Tyrosine kinase inhibitors

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C546S093000

Reexamination Certificate

active

07893081

ABSTRACT:
This invention relates to salt forms of the compound N-[(2R)-1,4-dioxan-2-ylmethyl]-N-methyl-N′-[3-(1-methyl-1H-pyrazol-4-yl)-5-oxo-5H-benzo[4,5]cyclohepta[1,2-b]pyridin-7-yl]sulfamide, an inhibitor of tyrosine kinases, in particular the receptor tyrosine kinase MET, that are useful in the treatment of cellular proliferative diseases, for example cancer, hyperplasias, restenosis, cardiac hypertrophy, immune disorders and inflammation. In particular, the invention relates to the sodium salt of N-[(2R)-1,4-dioxan-2-ylmethyl]-N-methyl-N′-[3-(1-methyl-1H-pyrazol-4-yl)-5-oxo-5H-benzo[4,5]cyclohepta[1,2-b]pyridin-7-yl]sulfamide.

REFERENCES:
patent: WO 03/084931 (2003-10-01), None
patent: WO 2004/058742 (2004-07-01), None
patent: WO 2007/002254 (2007-01-01), None
patent: WO 2007002258 (2007-01-01), None
patent: WO 2007/050380 (2007-05-01), None
patent: WO 2007/050383 (2007-05-01), None
patent: WO 2007/050401 (2007-05-01), None
patent: WO 2008/008310 (2008-01-01), None
Ma, PC et al. Cancer Research, vol. 65, No. 4, pp. 1479-1488 (2005), Functional expression and mutations of c-Met and its therapeutic inhibition with SU11274 and small interfering RNA in non-small cell lung cancer.
Ma, PC et al. Cancer Research, vol. 63, pp. 6272-6281 (2003), “c-MET mutational analysis in small cell lung cancer: novel juxtamembrane domain mutations regulating cytoskeletal functions”.
Christensen, JG et al., Cancer Research., vol. 63, pp. 7345-7355 (2003), “A selective small molecule inhibitor of c-Met kinase inhibits c-Met-dependent phenotypes in vitro and exhibits cytoreductive antitumor activity in vivo”.
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Christensen, JG et al., Cancer Letters, vol. 225, pp. 1-26 (2005), “c-Met as a target for human cancer and characterization of inhibitors for therapeutic intervention”.
Puri, N et al., Cancer Research, vol. 67, No. 8, pp. 3529-3534 (2007), “A selective small molecule inhibitor of c-Met, PHA665752, inhibits tumorigenicity and angiogenesis in mouse lung cancer xenografts”.
Zou, HY et al., Cancer Research, vol. 67, No. 9, pp. 4408-4417 (2007), “An orally available small-molecule inhibitor of c-Met, PF-2341066, exhibits cytoreductive antitumor efficacy through antiproliferative and antiangiogenic mechanisms”.
Cassinelli, G et al., Molecular Cancer Therapeutics, vol. 5, No. 9, pp. 2388-2397 (2006), “Inhibition of c-Met and prevention of spontaneous metastatic spreading by the 2-indolinone RPI-1”.
Martens, T et al., Clinical Cancer Research, vol. 12, No. 20, pp. 6144-6152 (2006), “A novel one-armed anti-c-Met antibody inhibits glioblastoma growth in vivo”.
Ross, R et al., Poster B249, 2007 AARC-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Oct. 2007, “A Phase 2 Study of the Dual MET/VEGFR2 Inhibitor XL880 in Patients (pts) with Papillary Renal Carcinoma (PRC)”.
Office Communication from the USPTO mailed Apr. 28, 2008 with a three-month reply due of Jul. 28, 2008.
Amendment and Response dated Jun. 4, 2008 in reply to the Office Action mailed Apr. 28, 2008 from the USPTO.
Office Communication from the USPTO mailed Jul. 29, 2008 with a three-month reply due of Oct. 29, 2008.
Amendment and Response dated Sep. 5, 2008 in reply to the Office Action mailed Jul. 29, 2008 from the USPTO.
Notice of Allowance and Fees due Communication from the USPTO mailed Dec. 1, 2008 with a three-month reply due of Mar. 1, 2009.
Assignment Recordal with Recordation Cover Sheet faxed to USPTO on Feb. 23, 2009.
Issue Fee Transmittal faxed to USPTO on Feb. 25, 2009.

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