(12) United States Patent (10) Patent No.: US 6,599,912 B1 Au Et Al

(12) United States Patent (10) Patent No.: US 6,599,912 B1 Au Et Al

USOO65999 12B1 (12) United States Patent (10) Patent No.: US 6,599,912 B1 Au et al. (45) Date of Patent: Jul. 29, 2003 (54) METHODS AND COMPOSITIONS FOR Rubio, Eur, J Cancer 31:244-251, 1995. MODULATING CELL PROLIFERATION AND Small, et al., J. Clin Onc., 18:1440–1450, 2000. CELL DEATH Soliven, et al., Muscle & Nerve, 20:83-91, 1997. (76) Inventors: Jessie L. -S. Au, 2287 Palmleaf Ct., Sturla, et al., Clin. Cancer Res. (Supp), 5:43, 1999. Columbus, OH (US) 43235; Guillaume Swain, et al., Invest. New Drugs 13:55-62, 1995. Wientjes, 2287 Palmleaf Ct., Tu, et al., Clin. Cancer Res., 4:1193–1201, 1998. Columbus, OH (US) 43235 Wang, et al., Cancer Res., 57:1750–1757, 1997. Wang, et al., Exper. Cell Res., 238:177-187. 1998. (*) Notice: Subject to any disclaimer, the term of this Westermann, et al., Cancer Chemother. Pharmacol., patent is extended or adjusted under 35 46:57–62, 2000. U.S.C. 154(b) by 0 days. Wellstein, et al., J. Natl. Cancer Inst., 83:716–720, 1991. Wild, et al., Microvasc. Res., 59:368-376, 2000. (21) Appl. No.: 09/587,559 Motzer, et al., Cancer Res., 2:5775–5779, 1992. (22) Filed: Jun. 5, 2000 Motzer, et al., Cancer, 72:33.13–3317, 1993. Myers, et al., J. Clin. Onc., 10:881–889, 1992. Related U.S. Application Data Nguyen, et al., Anticancer Res., 13:2143-2148, 1993. (60) Provisional application No. 60/187,445, filed on Mar. 7, PDQ Clinical Trial Database (http://www.nci.nih.gov). 2000, provisional application No. 60/172,031, filed on Dec. 23, 1999, provisional application No. 60/165.983, filed on Ramirez, et al., Invest. New Drugs, 13:51–53, 1995. Nov. 17, 1999, and provisional application No. 60/137,345, Rapoport, et al., Ann. Onc., 4:567-573, 1993. filed on Jun. 3, 1999. Reed, et al., Eur. J. Cancer, 28A:864-866, 1992. (51) Int. Cl." ................................................ A61K 31/44 Robbins, et al., Arch. Otolaryngol. 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(74) Attorney, Agent, or Firm Mueller and Smith, LPA 5,486,509 A 1/1996 Jimenez et al. ............. 514/167 (57) ABSTRACT 5,574,026 A 11/1996 Backer et al. .............. 514/152 5,597.830 A 1/1997 Kilohs Methods and compositions for modulating the FGF effect on 5,716,981 A 2/1998 Hunter et al. ............... 514/449 the Sensitivity of malignant and normal cells to anticancer 5,767,110 A 6/1998 Klohs et al. ......... ... 514/119 agents are provided. In particular, methods and composi 5,783,568 A 7/1998 Schlessinger et al.......... 514/53 tions for inhibiting FGF-induced resistance to a broad Spec 6,013.477 A 1/2000 Greene et al. ............. 435/69.1 trum of anticancer agents in Solid and Soft-tissue tumors, FOREIGN PATENT DOCUMENTS metastatic lesions, leukemia and lymphoma are provided. Preferably, the compositions include at least one FGF inhibi EP O 455 422 A2 6/1991 tor in combination with a cytotoxic agents, e.g., antimicro WO WO9934796 7/1999 tubule agents, topoisomerase I inhibitors, topoisomerase II WO WO9960O23 11/1999 inhibitors, antimetabolites, mitotic inhibitors, alkylating WO WO9965515 12/1999 agents, intercalating agents, agents capable of interfering OTHER PUBLICATIONS with a signal transduction pathway (e.g., g., a protein kinase Kiefer et al., 1990, Biochemistry, 87:6985–6989.* C inhibitor, e.g., an anti-hormone, e.g., an antibody against Kato, et al., Cancer Research, 54:5143-5147.* growth factor receptors), an agent that promotes apoptosis Kano, et al., Biotherapy, 10:530-532.* and/or necrosis, and interferon, an interleukin, a tumor Falcone, et al., Tumori, 84.666-668.* necrosis factor, and radiation. Pesenti, et al., Br. J. 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