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February 18, 2014
08:37 EDTOMED, BAYRYOncoMed begins second Phase 1b clinical trial for OMP-54F28 with sorafenib
OncoMed Pharmaceuticals (OMED) announced that it has started a multi-center Phase 1b clinical trial of OMP-54F28 with sorafenib in hepatocellular cancer, or HCC. OMP-54F28 is a first-in-class Wnt-pathway-targeting decoy receptor and is part of OncoMed's collaboration with Bayer Pharma AG (BAYRY). This is the second of three Phase 1b trials for OMP-54F28 to begin patient enrollment; earlier this year OncoMed initiated a Phase 1b of OMP-54F28 with nab-paclitaxel and gemcitabine in pancreatic cancer. The Phase 1b clinical trial is a dose-escalation study of OMP-54F28 in combination with sorafenib in patients with first-line locally advanced or metastatic HCC. 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 sorafenib. 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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October 1, 2015
07:31 EDTOMEDLeerink to hold a roundtable
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September 28, 2015
08:13 EDTOMEDOncoMed pipeline being underappreciated, says Jefferies
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07:52 EDTBAYRYIIR Holdings to hold a conference
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September 27, 2015
14:20 EDTBAYRYBayer says receives FDA approval for Betaconnect autoinjector
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September 25, 2015
09:07 EDTBAYRYBayer says Eylea recommended for EU approval in additional indication
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07:22 EDTBAYRYEuropean Society for Medical Oncology to hold a conference
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06:12 EDTBAYRYFDA panel excoriates Bayer for Essure contraceptive device, NY Times reports
A panel of experts collected by the FDA criticized Bayer for manufacturing a contraceptive device, Essure, without collecting data that they say could have helped anticipate risks for women, the New York Times reports. The device has received thousands of complaints from women claiming they were hurt by it, the report says. Reference Link
September 24, 2015
07:45 EDTBAYRYFDA Obstetrics and Gynecology Devices Panel to hold a meeting
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