SAN FRANCISCO, Jan. 17, 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, presented data today from its ongoing Phase 1b clinical trial of demcizumab (OMP-21M18; anti-DLL4) in first-line Stage IV pancreatic cancer patients at the 2014 Gastrointestinal Cancers Symposium being held in San Francisco, California. These are the first reported data from the Phase 1b study of demcizumab with gemcitabine to include the addition of Abaxane® (nab-paclitaxel). Demcizumab is part of OncoMed's collaboration with Celgene Corporation.
Dr. Antonio Cubillo of START-Madrid, the presenting author for the poster presentation commented, "Advanced pancreatic cancer is a challenging malignancy with poor survival outcomes for many patients and new drugs that can further improve outcomes are needed. The early data for the combination of demcizumab with Abraxane and gemcitabine are potentially encouraging both from a safety and clinical activity perspective."
Demcizumab was generally well tolerated in combination with both gemcitabine and Abraxane with fatigue, hypertension, nausea and vomiting being the most common drug-related toxicities. No demcizumab-related reversible cardiotoxicity events have occurred with the implementation of regular monitoring, a truncated treatment approach and cardioprotective medication, if indicated. The combination of gemcitabine with or without Abraxane did not appear to influence the pharmacokinetics of demcizumab.
Three of the six (50%) evaluable patients who received the demcizumab/gemcitabine/Abraxane combination had partial responses as measured by RECIST and two patients had stable disease resulting in a clinical benefit rate of 83%. A randomized Phase 2 clinical trial in patients with first-line pancreatic cancer is planned for the second half of 2014.
"These are the first results from this ongoing study to include the addition of Abraxane to the demcizumab plus gemcitabine combination, building off the positive interim data presented at the October 2013 AACR-NCI-EORTC meeting in Boston," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "To date, demcizumab has been well tolerated as part of combination therapy, and we are seeing early indications of notable anti-cancer activity with the triple-drug combination."
Antonio Cubillo, M.D., of START-Madrid presented these results in a poster titled, "A phase 1b study of the anticancer stem cell agent demcizumab (DEM) and gemcitabine (GEM) with or without paclitaxel protein bound particles (nab-paclitaxel) in patients with pancreatic cancer" (Abstract #259; Poster Board B52).
Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed, commented, "The data presented today add to the growing body of clinical evidence supporting the anti-tumor activity of OncoMed's therapeutic candidates. Based on the encouraging safety and response data achieved to date for demcizumab, we anticipate advancing demcizumab into a randomized Phase 2 clinical study in combination with gemcitabine and Abraxane in first-line pancreatic cancer in 2014."
About Demcizumab (OMP-21M18; Anti-DLL4)
Demcizumab (OMP-21M18) 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® in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard-of-care carboplatin and pemetrexed (Alimta®) in first-line advanced non-small cell lung cancer (NSCLC) patients. 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. Data from the demcizumab NSCLC and pancreatic cancer Phase 1b trials were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA, in October 2013. Updated data from the demcizumab clinical study in pancreatic patients were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA. Demcizumab is part of OncoMed's collaboration with Celgene Corporation.
About Cancer Stem Cells
Cancer stem cells, or CSCs, are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs via a process called self-renewal and the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor. OncoMed's product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells. OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (Anti-DLL4, OMP-21M18), OMP-59R5 (Anti-Notch2/3), OMP-52M51 (Anti-Notch1), vantictumab (Anti-Fzd7, OMP-18R5), and OMP-54F28 (Fzd8-Fc), 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 and Anti-RSPO3, with Investigational New Drug filings planned for as early as 2014. 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:
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; the potential of OncoMed's product candidates to significantly impact cancer treatment and the clinical outcome of patients with cancer, including the potential of demcizumab to improve patient outcomes in pancreatic cancer in particular; the timing of clinical trials for OncoMed's product candidates, including demcizumab; 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 Prospectus filed with the Securities and Exchange Commission on July 18, 2013 and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30,2013, filed with the Securities and Exchange Commission on November 13, 2013.
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