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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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July 24, 2014
13:06 EDTBAYRYBayer treatment for systemic sclerosis receives FDA orphan designation
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07:12 EDTBAYRYEvogene announces amendment to Bayer wheat agreement
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July 21, 2014
07:14 EDTBAYRYAmerican Association of Physicists in Medicine to hold annual meeting
56th Annual Meeting of AAPM to be held in Austin, Texas on July 20-25.
July 16, 2014
08:32 EDTOMEDOncoMed initiates Phase 2 ALPINE trial of tarextumab
OncoMed Pharmaceuticals announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE", or Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety, clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab, being studied for the treatment of pancreatic cancer. Tarextumab is being tested in combination with Abraxane plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival, or PFS, of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.

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