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June 13, 2014
08:42 EDTOMEDOncoMed halts enrollment, dosing in Phase 1 Vantictumab, Fzd8-Fc trials
OncoMed Pharmaceuticals announced that the company has voluntarily halted patient enrollment and dosing in its ongoing Phase 1 clinical trials of its two Wnt pathway inhibitor programs, vantictumab and Fzd8-Fc. OncoMed 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 patients treated with vantictumab and 2 of 41 patients treated with Fzd8-Fc. After careful analysis of the recent mild-to-moderate adverse event incidents, OncoMed 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 FDA and subsequently to the clinical study sites. The amendments for the Phase 1b combination trials will include 1) modified dosing regimens, such as lower and less frequent dosing, 2) updated risk mitigation measures, such as increased monitoring and bone protection strategies, and 3) 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. In parallel, the company intends 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. OncoMed has notified the FDA of these actions.
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November 21, 2014
08:17 EDTOMEDOncoMed presents data from tarextumab, demcizumab trials
OncoMed Pharmaceuticals presented data in two posters highlighting the company's translational research and biomarker efforts for its tarextumab and demcizumab clinical programs Jakob Dupont, M.D., OncoMed's Chief Medical Officer, stated, "The data from the Phase 1b clinical trials of tarextumab and demcizumab demonstrate that our preclinical understanding of on-target drug activity and predictive biomarkers is being validated in the clinic as we study actual patient tumor samples. In the ALPINE Phase 1b study in advanced pancreatic cancer, we see clear evidence that tarextumab modulates the Notch cancer stem cell pathway in patient samples and that there is a potential association between tumors that show higher levels of Notch3 gene expression and best responses to tarextumab treatment. In the demcizumab poster presentation, a case study is described from our Phase 1b trial in pancreatic cancer in which the tumor response to treatment that occurred in the clinic correlates with what we observe using patient-derived xenograft models. This may provide insights into the development of potential biomarkers of response to demcizumab treatment in that program."
November 19, 2014
07:54 EDTOMEDOncoMed presents biomarker-focused clinical data from Anti-Notch1 Phase 1a trial
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November 12, 2014
07:53 EDTOMEDLeerink to hold a tour
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