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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 4, 2014
18:28 EDTOMEDOn The Fly: After Hours Movers
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16:49 EDTOMEDOncoMed up 6% in after hours trading after FDA lifts partial hold on ipafricept
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16:27 EDTOMEDFDA removes partial clinical hold on OncoMed ipafricept
OncoMed Pharmaceuticals announced that the FDA removed the partial clinical hold on the company's ipafricept phase 1 clinical trials. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards receive and approve the revised trial protocols. Ipafricept is being studied in combination with standard-of-care in three Phase 1b studies. OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA's Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

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