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SU5416 Is a Potent and Selective Inhibitor of the Vascular Endothelial Growth Factor Receptor (Flk-1/KDR) That Inhibits Tyrosine Kinase Catalysis, Tumor Vascularization, and Growth of Multiple Tumor Types

SUGEN, Inc., South San Francisco, California 94080 [T. A. T. F., L. K. S., L. S., C. T., H. A., T. J. P., Y. H. K., R. S., X. W., K. P. H., G. M]; Max-Planck Institut fur Physiologische and Klinische Forschung, Bad Nauheim, Germany [W. R.]; and Max-Planck Institut fur Biochemie, Martinsried, Germany 82152 [A. U.]

SU5416, a novel synthetic compound, is a potent and selective inhibitor of the Flk-1/KDR receptor tyrosine kinase that is presently under evaluation in Phase I clinical studies for the treatment of human cancers. SU5416 was shown to inhibit vascular endothelial growth factor-dependent mitogenesis of human endothelial cells without inhibiting the growth of a variety of tumor cells in vitro. In contrast, systemic administration of SU5416 at nontoxic doses in mice resulted in inhibition of subcutaneous tumor growth of cells derived from various tissue origins. The antitumor effect of SU5416 was accompanied by the appearance of pale white tumors that were resected from drug-treated animals, supporting the antiangiogenic property of this agent. These findings support that pharmacological inhibition of the enzymatic activity of the vascular endothelial growth factor receptor represents a novel strategy for limiting the growth of a wide variety of tumor types.

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				A. C. Peterson, S. Swiger, W. M. Stadler, M. Medved, G. Karczmar, and T. F. Gajewski Phase II Study of the Flk-1 Tyrosine Kinase Inhibitor SU5416 in Advanced Melanoma Clin. Cancer Res., June 15, 2004; 10(12): 4048 - 4054. [Abstract] [Full Text] [PDF]

				R. S. Herbst and A. B. Sandler Non-Small Cell Lung Cancer and Antiangiogenic Therapy: What Can Be Expected of Bevacizumab? Oncologist, June 1, 2004; 9(suppl_1): 19 - 26. [Abstract] [Full Text] [PDF]

				W. M. Stadler, D. Cao, N. J. Vogelzang, C. W. Ryan, K. Hoving, R. Wright, T. Karrison, and E. E. Vokes A Randomized Phase II Trial of the Antiangiogenic Agent SU5416 in Hormone-Refractory Prostate Cancer Clin. Cancer Res., May 15, 2004; 10(10): 3365 - 3370. [Abstract] [Full Text] [PDF]

				D. M. Roberts, J. B. Kearney, J. H. Johnson, M. P. Rosenberg, R. Kumar, and V. L. Bautch The Vascular Endothelial Growth Factor (VEGF) Receptor Flt-1 (VEGFR-1) Modulates Flk-1 (VEGFR-2) Signaling During Blood Vessel Formation Am. J. Pathol., May 1, 2004; 164(5): 1531 - 1535. [Abstract] [Full Text] [PDF]

				M. A. Castilla, F. Neria, G. Renedo, D. S. Pereira, F. R. Gonzalez-Pacheco, S. Jimenez, P. Tramon, J. J. P. Deudero, M. V. A. Arroyo, S. Yague, et al. Tumor-induced endothelial cell activation: role of vascular endothelial growth factor Am J Physiol Cell Physiol, May 1, 2004; 286(5): C1170 - C1176. [Abstract] [Full Text] [PDF]

				K. A. Hogan, C. A. Ambler, D. L. Chapman, and V. L. Bautch The neural tube patterns vessels developmentally using the VEGF signaling pathway Development, April 1, 2004; 131(7): 1503 - 1513. [Abstract] [Full Text] [PDF]

				T. Goi, M. Fujioka, Y. Satoh, S. Tabata, K. Koneri, H. Nagano, Y. Hirono, K. Katayama, K. Hirose, and A. Yamaguchi Angiogenesis and Tumor Proliferation/Metastasis of Human Colorectal Cancer Cell Line SW620 Transfected with Endocrine Glands-Derived-Vascular Endothelial Growth Factor, As a New Angiogenic Factor Cancer Res., March 15, 2004; 64(6): 1906 - 1910. [Abstract] [Full Text] [PDF]

				K. Bagrintseva, R. Schwab, T. M. Kohl, S. Schnittger, S. Eichenlaub, J. W. Ellwart, W. Hiddemann, and K. Spiekermann Mutations in the tyrosine kinase domain of FLT3 define a new molecular mechanism of acquired drug resistance to PTK inhibitors in FLT3-ITD-transformed hematopoietic cells Blood, March 15, 2004; 103(6): 2266 - 2275. [Abstract] [Full Text] [PDF]

				S. Madhusudan, G. Deplanque, J. P. Braybrooke, E. Cattell, M. Taylor, P. Price, M. D. Tsaloumas, N. Moore, S. M. Huson, C. Adams, et al. Antiangiogenic Therapy for von Hippel-Lindau Disease JAMA, February 25, 2004; 291(8): 943 - 944. [Full Text] [PDF]

				T. Semba, Y. Funahashi, N. Ono, Y. Yamamoto, N. H. Sugi, M. Asada, K. Yoshimatsu, and T. Wakabayashi An Angiogenesis Inhibitor E7820 Shows Broad-Spectrum Tumor Growth Inhibition in a Xenograft Model: Possible Value of Integrin {alpha}2 on Platelets as a Biological Marker Clin. Cancer Res., February 15, 2004; 10(4): 1430 - 1438. [Abstract] [Full Text] [PDF]

				K. Fukahi, M. Fukasawa, G. Neufeld, J. Itakura, and M. Korc Aberrant Expression of Neuropilin-1 and -2 in Human Pancreatic Cancer Cells Clin. Cancer Res., January 15, 2004; 10(2): 581 - 590. [Abstract] [Full Text] [PDF]

				M. Zangari, E. Anaissie, A. Stopeck, A. Morimoto, N. Tan, J. Lancet, M. Cooper, A. Hannah, G. Garcia-Manero, S. Faderl, et al. Phase II Study of SU5416, a Small Molecule Vascular Endothelial Growth Factor Tyrosine Kinase Receptor Inhibitor, in Patients with Refractory Multiple Myeloma Clin. Cancer Res., January 1, 2004; 10(1): 88 - 95. [Abstract] [Full Text] [PDF]

				A. Abdollahi, K. E. Lipson, A. Sckell, H. Zieher, F. Klenke, D. Poerschke, A. Roth, X. Han, M. Krix, M. Bischof, et al. Combined Therapy with Direct and Indirect Angiogenesis Inhibition Results in Enhanced Antiangiogenic and Antitumor Effects Cancer Res., December 15, 2003; 63(24): 8890 - 8898. [Abstract] [Full Text] [PDF]

				M. E. Daly, A. Makris, M. Reed, and C. E. Lewis Hemostatic Regulators of Tumor Angiogenesis: A Source of Antiangiogenic Agents for Cancer Treatment? J Natl Cancer Inst, November 19, 2003; 95(22): 1660 - 1673. [Abstract] [Full Text] [PDF]

				X. Jiang and J. R. Couchman Perlecan and Tumor Angiogenesis J. Histochem. Cytochem., November 1, 2003; 51(11): 1393 - 1410. [Abstract] [Full Text] [PDF]

				J. A. Sosman Targeting of the VHL-Hypoxia-Inducible Factor-Hypoxia-Induced Gene Pathway for Renal Cell Carcinoma Therapy J. Am. Soc. Nephrol., November 1, 2003; 14(11): 2695 - 2702. [Abstract] [Full Text] [PDF]

				Y. Ueda, T. Yamagishi, K. Samata, H. Ikeya, N. Hirayama, H. Takashima, S. Nakaike, M. Tanaka, and I. Saiki A novel low molecular weight antagonist of vascular endothelial growth factor receptor binding: VGA1155 Mol. Cancer Ther., November 1, 2003; 2(11): 1105 - 1111. [Abstract] [Full Text] [PDF]

				D. Lu, J. Shen, M. D. Vil, H. Zhang, X. Jimenez, P. Bohlen, L. Witte, and Z. Zhu Tailoring in Vitro Selection for a Picomolar Affinity Human Antibody Directed against Vascular Endothelial Growth Factor Receptor 2 for Enhanced Neutralizing Activity J. Biol. Chem., October 31, 2003; 278(44): 43496 - 43507. [Abstract] [Full Text] [PDF]

				D. Saha, K. R. Sekhar, C. Cao, J. D. Morrow, H. Choy, and M. L. Freeman The Antiangiogenic Agent SU5416 Down-Regulates Phorbol Ester-Mediated Induction of Cyclooxygenase 2 Expression by Inhibiting Nicotinamide Adenine Dinucleotide Phosphate Oxidase Activity Cancer Res., October 15, 2003; 63(20): 6920 - 6927. [Abstract] [Full Text] [PDF]

				P. N. Lara Jr., D. I. Quinn, K. Margolin, F. J. Meyers, J. Longmate, P. Frankel, P. C. Mack, C. Turrell, P. Valk, J. Rao, et al. SU5416 Plus Interferon {alpha} in Advanced Renal Cell Carcinoma: A Phase II California Cancer Consortium Study with Biological and Imaging Correlates of Angiogenesis Inhibition Clin. Cancer Res., October 15, 2003; 9(13): 4772 - 4781. [Abstract] [Full Text] [PDF]

				W. Fiedler, R. Mesters, H. Tinnefeld, S. Loges, P. Staib, U. Duhrsen, M. Flasshove, O. G. Ottmann, W. Jung, F. Cavalli, et al. A phase 2 clinical study of SU5416 in patients with refractory acute myeloid leukemia Blood, October 15, 2003; 102(8): 2763 - 2767. [Abstract] [Full Text] [PDF]

				B. R. Stoll, C. Migliorini, A. Kadambi, L. L. Munn, and R. K. Jain A mathematical model of the contribution of endothelial progenitor cells to angiogenesis in tumors: implications for antiangiogenic therapy Blood, October 1, 2003; 102(7): 2555 - 2561. [Abstract] [Full Text] [PDF]

				V. Chhokar and A. L. Tucker Angiogenesis: Basic Mechanisms and Clinical Applications Seminars in Cardiothoracic and Vascular Anesthesia, September 1, 2003; 7(3): 253 - 280. [Abstract] [PDF]

				O. Stoeltzing, W. Liu, N. Reinmuth, A. Parikh, S. A. Ahmad, Y. D. Jung, F. Fan, and L. M. Ellis Angiogenesis and Antiangiogenic Therapy of Colon Cancer Liver Metastasis Ann. Surg. Oncol., August 1, 2003; 10(7): 722 - 733. [Abstract] [Full Text] [PDF]

				F. J. Giles, A. T. Stopeck, L. R. Silverman, J. E. Lancet, M. A. Cooper, A. L. Hannah, J. M. Cherrington, A.-M. O'Farrell, H. A. Yuen, S. G. Louie, et al. SU5416, a small molecule tyrosine kinase receptor inhibitor, has biologic activity in patients with refractory acute myeloid leukemia or myelodysplastic syndromes Blood, August 1, 2003; 102(3): 795 - 801. [Abstract] [Full Text] [PDF]