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OncoMed Receives Orphan Drug Designation From The FDA For Demcizumab In Pancreatic Cancer

REDWOOD CITY, Calif., May 2, 2014 (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 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 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."

According to the American Cancer Society, there are approximately 46,000 new cases of pancreatic cancer each year in the United States. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. Rates of pancreatic cancer have been increasing over the past ten years and it is now the fourth-leading cause of cancer-related deaths. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year.

The FDA's Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. This designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.

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