Title:
PREVENTIVE OR THERAPEUTIC AGENT FOR HTLV-1-ASSOCIATED MYELOPATHY USING LOW-DOSE ANTI-CCR4 ANTIBODY
Document Type and Number:
WIPO Patent Application WO/2018/159845
Kind Code:
A1
Abstract:
The purpose of the present invention is to provide a novel therapeutic or preventive agent for human T-cell leukemia virus-1-associated myelopathy (HAM), characterized by containing an anti-human CC-chemokine receptor 4 (CCR4) antibody or a fragment of the antibody as an active ingredient and by a dosage regimen of said antibody or of a fragment of the antibody. The present invention pertains to a therapeutic or preventative agent for HAM, which is characterized by containing an anti-human CCR4 antibody or a fragment of the antibody as an active ingredient and in that the antibody or fragment of the antibody is administered at a low dose.
Inventors:
YAMANO YOSHIHISA (JP)
Application Number:
PCT/JP2018/008166
Publication Date:
September 07, 2018
Filing Date:
March 02, 2018
Export Citation:
Assignee:
UNIV SCHOOL ST MARIANNA MEDICINE (JP)
KYOWA HAKKO KIRIN CO LTD (JP)
KYOWA HAKKO KIRIN CO LTD (JP)
International Classes:
A61K39/395; A61K31/52; A61K31/573; A61K31/706; A61K38/13; A61K45/00; A61P19/00; A61P31/12; A61P35/02; A61P37/06; A61P43/00
Domestic Patent References:
| WO2014007303A1 | 2014-01-09 | |||
| WO2014007303A1 | 2014-01-09 | |||
| WO2005035586A1 | 2005-04-21 | |||
| WO2002031140A1 | 2002-04-18 | |||
| WO2000061739A1 | 2000-10-19 | |||
| WO2005070963A1 | 2005-08-04 |
Foreign References:
| JP2010017130A | 2010-01-28 | |||
| JP2010100578A | 2010-05-06 | |||
| US20070148165A1 | 2007-06-28 | |||
| US6737056B1 | 2004-05-18 | |||
| US7297775B2 | 2007-11-20 | |||
| US7317091B2 | 2008-01-08 | |||
| JP2017039506A | 2017-02-23 |
Other References:
ISHIDA, T. ET AL.: "Defucosy lated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T- cell leukemia-lymphoma: a multicenter phase II study", J. CLIN. ONCOL., vol. 30, no. 8, 6 February 2012 (2012-02-06), pages 837 - 42, XP055207303
OGURA, M. ET AL.: "Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-CC chemokine receptor 4 antibody, in patients with relapsed peripheral T- cell lymphoma and cutaneous T- cell lymphoma", J. CLIN. ONCOL., vol. 32, no. 11, 10 April 2014 (2014-04-10), pages 1157 - 1163, XP055345042
YAMANO, YOSHIHISA: "Investigator-initiated clinical trial of humanized anti-CCR4 antibody in HAM", CLINICAL EVALUATION, vol. 43, no. 2, January 2016 (2016-01-01), pages 418 - 421, XP009516088, ISSN: 0300-3051
ARAYA, NATSUMI ET AL.: "Developing novel treatments for HTLV-1-associated myelopathy (HAM) by investigating molecular pathomechanisms", JAPANESE JOURNAL OF CLINICAL IMMUNOLOGY, vol. 39, no. 3, 2016, pages 207 - 212, XP055538314
YAMANO, YOSHIHISA: "The background to develop a humanized anti CCR4 antibody as a treatment for HAM", NEUROLOGICAL THERAPEUTICS, vol. 34, no. 4, February 2018 (2018-02-01), pages 453 - 457, XP055538317
ARAYA, NATSUMI ET AL.: "Advancement in research and treatment of adult T- cell leukemia/lymphoma (ATL): Molecular pathogenesis and treatment of HTLV-1 associated myelopathy (HAM)", HEMATOLOGY, vol. 74, no. 3, 2017, pages 373 - 379, XP009516471, ISSN: 2185-582X
FUKUSHIMA, NORIYASU ET AL.: "VIII. Emerging Treatment of HTLV-1-associated Diseases: Future Prospects", THE JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE - NIHON NAIKA GAKKAI ZASSHI, vol. 106, no. 7, July 2017 (2017-07-01), pages 1417 - 1422, XP055538328
YAMAUCHI, J. ET AL.: "Mogamulizumab, an anti-CCR4 antibody, targets human T-lymphotropic virus type 1-infected CD 8+ and CD 4+ T cells to treat associated myelopathy", J. INFECT. DIS., vol. 211, no. 2, August 2015 (2015-08-01), pages 238 - 248, XP055538330
UCHIYAMA ET AL., BLOOD, vol. 50, 1977, pages 481 - 492
GESSAIN ET AL., LANCET, vol. 2, 1985, pages 407 - 410
OSAME ET AL., LANCET, vol. 1, 1986, pages 1031 - 1032
KAPLAN ET AL., J. AQUIR. IMMUNE DEFI. SYNDRO., vol. 3, 1990, pages 1096 - 1101
FUZII ET AL., LIFE SCIENCES, vol. 104, 2014, pages 9 - 14
NAKAGAWA ET AL., J. NEUROVIROL., vol. 1, 1995, pages 50 - 61
YAMANO ET AL., THE JOURNAL OF CLINICAL INVESTIGATION, vol. 115, 2005, pages 1361 - 1368
OLIND ET AL., ARCH. NEUROL., vol. 63, 2006, pages 1560 - 1566
YAMANO ET AL., PLOS ONE, vol. 4, 2009, pages e6517
ARAYA ET AL., VIRUSES, vol. 3, 2011, pages 1532 - 1548
YAMANO ET AL., CLINICAL AND EXPEROMENTAL NEUROIMMUNOLOGY, vol. 6, 2015, pages 395 - 401
NIWA ET AL., CANCER RES., vol. 64, 2004, pages 2127 - 2133
ISHII ET AL., CLIN. CANCER RES., vol. 16, 2010, pages 1520 - 1531
POTELIGEO (REGISTERED TRADEMARK), INTRAVENOUS INFUSION 20 MG, PACKAGE INSERT, May 2015 (2015-05-01)
D. PODSIADLO ET AL., JOURNAL OF AMERICAN GERIATRICS SOCIETY, vol. 39, 1991, pages 142 - 148
R. W. BOHANNON ET AL., PHYSIGCAL THERAPY, vol. 67, no. 2, 1987, pages 206 - 207
S. IZUMO ET AL., NEUROLOGY, vol. 46, no. 4, 1996, pages 1016 - 1021
YAMANO ET AL., BLOOD, vol. 99, no. 1, 2002, pages 88 - 94
YAMANO ET AL., J. EXP. MED., vol. 199, 2004, pages 1367 - 1377
YAMANO ET AL., J. CLIN INVEST., vol. 115, 2005, pages 1361 - 1368
SATO ET AL., PLOS NEGLECTED TROPICAL DISEASE, vol. 7, no. 10, 2013, pages e2479
SATO ET AL., PLOS NEGLECTED TROPICAL DISEASES, vol. 7, no. 10, 2013, pages e2479
"UniProtKB/Swiss-Prot", Database accession no. P51679
J. BIOL. CHEM., vol. 271, 1996, pages 21514
J. EXP. MED., vol. 185, 1997, pages 1595
J. BIOL. CHEM., vol. 272, 1997, pages 25229
KABAT ET AL.: "Sequence of Proteins of immunological interests", 1991
KOBAYASHI ET AL., CLINICAL CANCER RESEARCH, vol. 20, no. 11, 2014, pages 2851 - 61
OSAME M.: "Human Retrovirology: Htlv.", 1990, RAVEN PRESS, LTD., article "Review of WHO Kagoshima Meeting and Diagnostic Guidelines for HAM/TSP", pages: 191 - 7
YAMANO ET AL., CLINICAL AND EXPERIMENTAL NEUROIMMUNOLOGY, vol. 6, 2015, pages 395 - 401
ISHIDA ET AL., J. CLIN. ONCOL., vol. 30, no. 8, 2012, pages 837 - 842
See also references of EP 3590535A4
OGURA, M. ET AL.: "Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-CC chemokine receptor 4 antibody, in patients with relapsed peripheral T- cell lymphoma and cutaneous T- cell lymphoma", J. CLIN. ONCOL., vol. 32, no. 11, 10 April 2014 (2014-04-10), pages 1157 - 1163, XP055345042
YAMANO, YOSHIHISA: "Investigator-initiated clinical trial of humanized anti-CCR4 antibody in HAM", CLINICAL EVALUATION, vol. 43, no. 2, January 2016 (2016-01-01), pages 418 - 421, XP009516088, ISSN: 0300-3051
ARAYA, NATSUMI ET AL.: "Developing novel treatments for HTLV-1-associated myelopathy (HAM) by investigating molecular pathomechanisms", JAPANESE JOURNAL OF CLINICAL IMMUNOLOGY, vol. 39, no. 3, 2016, pages 207 - 212, XP055538314
YAMANO, YOSHIHISA: "The background to develop a humanized anti CCR4 antibody as a treatment for HAM", NEUROLOGICAL THERAPEUTICS, vol. 34, no. 4, February 2018 (2018-02-01), pages 453 - 457, XP055538317
ARAYA, NATSUMI ET AL.: "Advancement in research and treatment of adult T- cell leukemia/lymphoma (ATL): Molecular pathogenesis and treatment of HTLV-1 associated myelopathy (HAM)", HEMATOLOGY, vol. 74, no. 3, 2017, pages 373 - 379, XP009516471, ISSN: 2185-582X
FUKUSHIMA, NORIYASU ET AL.: "VIII. Emerging Treatment of HTLV-1-associated Diseases: Future Prospects", THE JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE - NIHON NAIKA GAKKAI ZASSHI, vol. 106, no. 7, July 2017 (2017-07-01), pages 1417 - 1422, XP055538328
YAMAUCHI, J. ET AL.: "Mogamulizumab, an anti-CCR4 antibody, targets human T-lymphotropic virus type 1-infected CD 8+ and CD 4+ T cells to treat associated myelopathy", J. INFECT. DIS., vol. 211, no. 2, August 2015 (2015-08-01), pages 238 - 248, XP055538330
UCHIYAMA ET AL., BLOOD, vol. 50, 1977, pages 481 - 492
GESSAIN ET AL., LANCET, vol. 2, 1985, pages 407 - 410
OSAME ET AL., LANCET, vol. 1, 1986, pages 1031 - 1032
KAPLAN ET AL., J. AQUIR. IMMUNE DEFI. SYNDRO., vol. 3, 1990, pages 1096 - 1101
FUZII ET AL., LIFE SCIENCES, vol. 104, 2014, pages 9 - 14
NAKAGAWA ET AL., J. NEUROVIROL., vol. 1, 1995, pages 50 - 61
YAMANO ET AL., THE JOURNAL OF CLINICAL INVESTIGATION, vol. 115, 2005, pages 1361 - 1368
OLIND ET AL., ARCH. NEUROL., vol. 63, 2006, pages 1560 - 1566
YAMANO ET AL., PLOS ONE, vol. 4, 2009, pages e6517
ARAYA ET AL., VIRUSES, vol. 3, 2011, pages 1532 - 1548
YAMANO ET AL., CLINICAL AND EXPEROMENTAL NEUROIMMUNOLOGY, vol. 6, 2015, pages 395 - 401
NIWA ET AL., CANCER RES., vol. 64, 2004, pages 2127 - 2133
ISHII ET AL., CLIN. CANCER RES., vol. 16, 2010, pages 1520 - 1531
POTELIGEO (REGISTERED TRADEMARK), INTRAVENOUS INFUSION 20 MG, PACKAGE INSERT, May 2015 (2015-05-01)
D. PODSIADLO ET AL., JOURNAL OF AMERICAN GERIATRICS SOCIETY, vol. 39, 1991, pages 142 - 148
R. W. BOHANNON ET AL., PHYSIGCAL THERAPY, vol. 67, no. 2, 1987, pages 206 - 207
S. IZUMO ET AL., NEUROLOGY, vol. 46, no. 4, 1996, pages 1016 - 1021
YAMANO ET AL., BLOOD, vol. 99, no. 1, 2002, pages 88 - 94
YAMANO ET AL., J. EXP. MED., vol. 199, 2004, pages 1367 - 1377
YAMANO ET AL., J. CLIN INVEST., vol. 115, 2005, pages 1361 - 1368
SATO ET AL., PLOS NEGLECTED TROPICAL DISEASE, vol. 7, no. 10, 2013, pages e2479
SATO ET AL., PLOS NEGLECTED TROPICAL DISEASES, vol. 7, no. 10, 2013, pages e2479
"UniProtKB/Swiss-Prot", Database accession no. P51679
J. BIOL. CHEM., vol. 271, 1996, pages 21514
J. EXP. MED., vol. 185, 1997, pages 1595
J. BIOL. CHEM., vol. 272, 1997, pages 25229
KABAT ET AL.: "Sequence of Proteins of immunological interests", 1991
KOBAYASHI ET AL., CLINICAL CANCER RESEARCH, vol. 20, no. 11, 2014, pages 2851 - 61
OSAME M.: "Human Retrovirology: Htlv.", 1990, RAVEN PRESS, LTD., article "Review of WHO Kagoshima Meeting and Diagnostic Guidelines for HAM/TSP", pages: 191 - 7
YAMANO ET AL., CLINICAL AND EXPERIMENTAL NEUROIMMUNOLOGY, vol. 6, 2015, pages 395 - 401
ISHIDA ET AL., J. CLIN. ONCOL., vol. 30, no. 8, 2012, pages 837 - 842
See also references of EP 3590535A4
Attorney, Agent or Firm:
EIKOH PATENT FIRM, P.C. (JP)
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