014, View Source [SID:1234500577]). The FDA informed the company that a partial clinical hold has been placed on Phase 1 clinical trials of vantictumab until revised protocols have been submitted and concurred with. The company reported that, according to the FDA, this action is being taken in view of OncoMed’s decision to voluntarily halt enrollment and dosing in the ongoing vantictumab Phase 1 trials.

The FDA concurred with OncoMed’s plan to continue dosing of a patient in the single-agent Phase 1a vantictumab clinical trial who has remained on treatment for greater than 700 days progression free without significant drug-related adverse effects. The FDA also concurred with OncoMed’s plan to continue dosing a patient in the single-agent Phase 1a Fzd8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects.

“As we announced this morning, we are analyzing the data in hand with the investigators and academic bone expert advisors to assess the adverse events observed in these trials and develop revised clinical trial protocols. Today’s discussion with the FDA advanced the process to determine the best path forward. We remain committed to evaluating vantictumab and Fzd8-Fc as possible therapies for cancer patients,” stated Paul J. Hastings, Chairman and CEO of OncoMed.