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OncoMed Pharmaceuticals Initiates First Phase 1b Clinical Trial Of OMP-54F28 (Fzd8-Fc) With Nab-Paclitaxel (Abraxane(R)) And Gemcitabine In Pancreatic Cancer

REDWOOD CITY, Calif., Jan. 13, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with nab-paclitaxel (Abraxane ®) and gemcitabine in pancreatic cancer. This trial is the first of three Phase 1b trials for OMP-54F28 expected to begin patient enrollment in the next few months as part of OncoMed's collaboration with Bayer Pharma AG. This study follows on the recent initiation of OncoMed's Phase 1b program for the Wnt-pathway-targeting antibody vantictumab (OMP-18R5, Anti-Fzd7).

The Phase 1b clinical trial is a dose escalation study of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with first-line Stage IV pancreatic 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 nab-paclitaxel and gemcitabine. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) 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.

Colin Weekes, M.D. Ph.D., Assistant Professor at the University of Colorado, Aurora, CO, is the Principal Investigator who treated the first patient enrolled in this study. Dr. Weekes commented, "Metastatic pancreatic cancer is a devastating disease and these patients are in need of additional therapeutic options. OMP-54F28 has shown impressive combination efficacy with Abraxane and gemcitabine in preclinical models for pancreas cancer. We are looking forward to learning more about this novel investigational combination in pancreas cancer patients."

Four additional investigators and clinical sites are expected to participate in this trial: Jordan Berlin, M.D., Vanderbilt University, Nashville, TN; Efrat Dotan, M.D., Fox Chase Cancer Center, Philadelphia, PA; Heinz-Josef Lenz, M.D., University of Southern California, Los Angeles, CA; and Bert O'Neil, M.D., Indiana University, Indianapolis, IN.

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