OncoMed Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed a partial clinical hold on its demcizumab (OMP-21M18) clinical program. Demcizumab is a humanized monoclonal antibody that targets Delta Like Ligand 4, or DLL4, in the Notch signaling pathway. The company had submitted an extensive data package to the FDA with safety and efficacy results from four demcizumab clinical trials: a Phase 1a solid tumors study and three Phase 1b studies in non-small cell lung cancer (NSCLC), pancreatic cancer and colorectal cancer.

The company plans to initiate new demcizumab clinical trials in 2013 in the United States. Specifically, the company will initiate a Phase 1b/2 study of demcizumab and paclitaxel in patients with epithelial ovarian cancer in collaboration with Drs. Robert Coleman and Anil Sood at the MD Anderson Cancer Center (MDACC) as part of the MDACC Ovarian SPORE grant.

Additionally, the company is planning Phase 2 clinical trials of demcizumab for NSCLC and pancreatic cancer in 2013, to be performed in multiple regions, including the United States.