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.
About Demcizumab (Anti-DLL4, OMP-21M18)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. Interim data from the demcizumab clinical study in pancreatic patients were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA. Data from the ongoing demcizumab NSCLC Phase 1b study were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Demcizumab is part of OncoMed's collaboration with Celgene Corporation. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), anti-Notch 2/3 (OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP-18R5), and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3, with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be found at the company's website: www.oncomed.com . Forward-Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed's expectations regarding the success of Phase 1b clinical trials for demcizumab and a favorable safety profile for demcizumab; the successful advancement of demcizumab to randomized Phase 2 clinical trials and the timing of that advancement; the potential of demcizumab to significantly impact cancer treatment and the clinical outcome of patients with cancer, including pancreatic cancer; and the timing of Investigational New Drug filings for OncoMed's product candidates, including anti-DLL4/anti-VEGF bispecific and anti-RSPO3. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed's dependence on its collaboration partners, including GSK, Bayer and Celgene, for the funding of its partnered programs; OncoMed's ability to raise capital to support the development of its unpartnered programs; OncoMed's dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed's ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed's ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed's dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed's patents or proprietary rights; and the ability of OncoMed's proprietary rights to protect its technologies and product candidates. OncoMed undertakes no obligation to update or revise any forward-looking statements. . For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission on March 18, 2014, and OncoMed's periodic reports on Form 10-K and Form 10-Q that OncoMed files from time to time in the future .
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