Demcizumab, a monoclonal antibody that targets the Notch signaling pathway, has been awarded an orphan drug status by the FDA in the treatment of pancreatic cancer.
OncoMed Pharmaceuticals Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that the U.S. Food and Drug Administration (FDA) Department of Orphan Products Development has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer. OncoMed is currently conducting a Phase 1b clinical trial of demcizumab in combination with Abraxane® (nab-paclitaxel) and gemcitabine in first-line Stage IV pancreatic cancer patients.
Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed, commented, "We are very pleased that the FDA designated demcizumab as an orphan drug for the treatment of pancreatic cancer which is a major unmet medical need. Based on the encouraging safety and response achieved to date for demcizumab in OncoMed's Phase 1a and 1b clinical studies, we anticipate advancing demcizumab into a randomized Phase 2 clinical study in combination with Abraxane and gemcitabine in first-line pancreatic cancer in 2014."
Press release: http://bit.ly/1pXsoSR