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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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September 29, 2014
07:17 EDTOMEDOncoMed data supports phase 2 ALPINE study of tarextumab
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September 28, 2014
14:23 EDTOMEDOncoMed demcizumab trials show 'encouraging' safety and anti-tumor activity
OncoMed Pharmaceuticals presented safety and efficacy data from two Phase 1b clinical trials of demcizumab in pancreatic cancer and non-small cell lung cancer, NSCLC, at the European Society for Medical Oncology 2014 Congress in Madrid, Spain. Results from the Phase 1b studies demonstrate that demcizumab, in combination with standard-of-care chemotherapy, is well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed. Encouraging tumor response rates were presented at ESMO from a study of demcizumab with gemcitabine or gemcitabine plus Abraxane in patients with first-line pancreatic cancer, and from the study of demcizumab plus pemetrexed and carboplatin for the first-line treatment of Stage III/IV NSCLC. OncoMed's Phase 1b studies identified the demcizumab dosing schedules for the company's planned randomized Phase 2 proof-of-concept trials.

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