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June 13, 2014
17:53 EDTOMEDOncoMed says Phase 1 clinical trials of vantictumab put on partial hold by FDA
OncoMed Pharmaceuticals discussed the vantictumab and Fzd8-Fc Phase 1 Wnt pathway programs with the U.S. FDA. 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.
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April 16, 2015
06:35 EDTOMEDOncoMed's Demcizumab shows positive Phase 1b clinical trial results
OncoMed presented new data from the Phase 1b clinical trial of demcizumab in patients with first-line advanced non-small cell lung cancer at the European Lung Cancer Conference. Demcizumab is a first-in-class monoclonal antibody targeting DLL4 with anti-cancer stem cell, dysangiogenesis and potential immune modulatory properties. Of 40 patients evaluable for efficacy, the overall RECIST response rate was 50% and an additional 15 patients had a best response of stable disease, yielding a clinical benefit rate of 88%. Median progression-free survival was 5.3 months and 5.8 months for the continuous and truncated cohorts, respectively. Prolonged PFS and OS were observed for a subset of patients treated with continuous demcizumab. A randomized Phase 2 trial of demcizumab with carboplatin and pemetrexed in first-line non-squamous NSCLC has been initiated and is enrolling subjects in Europe, Australia, and the United States.

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