WO2006023651A2 - Extended treatment of multiple sclerosis - Google Patents

Extended treatment of multiple sclerosis Download PDF

Info

Publication number
WO2006023651A2
WO2006023651A2 PCT/US2005/029407 US2005029407W WO2006023651A2 WO 2006023651 A2 WO2006023651 A2 WO 2006023651A2 US 2005029407 W US2005029407 W US 2005029407W WO 2006023651 A2 WO2006023651 A2 WO 2006023651A2
Authority
WO
WIPO (PCT)
Prior art keywords
vla
months
binding antibody
less
antibody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/029407
Other languages
English (en)
French (fr)
Other versions
WO2006023651A3 (en
Inventor
Michael Panzara
Martin Toal
Frances Lynn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biogen Inc
Biogen MA Inc
Original Assignee
Biogen Idec Inc
Biogen Idec MA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biogen Idec Inc, Biogen Idec MA Inc filed Critical Biogen Idec Inc
Priority to JP2007528011A priority Critical patent/JP2008510714A/ja
Priority to US11/573,823 priority patent/US20090010926A1/en
Priority to EP05804218A priority patent/EP1789086A4/en
Priority to CA002577188A priority patent/CA2577188A1/en
Priority to AU2005277343A priority patent/AU2005277343B2/en
Publication of WO2006023651A2 publication Critical patent/WO2006023651A2/en
Publication of WO2006023651A3 publication Critical patent/WO2006023651A3/en
Anticipated expiration legal-status Critical
Priority to US13/542,407 priority patent/US20120276048A1/en
Priority to US14/561,503 priority patent/US20150175703A1/en
Ceased legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2842—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/215—IFN-beta
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Definitions

  • MS Multiple sclerosis
  • the VLA-4 binding antibody is a full length antibody such as an IgGl, IgG2, IgG3, or IgG4. Typically the antibody is effectively human, human, or humanized.
  • the VLA-4 binding antibody can inhibit VLA-4 interaction with a cognate ligand of VLA-4, e.g., VCAM-I .
  • the VLA-4 binding antibody binds to at least the ⁇ chain of VLA-4, e.g., to the extracellular domain of the ⁇ 4 subunit.
  • the VLA-4 binding antibody recognizes epitope B (e.g., Bl or B2) on the ⁇ chain of VLA-4.
  • VH and VL regions can be further subdivided into regions of hypervariability, termed “complementarity determining regions” ("CDR"), interspersed with regions that are more conserved, termed “framework regions” ("FR").
  • CDR complementarity determining regions
  • FR framework regions
  • the extent of the FR's and CDR's has been precisely defined (see, Kabat, E. A., et ⁇ /. (1991) Sequences of Proteins of Immunological Interest, Fifth Edition, US Department of Health and Human Services, NIH Publication No. 91-3242; and Chothia, C. et al. (1987) J. MoI. Biol. 196:901-917). Kabat definitions are used herein.
  • Treatment can be deemed to be effective if there is a statistically significant difference in the rate or proportion of exacerbation-free or relapse- free patients between the treated group and the placebo group for either of these measurements.
  • time to first exacerbation and exacerbation duration and severity may also be measured.
  • a measure of effectiveness as therapy in this regard is a statistically significant difference in the time to first exacerbation or duration and severity in the treated group compared to control group.
  • An exacerbation-free or relapse-free period of greater than one year, 18 months, or 20 months is particularly noteworthy.
  • Antibodies can be tested for a functional property, e.g., VLA-4 binding, e.g., as described in US Pat. No. 6,602,503.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preliminary Treatment Of Fibers (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Heat Treatment Of Articles (AREA)
PCT/US2005/029407 2004-08-20 2005-08-18 Extended treatment of multiple sclerosis Ceased WO2006023651A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP2007528011A JP2008510714A (ja) 2004-08-20 2005-08-18 多発性硬化症の長期処置
US11/573,823 US20090010926A1 (en) 2004-08-20 2005-08-18 Extended Treatment of Multiple Sclerosis
EP05804218A EP1789086A4 (en) 2004-08-20 2005-08-18 PROLONGED TREATMENT OF MULTIPLE SCLEROSIS
CA002577188A CA2577188A1 (en) 2004-08-20 2005-08-18 Extended treatment of multiple sclerosis
AU2005277343A AU2005277343B2 (en) 2004-08-20 2005-08-18 Extended treatment of multiple sclerosis
US13/542,407 US20120276048A1 (en) 2004-08-20 2012-07-05 Extended treatment of multiple sclerosis
US14/561,503 US20150175703A1 (en) 2004-08-20 2014-12-05 Extended treatment of multiple sclerosis

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US60349504P 2004-08-20 2004-08-20
US60346804P 2004-08-20 2004-08-20
US60347004P 2004-08-20 2004-08-20
US60/603,495 2004-08-20
US60/603,470 2004-08-20
US60/603,468 2004-08-20
US61602304P 2004-10-05 2004-10-05
US60/616,023 2004-10-05

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US11/573,823 A-371-Of-International US20090010926A1 (en) 2004-08-20 2005-08-18 Extended Treatment of Multiple Sclerosis
US13/542,407 Continuation US20120276048A1 (en) 2004-08-20 2012-07-05 Extended treatment of multiple sclerosis

Publications (2)

Publication Number Publication Date
WO2006023651A2 true WO2006023651A2 (en) 2006-03-02
WO2006023651A3 WO2006023651A3 (en) 2006-09-21

Family

ID=35968170

Family Applications (4)

Application Number Title Priority Date Filing Date
PCT/US2005/029407 Ceased WO2006023651A2 (en) 2004-08-20 2005-08-18 Extended treatment of multiple sclerosis
PCT/US2005/029403 Ceased WO2006023649A2 (en) 2004-08-20 2005-08-18 Treatment of severe multiple sclerosis
PCT/US2005/029569 Ceased WO2006036371A2 (en) 2004-08-20 2005-08-18 Combination therapy
PCT/US2005/029368 Ceased WO2006023629A2 (en) 2004-08-20 2005-08-18 Treatment of pediatric multiple sclerosis

Family Applications After (3)

Application Number Title Priority Date Filing Date
PCT/US2005/029403 Ceased WO2006023649A2 (en) 2004-08-20 2005-08-18 Treatment of severe multiple sclerosis
PCT/US2005/029569 Ceased WO2006036371A2 (en) 2004-08-20 2005-08-18 Combination therapy
PCT/US2005/029368 Ceased WO2006023629A2 (en) 2004-08-20 2005-08-18 Treatment of pediatric multiple sclerosis

Country Status (6)

Country Link
US (5) US20080260728A1 (https=)
EP (2) EP2783701A3 (https=)
JP (4) JP2008510714A (https=)
AU (1) AU2005277343B2 (https=)
CA (2) CA2478458A1 (https=)
WO (4) WO2006023651A2 (https=)

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US9326965B2 (en) 2014-02-28 2016-05-03 Banner Life Sciences Llc Controlled release fumarate esters
US9566259B1 (en) 2015-08-31 2017-02-14 Banner Life Sciences Llc Fumarate ester dosage forms
US10098863B2 (en) 2014-02-28 2018-10-16 Banner Life Sciences Llc Fumarate esters
US11084876B2 (en) 2013-02-08 2021-08-10 Amgen Research (Munich) Gmbh Anti-leukocyte adhesion for the mitigation of potential adverse events caused by CD3-specific binding domains

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AU2005277343B2 (en) 2011-07-07
EP1789086A2 (en) 2007-05-30
CA2577188A1 (en) 2006-03-02
CA2478458A1 (en) 2006-02-20
US20150175703A1 (en) 2015-06-25
US20090010926A1 (en) 2009-01-08
EP1789086A4 (en) 2009-01-14
WO2006023651A3 (en) 2006-09-21
WO2006023649A2 (en) 2006-03-02
JP2015052022A (ja) 2015-03-19
JP2012067139A (ja) 2012-04-05
WO2006036371A2 (en) 2006-04-06
JP2008510714A (ja) 2008-04-10
WO2006036371A3 (en) 2006-12-21
WO2006023629A2 (en) 2006-03-02
EP2783701A3 (en) 2014-12-17
JP2012036225A (ja) 2012-02-23
US20150030590A1 (en) 2015-01-29
WO2006023649A3 (en) 2006-06-22
US20080260728A1 (en) 2008-10-23
AU2005277343A1 (en) 2006-03-02
US20120276048A1 (en) 2012-11-01
WO2006023629A3 (en) 2006-09-28
EP2783701A2 (en) 2014-10-01

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