OncoMed Gets Orphan Drug Designation For Demcizumab In Pancreatic Cancer

(RTTNews) - OncoMed Pharmaceuticals Inc. (OMED) announced that the U.S. Food and Drug Administration or 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.

Based on the encouraging safety and response data achieved to date for demcizumab in the company's Phase 1a and 1b clinical studies, OncoMed said it anticipates advancing demcizumab into a randomized Phase 2 clinical study in combination with Abraxane and gemcitabine in first-line pancreatic cancer in 2014.

Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (DLL4) in the Notch signaling pathway. Two Phase 1b 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, and 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 (NSCLC).

In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at The University of Texas MD Anderson Cancer Center.