6/19/2014 8:25:52 AM
REDWOOD CITY, Calif., June 18, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), reported on continued discussions begun last week with the U.S. Food and Drug Administration (FDA) regarding the company's FZD8-Fc (OMP-54F28) Phase 1 program. The FDA's Division of Oncology Products 1 (DOP1) agreed with OncoMed's voluntary halt, and today informed the company that, as a formality, a partial clinical hold has been placed on Phase 1 clinical trials of FZD8-Fc. The 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 the FDA reiterated its concurrence with the 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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