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February 20, 2014
08:57 EDTOMED, BAYRYOncoMed commences third Phase 1b clinical trial for OMP-54F28
OncoMed Pharmaceuticals (OMED) announced the initiation of patient treatment for its third multi-center Phase 1b clinical trial of OMP-54F28 with carboplatin and paclitaxel in patients with platinum-sensitive ovarian cancer. OMP-54F28 is a first-in-class decoy receptor targeting the Wnt pathway and is part of OncoMed's collaboration with Bayer Pharma AG (BAYRY). The Phase 1b clinical trial of OMP-54F28 in combination with carboplatin and paclitaxel is a dose-escalation study in patients with recurrent platinum-sensitive ovarian cancer. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with carboplatin and paclitaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics and pharmacodynamics of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.
News For OMED;BAYRY From The Last 14 Days
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September 16, 2014
07:31 EDTBAYRYEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 8, 2014
07:15 EDTBAYRYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
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.
07:22 EDTBAYRYBayer unit aims to invest $1B before FY16 in U.S., Reuters says
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05:37 EDTBAYRYRegeneron submits application for Eylea injection in Japan for macular edema
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