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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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November 21, 2014
08:17 EDTOMEDOncoMed presents data from tarextumab, demcizumab trials
OncoMed Pharmaceuticals presented data in two posters highlighting the company's translational research and biomarker efforts for its tarextumab and demcizumab clinical programs Jakob Dupont, M.D., OncoMed's Chief Medical Officer, stated, "The data from the Phase 1b clinical trials of tarextumab and demcizumab demonstrate that our preclinical understanding of on-target drug activity and predictive biomarkers is being validated in the clinic as we study actual patient tumor samples. In the ALPINE Phase 1b study in advanced pancreatic cancer, we see clear evidence that tarextumab modulates the Notch cancer stem cell pathway in patient samples and that there is a potential association between tumors that show higher levels of Notch3 gene expression and best responses to tarextumab treatment. In the demcizumab poster presentation, a case study is described from our Phase 1b trial in pancreatic cancer in which the tumor response to treatment that occurred in the clinic correlates with what we observe using patient-derived xenograft models. This may provide insights into the development of potential biomarkers of response to demcizumab treatment in that program."
November 19, 2014
07:54 EDTOMEDOncoMed presents biomarker-focused clinical data from Anti-Notch1 Phase 1a trial
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November 12, 2014
07:53 EDTOMEDLeerink to hold a tour
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