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OncoMed Pharmaceuticals Inc provides update on FZD8-Fc (OMP-54F28) Phase I clinical trials

Wednesday, 18 Jun 2014 04:45pm EDT 

OncoMed Pharmaceuticals Inc:Says on continued discussions begun last week with U.S. Food and Drug Administration (FDA) regarding company's FZD8-Fc (OMP-54F28) Phase 1 program.FDA's Division of Oncology Products 1 (DOP1) agreed with OncoMed's voluntary halt, and informed company that, as formality, partial clinical hold has been placed on Phase 1 clinical trials of FZD8-Fc.Partial clinical hold on FZD8-Fc will remain in effect until OncoMed provides DOP1 with requested additional data and proposed protocol amendments have been submitted to and concurred with by the FDA.OncoMed also reported that FDA reiterated its concurrence with company's plan to continue dosing of 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. 

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23 Oct 2014