OncoMed Pharmaceuticals Inc. (OMED: Quote) announced Friday that it has voluntarily halted patient enrollment and dosing in its ongoing Phase 1 clinical trials of its two Wnt pathway inhibitor programs, vantictumab (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28).
The company noted that it has been informed by the participating clinical sites of recent on-target mild-to-moderate bone-related adverse events for the two programs. To date, bone-related adverse events have been observed in 8 of 63 (13%) patients treated with vantictumab and 2 of 41 (5%) patients treated with Fzd8-Fc.
After careful analysis of the recent mild-to-moderate adverse event incidents, OncoMed said that it has halted enrollment and dosing in the Phase 1 studies for both programs as a precautionary measure. OncoMed, in conjunction with its academic bone expert advisors and study investigators, continues to analyze the clinical data in order to submit amended protocols to the U.S. Food and Drug Administration or FDA and subsequently to the clinical study sites.
The amendments for the Phase 1b combination trials will include modified dosing regimens, such as lower and less frequent dosing; updated risk mitigation measures, such as increased monitoring and bone protection strategies; and modified enrollment criteria. Enrollment and dosing of new patients is expected to resume once amendments go through the process of review by the FDA and approval by the study sites' institutional review boards (IRBs).
In addition, the company noted that it plans to continue existing or modified dosing of those patients in the completed single-agent Phase 1a clinical trials for both vantictumab and Fzd8-Fc who have remained on treatment with the investigational agent for extended periods of time without disease progression and without significant drug-related adverse events.
OMED, which closed at $24.90 on Thursday, is down 20.88 percent in pre-market activity.
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by RTT Staff Writer
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