OncoMed Pharmaceuticals Initiates Third Phase 1b Clinical Trial Of First-in-Class WNT-Pathway-Targeting Antibody Vantictumab (OMP-18R5) With Nab-Paclitaxel (Abraxane(R)) And Gemcitabine In Stage IV Pancreatic Cancer
REDWOOD CITY, Calif., Dec. 4, 2013 (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 Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting antibody vantictumab (OMP-18R5) in combination with nab-paclitaxel (Abraxane ®) and gemcitabine in patients with Stage IV pancreatic cancer. This trial is the third of three Phase 1b trials for vantictumab initiated this year as part of OncoMed's collaboration with Bayer Pharma AG.
The multi-center Phase 1b clinical trial is a dose escalation study that will evaluate safety of vantictumab in combination with Abraxane and gemcitabine and determine a recommended Phase 2 dose for this combination regimen. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) of vantictumab, as well as the pharmacodynamics (PD) and efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab.
"Incidence of pancreatic cancer has been steadily rising. In spite of recent advancements, metastatic pancreatic cancer represents a significant unmet medical need and patients are in need of improved treatment options," said Safi Shahda, M.D., Assistant Professor of Clinical Medicine at Indiana University in Indianapolis, IN, and the Principal Investigator who treated the first patient enrolled in this study. "By targeting cancer stem cells, vantictumab has the potential to augment the clinical benefit of standard chemotherapy in this disease setting. I am particularly excited by the inclusion of biomarker measures in this Phase 1b trial of vantictumab with Abraxane and gemcitabine, which will provide valuable information related to the drug's mechanism of action."The other investigators and clinical sites to participate in the trial are: Jordan Berlin, M.D., Vanderbilt University, Nashville, TN; Steven Cohen, M.D., Fox Chase Cancer Center, Philadelphia, PA; Heinz-Josef Lenz, M.D., University of Southern California, Los Angeles, CA, and Wells Messersmith, M.D., University of Colorado Cancer Center, Aurora, CO.
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