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news.OncoMed Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration’s (FDA) Department of Orphan Products Development for its demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer.
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Currently, OncoMed is conducting a Phase Ib clinical trial of demcizumab in combination with Abraxane (nab-paclitaxel) and gemcitabine in first-line Stage IV pancreatic cancer patients.
OncoMed chairman and CEO Paul J Hastings noted that the company is 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 data 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," Hastings added.
Demcizumab, a humanized monoclonal antibody, inhibits Delta-Like Ligand 4 (DLL4) in the notch signaling pathway. OncoMed developed demcizumab in collaboration with Celgene.
Currently, two Phase Ib combination trials of demcizumab are ongoing. The first trial is in combination with standard-of-care gemcitabine and Abraxane (nab-paclitaxel) in first-line advanced pancreatic cancer patients.
The second trial is in combination with standard-of-care carboplatin and pemetrexed (Alimta) in patients with first-line advanced non-small cell lung cancer.
Additionally, a Phase Ib/II trial of demcizumab and paclitaxel is ongoing in patients with platinum-resistant ovarian cancer at The University of Texas MD Anderson Cancer Center. In January 2014, the company presented interim data from the demcizumab clinical study in pancreatic patients at the Gastrointestinal Cancers Symposium held in San Francisco.