Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2007-09-11
2010-06-08
Puttlitz, Karl J (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
07732490
ABSTRACT:
The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.
REFERENCES:
patent: 4690918 (1987-09-01), Beppu et al.
patent: 5055608 (1991-10-01), Marks et al.
patent: 5175191 (1992-12-01), Marks et al.
patent: 5369108 (1994-11-01), Breslow et al.
patent: 5608108 (1997-03-01), Marks et al.
patent: 5654333 (1997-08-01), Samid
patent: 5700811 (1997-12-01), Breslow et al.
patent: 5773474 (1998-06-01), Breslow et al.
patent: 5932616 (1999-08-01), Breslow et al.
patent: 6087367 (2000-07-01), Breslow et al.
patent: 6231880 (2001-05-01), Perrine
patent: 6239176 (2001-05-01), Nudelman et al.
patent: 6262116 (2001-07-01), Pandolfi et al.
patent: 6451334 (2002-09-01), Perrine
patent: 6469058 (2002-10-01), Grove et al.
patent: 6495719 (2002-12-01), Lan-Hargest et al.
patent: 6511990 (2003-01-01), Breslow et al.
patent: 6905669 (2005-06-01), DiMartino
patent: 7148257 (2006-12-01), Bacopoulos et al.
patent: 7375137 (2008-05-01), Bacopoulos et al.
patent: 7399787 (2008-07-01), Chiao et al.
patent: 2002/0183388 (2002-12-01), Gudas et al.
patent: 2003/0082666 (2003-05-01), Kammer et al.
patent: 2003/0114525 (2003-06-01), Kammer et al.
patent: 2003/0161830 (2003-08-01), Jackson et al.
patent: 2003/0235588 (2003-12-01), Richon et al.
patent: 2004/0002506 (2004-01-01), Breslow et al.
patent: 2004/0072735 (2004-04-01), Richon et al.
patent: 2004/0087631 (2004-05-01), Bacopoulos et al.
patent: 2004/0122101 (2004-06-01), Miller et al.
patent: 2004/0127522 (2004-07-01), Chiao et al.
patent: 2004/0127523 (2004-07-01), Bacopoulos et al.
patent: 2004/0132643 (2004-07-01), Fojo et al.
patent: 2004/0132825 (2004-07-01), Bacopoulos et al.
patent: 2004/0167184 (2004-08-01), Wiech et al.
patent: 2004/0266818 (2004-12-01), Breslow et al.
patent: 2005/0004007 (2005-01-01), Grant et al.
patent: 2006/0079551 (2006-04-01), Richon et al.
patent: 2006/0167103 (2006-07-01), Bacopoulos et al.
patent: 2006/0276547 (2006-12-01), Bacopoulos et al.
patent: 2007/0060614 (2007-03-01), Bacopoulos et al.
patent: 2007/0117815 (2007-05-01), Pluda et al.
patent: 2007/0190022 (2007-08-01), Bacopoulos et al.
patent: 2007/0197473 (2007-08-01), Frankel et al.
patent: 2008/0194692 (2008-08-01), Miller et al.
patent: 2008/0221138 (2008-09-01), Bunn et al.
patent: 2008/0227862 (2008-09-01), Richon et al.
patent: 2008/0228005 (2008-09-01), Miller
patent: 2008/0249179 (2008-10-01), Bacooulos et al.
patent: 2009/0012175 (2009-01-01), Bacopoulos et al.
patent: 2009/0042992 (2009-02-01), Miller et al.
patent: 2009/0054720 (2009-02-01), Sgouros et al.
patent: 0547000 (2003-06-01), None
patent: 10-262694 (1998-10-01), None
patent: WO 95/31977 (1995-11-01), None
patent: WO 98/39965 (1998-09-01), None
patent: WO 98/40080 (1998-09-01), None
patent: WO 98/55449 (1998-10-01), None
patent: WO 99/38525 (1999-08-01), None
patent: WO 00/21979 (2000-04-01), None
patent: WO 00/71703 (2000-11-01), None
patent: WO 01/16106 (2001-03-01), None
patent: WO 01/18171 (2001-03-01), None
patent: WO 01/29199 (2001-04-01), None
patent: WO 01/38322 (2001-05-01), None
patent: WO 01/70675 (2001-09-01), None
patent: WO 02/15921 (2002-02-01), None
patent: WO 02/22577 (2002-03-01), None
patent: WO 02/30879 (2002-04-01), None
patent: WO 02/46144 (2002-06-01), None
patent: WO 02/055017 (2002-07-01), None
patent: WO 02/085400 (2002-10-01), None
patent: WO 03/013493 (2003-02-01), None
patent: WO 03/075839 (2003-09-01), None
patent: WO 2007/022408 (2007-02-01), None
patent: WO 2007/056162 (2007-05-01), None
Butler et al. Cancer Research, 2000, vol. 60 pp. 5165-5170.
Kelly et al. Proceedings of ASCO, 2002, vol. 21, p. 6b, entry 1831.
Ryan et al. (2003); “A Phase I Trial of an Oral Histone Deacetylase Inhibitor, MS-275, in Advanced Solid Tumor and Lymphoma Patients”; Proc. Am. Soc. Clin. Oncol. 22; 2003 ASCO Annual Meeting, Abstract No. 802.
Jan. 10, 2007 Office Action in U.S. Appl. No. 10/616,649.
Sep. 20, 2007 Office Action in U.S. Appl. No. 10/616,649.
Jan. 11, 2005 Office Action in U.S. Appl. No. 10/650,025.
Jul. 6, 2005 Office Action in U.S. Appl. No. 10/650,025.
Oct. 11, 2005 Office Action in U.S. Appl. No. 10/665,079.
Apr. 19, 2006 Office Action in U.S. Appl. No. 10/665,079.
Dec. 15, 2006 Office Action in U.S. Appl. No. 10/665,079.
Jul. 12, 2007 Office Action in U.S. Appl. No. 10/665,079.
Sep. 23, 2005 Office Action in U.S. Appl. No. 10/692,523.
Apr. 21, 2006 Office Action in U.S. Appl. No. 10/692,523.
Dec. 29, 2006 Office Action in U.S. Appl. No. 10/692,523.
Sep. 20, 2007 Office Action in U.S. Appl. No. 10/692,523.
Mar. 17, 2008 Office Action in U.S. Appl. No. 10/692,523.
Oct. 12, 2005 Office Action in U.S. Appl. No. 10/413,422.
Jun. 29, 2006 Office Action in U.S. Appl. No. 10/413,422.
Dec. 22, 2006 Advisory Action in U.S. Appl. No. 10/413,422.
May 17, 2007 Office Action in U.S. Appl. No. 10/413,422.
Mar. 5, 2007 Office Action in U.S. Appl. No. 11/282,420.
Nov. 26, 2007 Office Action in U.S. Appl. No. 11/282,420.
Marks et al. (2000).J. of the Natl. Cancer Institute92: 1210-1215.
Marks et al. (2001).Clinical Cancer Res.7: 759-760.
Marks et al. (2001).Curr. Opin. In Oncology13: 477-483.
Marks et al. (2001).Nature Reviews1: 194-202.
Marshall et al. (2002). J. Exp. Therapeutics and Oncology 2: 325-332.
Miller et al. (2003).J Med Chem.46: 5097-5116.
Munster et al. (2001).Cancer Res.61: 8492-8497.
Niitsu, N et al., Molecular Pharmacology, (2000), vol. 58, pp. 27-36, “Anticancer Derivative of Butyric Acid (Pivalyloxymethyl Butyrate) Specifically Potentiates the Cytotoxicity of Doxorubicin and Daunorubicin Through the Suppression of Microsomal Glycosidic Activity”.
Nimmanapalli, R et al., American Society of Hematology, (Dec. 6-10, 2002), 14 pages, “Co-treatment with the histone deacetylase inhibitor suberoylanilide hydroxamic acid (SAHA) enhances Gleevee-induced apoptosis of Ber-Abl positive human acute leukemia cells”.
Nimmanapalli, R et al., Blood (2003), vol. 101, No. 8, pp. 3236-3239, “Cotreatment with the histone deacetylase inhibitor suberoylanilide hydroxamic acid (SAHA) enhances imatinib-induced apoptosis of Bcr-Abl-positive human acute leukemia cells”.
O'Connor et al. (2001).Journal of the American Society of Hematology611a, Abstract No. 2562.
O'Connor et al. (2002). “Clinical experience of the histone deacetylase inhibitor suberoylanalide hydroxamic acid (SAHA) in heavily pre-treated patients with aggressive non-hodgkin's lymphoma (NHL0 and hodgkin's disease (HD)).”American Society of Clinical Oncology, Dec. 6-10, 2002, Abstract No. 4742.
Orr, D et al., 2000 ASCO Annual Meeting, Abstract No. 763, “Phase I Pharmacokinetic (PK) Study of CI-994 in Combination with Gemcitabine (GEM) in Patients with Advanced Solid Tumors”.
Phase I clinical trial of oral suberoylanilide hydroxamic acid—SAHA (msk390) in patients with advanced solid tumors and hematologic malignancies; first patient dosed in Aug. 2001 at Memorial Sloan Kettering Cancer Center. SAHA gelatin capsules containing SAHA and excipients were administered to patients. The SAHA was prepared according to methods in Example 1 of U.S. Appl. No. 10/379,149.
Piekarz et al. (2001). Blood 98: 2865-2868.
Polack, A et al., The EMBO Journal, (1993), vol. 12, No. 10, pp. 3913-3920, “Regulatory Elements in the Immunoglobulin Kappa Locus Induce c-myc Activation and the Promoter Shift in Burkitt's Lymphoma Cells&
Chiao Judy H.
Kelly William Kevin
Miller Thomas A.
Richon Victoria M.
Elrifi, Esq. Ivor R.
Merck HDAC Research, LLC
Mintz Levin Cohn Ferris Glovsky and Popeo PC
Puttlitz Karl J
Sloan-Kettering Institute for Cancer Research
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