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February 18, 2014
08:37 EDTBAYRY, OMEDOncoMed 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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January 16, 2015
14:33 EDTOMEDOncoMed presents final Phase 1b data for Tarextumab
OncoMed Pharmaceuticals presented final safety, efficacy and biomarker data from the company's Phase 1b "ALPINE" clinical trial of tarextumab in 40 patients with frontline metastatic pancreatic cancer. Tarextumab was generally well tolerated when administered with gemcitabine and Abraxane, with manageable, on-target drug-related toxicities. The Phase 2 dose of tarextumab was determined to be 15 mg/kg every two weeks in combination with the standard-of-care. Among patients evaluable for response using RECIST criteria, 38% achieved partial responses, with an additional 35% achieving stable disease for an overall clinical benefit rate of 73%. Median progression-free survival and overall survival values for the three drug combination of tarextumab-gemcitabine-Abraxane were 5.6 months and 11.6 months, respectively, for all patients treated with the three-drug combination. The data presented included biomarker analyses that showed that among patients whose tumor samples had elevated levels of Notch3 gene expression, trends toward higher response rates and longer survival were noted, as compared to patients with low Notch3 expression. Median PFS and OS for patients with high Notch 3 expression were 6.6 months and 14.6 months, respectively. Given the small sample size and potential imbalances in patient characteristics, these encouraging preliminary efficacy and predictive biomarker observations are being assessed in the ongoing randomized, placebo-controlled, Phase 2 ALPINE trial
January 15, 2015
08:36 EDTOMEDOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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07:59 EDTBAYRYAmerican Society of Clinical Oncology to hold a symposium
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January 12, 2015
08:42 EDTOMEDOncoMed backs view that existing cash, potential milestones may fund operations
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