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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.
News For OMED From The Last 14 Days
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April 28, 2015
10:51 EDTOMEDOncoMed management to meet with JMP Securities
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April 23, 2015
10:01 EDTOMEDOncoMed to host research and development day
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April 22, 2015
08:35 EDTOMEDOncoMed initiates dosing in randomized Phase 2 clinical trial of demcizumab
OncoMed Pharmaceuticals announced that dosing has begun in the randomized Phase 2 clinical trial of demcizumab in patients with first-line metastatic pancreatic cancer. The double-blind, placebo-controlled Phase 2 "YOSEMITE" clinical trial is designed to compare the efficacy and safety of demcizumab combined with standard of care Abraxane plus gemcitabine in patients with first-line metastatic pancreatic cancer. The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, response rate, duration of response, safety, immunogenicity and pharmacokinetics. Approximately 200 patients will be randomized into one of three study arms. Patients in Arm 1 will receive Abraxane plus gemcitabine plus placebo. Patients in Arm 2 will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for 70 days. Patients in Arm 3 will receive standard of care plus a second course of demcizumab following a 100-day wash out period. The Phase 2 trial is being conducted at approximately 50 centers in the U.S., Canada, Europe and Australia.
April 21, 2015
13:06 EDTOMEDOncoMed presents data on stem cell programs at AACR
OncoMed Pharmaceuticals announced data from seven poster presentations at the American Association of Cancer Research Annual Meeting."We are pleased to have presented seven posters highlighting our ongoing discovery and development capabilities," said Paul J. Hastings, Chairman and CEO of OncoMed. "Leveraging our proprietary human tumor bank, human xenograft models and murine models, we have tested new combinations of our antibodies with standard-of-care chemotherapy and immunotherapy, as well as maximized optimal dosing regimens for these therapies. Our biomarker programs focus on patient selection for our clinical trials, and OncoMed continues to pursue breakthrough anti-cancer stem cell and immuno-oncology discoveries with multiple new targets and pathways."
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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