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1 Bayer Pharmaceuticals Corporation, West Haven, Connecticut; and 2 Onyx Pharmaceuticals, Richmond, California
The RAS/RAF signaling pathway is an important mediator of tumor cell proliferation and angiogenesis. The novel bi-aryl urea BAY 43-9006 is a potent inhibitor of Raf-1, a member of the RAF/MEK/ERK signaling pathway. Additional characterization showed that BAY 43-9006 suppresses both wild-type and V599E mutant BRAF activity in vitro. In addition, BAY 43-9006 demonstrated significant activity against several receptor tyrosine kinases involved in neovascularization and tumor progression, including vascular endothelial growth factor receptor (VEGFR)-2, VEGFR-3, platelet-derived growth factor receptor ß, Flt-3, and c-KIT. In cellular mechanistic assays, BAY 43-9006 demonstrated inhibition of the mitogen-activated protein kinase pathway in colon, pancreatic, and breast tumor cell lines expressing mutant KRAS or wild-type or mutant BRAF, whereas nonsmall-cell lung cancer cell lines expressing mutant KRAS were insensitive to inhibition of the mitogen-activated protein kinase pathway by BAY 43-9006. Potent inhibition of VEGFR-2, platelet-derived growth factor receptor ß, and VEGFR-3 cellular receptor autophosphorylation was also observed for BAY 43-9006. Once daily oral dosing of BAY 43-9006 demonstrated broad-spectrum antitumor activity in colon, breast, and nonsmall-cell lung cancer xenograft models. Immunohistochemistry demonstrated a close association between inhibition of tumor growth and inhibition of the extracellular signal-regulated kinases (ERKs) 1/2 phosphorylation in two of three xenograft models examined, consistent with inhibition of the RAF/MEK/ERK pathway in some but not all models. Additional analyses of microvessel density and microvessel area in the same tumor sections using antimurine CD31 antibodies demonstrated significant inhibition of neovascularization in all three of the xenograft models. These data demonstrate that BAY 43-9006 is a novel dual action RAF kinase and VEGFR inhibitor that targets tumor cell proliferation and tumor angiogenesis.
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D. F. McDermott, J. A. Sosman, R. Gonzalez, F. S. Hodi, G. P. Linette, J. Richards, J. W. Jakub, M. Beeram, S. Tarantolo, S. Agarwala, et al. Double-Blind Randomized Phase II Study of the Combination of Sorafenib and Dacarbazine in Patients With Advanced Melanoma: A Report From the 11715 Study Group J. Clin. Oncol., May 1, 2008; 26(13): 2178 - 2185. [Abstract] [Full Text] [PDF] |
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M. Eto, Y. Kamiryo, A. Takeuchi, M. Harano, K. Tatsugami, M. Harada, K. Kiyoshima, M. Hamaguchi, T. Teshima, M. Tsuneyoshi, et al. Posttransplant Administration of Cyclophosphamide and Donor Lymphocyte Infusion Induces Potent Antitumor Immunity to Solid Tumor Clin. Cancer Res., May 1, 2008; 14(9): 2833 - 2840. [Abstract] [Full Text] [PDF] |
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A. X. Zhu and G. K. Abou-Alfa Expanding the Treatment Options for Hepatocellular Carcinoma: Combining Transarterial Chemoembolization With Radiofrequency Ablation JAMA, April 9, 2008; 299(14): 1716 - 1718. [Full Text] [PDF] |
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G. Ambrosini, H. S. Cheema, S. Seelman, A. Teed, E. B. Sambol, S. Singer, and G. K. Schwartz Sorafenib inhibits growth and mitogen-activated protein kinase signaling in malignant peripheral nerve sheath cells Mol. Cancer Ther., April 1, 2008; 7(4): 890 - 896. [Abstract] [Full Text] [PDF] |
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L. Moreno-Vinasco, M. Gomberg-Maitland, M. L. Maitland, A. A. Desai, P. A. Singleton, S. Sammani, L. Sam, Y. Liu, A. N. Husain, R. M. Lang, et al. Genomic assessment of a multikinase inhibitor, sorafenib, in a rodent model of pulmonary hypertension Physiol Genomics, April 1, 2008; 33(2): 278 - 291. [Abstract] [Full Text] [PDF] |
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Y. Ding, E. A. Boguslawski, B. D. Berghuis, J. J. Young, Z. Zhang, K. Hardy, K. Furge, E. Kort, A. E. Frankel, R. V. Hay, et al. Mitogen-activated protein kinase kinase signaling promotes growth and vascularization of fibrosarcoma Mol. Cancer Ther., March 1, 2008; 7(3): 648 - 658. [Abstract] [Full Text] [PDF] |
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J. Tsai, J. T. Lee, W. Wang, J. Zhang, H. Cho, S. Mamo, R. Bremer, S. Gillette, J. Kong, N. K. Haass, et al. From the Cover: Discovery of a selective inhibitor of oncogenic B-Raf kinase with potent antimelanoma activity PNAS, February 26, 2008; 105(8): 3041 - 3046. [Abstract] [Full Text] [PDF] |
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W. Zhang, M. Konopleva, Y.-x. Shi, T. McQueen, D. Harris, X. Ling, Z. Estrov, A. Quintas-Cardama, D. Small, J. Cortes, et al. Mutant FLT3: A Direct Target of Sorafenib in Acute Myelogenous Leukemia J Natl Cancer Inst, February 6, 2008; 100(3): 184 - 198. [Abstract] [Full Text] [PDF] |
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J. J. Hiles and J. M. Kolesar Role of sunitinib and sorafenib in the treatment of metastatic renal cell carcinoma Am. J. Health Syst. Pharm., January 15, 2008; 65(2): 123 - 131. [Abstract] [Full Text] [PDF] |
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W. Feng, R. E. Brown, C. D. Trung, W. Li, L. Wang, T. Khoury, S. Alrawi, J. Yao, K. Xia, and D. Tan Morphoproteomic Profile of mTOR, Ras/Raf Kinase/ERK, and NF-{kappa}B Pathways in Human Gastric Adenocarcinoma Ann. Clin. Lab. Sci., January 1, 2008; 38(3): 195 - 209. [Abstract] [Full Text] [PDF] |
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D. W. Hedley, S. Chow, C. Goolsby, and T. V. Shankey Pharmacodynamic Monitoring of Molecular-Targeted Agents in the Peripheral Blood of Leukemia Patients Using Flow Cytometry Toxicol Pathol, January 1, 2008; 36(1): 133 - 139. [Abstract] [Full Text] [PDF] |
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J. A. Blansfield, D. Caragacianu, H. R. Alexander III, M. A. Tangrea, S. Y. Morita, D. Lorang, P. Schafer, G. Muller, D. Stirling, R. E. Royal, et al. Combining Agents that Target the Tumor Microenvironment Improves the Efficacy of Anticancer Therapy Clin. Cancer Res., January 1, 2008; 14(1): 270 - 280. [Abstract] [Full Text] [PDF] |
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D. W. Ball, N. Jin, D. M. Rosen, A. Dackiw, D. Sidransky, M. Xing, and B. D. Nelkin Selective Growth Inhibition in BRAF Mutant Thyroid Cancer by the Mitogen-Activated Protein Kinase Kinase 1/2 Inhibitor AZD6244 J. Clin. Endocrinol. Metab., December 1, 2007; 92(12): 4712 - 4718. [Abstract] [Full Text] [PDF] |
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L. J. Costa and H. A. Drabkin Renal Cell Carcinoma: New Developments in Molecular Biology and Potential for Targeted Therapies Oncologist, December 1, 2007; 12(12): 1404 - 1415. [Abstract] [Full Text] [PDF] |
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M. J. Ratain and R. H. Glassman Biomarkers in Phase I Oncology Trials: Signal, Noise, or Expensive Distraction? Clin. Cancer Res., November 15, 2007; 13(22): 6545 - 6548. [Full Text] [PDF] |
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H. Akaza, T. Tsukamoto, M. Murai, K. Nakajima, and S. Naito Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Sorafenib in Japanese Patients with Advanced Renal Cell Carcinoma Jpn. J. Clin. Oncol., October 19, 2007; (2007) hym095v1. [Abstract] [Full Text] [PDF] |
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I. Plaza-Menacho, L. Mologni, E. Sala, C. Gambacorti-Passerini, A. I. Magee, T. P. Links, R. M. W. Hofstra, D. Barford, and C. M. Isacke Sorafenib Functions to Potently Suppress RET Tyrosine Kinase Activity by Direct Enzymatic Inhibition and Promoting RET Lysosomal Degradation Independent of Proteasomal Targeting J. Biol. Chem., October 5, 2007; 282(40): 29230 - 29240. [Abstract] [Full Text] [PDF] |
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L. Ying, A. B. Hofseth, D. D. Browning, M. Nagarkatti, P. S. Nagarkatti, and L. J. Hofseth Nitric Oxide Inactivates the Retinoblastoma Pathway in Chronic Inflammation Cancer Res., October 1, 2007; 67(19): 9286 - 9293. [Abstract] [Full Text] [PDF] |
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J. P. Plastaras, S.-H. Kim, Y. Y. Liu, D. T. Dicker, J. F. Dorsey, J. McDonough, G. Cerniglia, R. R. Rajendran, A. Gupta, A. K. Rustgi, et al. Cell Cycle Dependent and Schedule-Dependent Antitumor Effects of Sorafenib Combined with Radiation Cancer Res., October 1, 2007; 67(19): 9443 - 9454. [Abstract] [Full Text] [PDF] |
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B. Martinez-Poveda, R. Munoz-Chapuli, S. Rodriguez-Nieto, J. M. Quintela, A. Fernandez, M.-A. Medina, and A. R. Quesada IB05204, a dichloropyridodithienotriazine, inhibits angiogenesis in vitro and in vivo Mol. Cancer Ther., October 1, 2007; 6(10): 2675 - 2685. [Abstract] [Full Text] [PDF] |
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T. Ishii, H. Sootome, Y. Yagi, K. Yamashita, T. Noumi, and N. Noro A Selective Cellular Screening Assay for B-Raf and c-Raf Kinases J Biomol Screen, September 1, 2007; 12(6): 818 - 827. [Abstract] [PDF] |
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M. Rahmani, T. K. Nguyen, P. Dent, and S. Grant The Multikinase Inhibitor Sorafenib Induces Apoptosis in Highly Imatinib Mesylate-Resistant Bcr/Abl+ Human Leukemia Cells in Association with Signal Transducer and Activator of Transcription 5 Inhibition and Myeloid Cell Leukemia-1 Down-Regulation Mol. Pharmacol., September 1, 2007; 72(3): 788 - 795. [Abstract] [Full Text] [PDF] |
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C. Elser, L. L. Siu, E. Winquist, M. Agulnik, G. R. Pond, S. F. Chin, P. Francis, R. Cheiken, J. Elting, A. McNabola, et al. Phase II Trial of Sorafenib in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Nasopharyngeal Carcinoma J. Clin. Oncol., August 20, 2007; 25(24): 3766 - 3773. [Abstract] [Full Text] [PDF] |
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I. Duran, S. J. Hotte, H. Hirte, E. X. Chen, M. MacLean, S. Turner, L. Duan, G. R. Pond, C. Lathia, S. Walsh, et al. Phase I Targeted Combination Trial of Sorafenib and Erlotinib in Patients with Advanced Solid Tumors Clin. Cancer Res., August 15, 2007; 13(16): 4849 - 4857. [Abstract] [Full Text] [PDF] |
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T. Guo, N. P. Agaram, G. C. Wong, G. Hom, D. D'Adamo, R. G. Maki, G. K. Schwartz, D. Veach, B. D. Clarkson, S. Singer, et al. Sorafenib Inhibits the Imatinib-Resistant KITT670I Gatekeeper Mutation in Gastrointestinal Stromal Tumor Clin. Cancer Res., August 15, 2007; 13(16): 4874 - 4881. [Abstract] [Full Text] [PDF] |
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J. A. Gollob, W. K. Rathmell, T. M. Richmond, C. B. Marino, E. K. Miller, G. Grigson, C. Watkins, L. Gu, B. L. Peterson, and J. J. Wright Phase II Trial of Sorafenib Plus Interferon Alfa-2b As First- or Second-Line Therapy in Patients With Metastatic Renal Cell Cancer J. Clin. Oncol., August 1, 2007; 25(22): 3288 - 3295. [Abstract] [Full Text] [PDF] |
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