WO2006023651A2 - Extended treatment of multiple sclerosis - Google Patents
Extended treatment of multiple sclerosis Download PDFInfo
- 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
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—Immunoglobulins [IGs], 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 [IGs], 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)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Endocrinology (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Preliminary Treatment Of Fibers (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Heat Treatment Of Articles (AREA)
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2005277343A AU2005277343B2 (en) | 2004-08-20 | 2005-08-18 | Extended treatment of multiple sclerosis |
| US11/573,823 US20090010926A1 (en) | 2004-08-20 | 2005-08-18 | Extended Treatment of Multiple Sclerosis |
| CA002577188A CA2577188A1 (en) | 2004-08-20 | 2005-08-18 | Extended treatment of multiple sclerosis |
| JP2007528011A JP2008510714A (ja) | 2004-08-20 | 2005-08-18 | 多発性硬化症の長期処置 |
| EP05804218A EP1789086A4 (en) | 2004-08-20 | 2005-08-18 | PROLONGED 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 |
|---|---|---|---|
| US60347004P | 2004-08-20 | 2004-08-20 | |
| US60349504P | 2004-08-20 | 2004-08-20 | |
| US60346804P | 2004-08-20 | 2004-08-20 | |
| US60/603,495 | 2004-08-20 | ||
| US60/603,468 | 2004-08-20 | ||
| US60/603,470 | 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 (enExample) |
| EP (2) | EP1789086A4 (enExample) |
| JP (4) | JP2008510714A (enExample) |
| AU (1) | AU2005277343B2 (enExample) |
| CA (2) | CA2478458A1 (enExample) |
| WO (4) | WO2006023651A2 (enExample) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9326947B1 (en) | 2014-02-28 | 2016-05-03 | Banner Life Sciences Llc | Controlled release fumarate esters |
| 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 |
Families Citing this family (33)
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| EP1833509A4 (en) * | 2004-12-03 | 2008-12-03 | Biogen Idec Inc | DELAYING OR PREVENTING THE APPEARANCE OF MULTIPLE SCLEROSIS |
| EP1882338B1 (en) | 2005-05-12 | 2011-09-21 | Koninklijke Philips Electronics N.V. | Distributed learning method for wireless mesh networks |
| LT2676967T (lt) | 2006-02-28 | 2019-09-10 | Biogen Ma Inc. | Uždegiminių ir autoimuninių ligų gydymo būdai su natalizumabu |
| BRPI0708392A2 (pt) * | 2006-03-03 | 2011-05-24 | Elan Pharm Inc | métodos de tratamento de um paciente com uma doença inflamatória ou autoimune com natalizumab e de uso de natalizumab para tratar um paciente com uma doença inflamatória ou autoimune |
| WO2008103378A2 (en) * | 2007-02-20 | 2008-08-28 | Merrimack Pharmaceuticals, Inc. | Methods of treating multiple sclerosis by administration of alpha-fetoprotein in combination with an integrin antagonist |
| BRPI0814252B8 (pt) | 2007-06-14 | 2021-05-25 | Biogen Idec Inc | composição farmacêutica aquosa estável compreendendo natalizumabe, dose unitária, e seringa pré-cheia |
| US11287423B2 (en) | 2010-01-11 | 2022-03-29 | Biogen Ma Inc. | Assay for JC virus antibodies |
| EP4524571A3 (en) | 2010-01-11 | 2025-06-11 | Biogen MA Inc. | Assay for jc virus antibodies |
| EP4032912B1 (en) | 2010-04-16 | 2025-05-28 | Biogen MA Inc. | Anti-vla-4 antibodies |
| US8822663B2 (en) | 2010-08-06 | 2014-09-02 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
| CA2821992A1 (en) | 2010-10-01 | 2012-04-05 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
| DE12722942T1 (de) | 2011-03-31 | 2021-09-30 | Modernatx, Inc. | Freisetzung und formulierung von manipulierten nukleinsäuren |
| SG195049A1 (en) * | 2011-05-26 | 2013-12-30 | Biogen Idec Inc | Methods of treating multiple sclerosis and preserving and/or increasing myelin content |
| KR102473834B1 (ko) | 2011-05-31 | 2022-12-02 | 바이오젠 엠에이 인코포레이티드 | Pml의 위험을 판단하는 방법 |
| US9464124B2 (en) | 2011-09-12 | 2016-10-11 | Moderna Therapeutics, Inc. | Engineered nucleic acids and methods of use thereof |
| HRP20220250T1 (hr) | 2011-10-03 | 2022-04-29 | Modernatx, Inc. | Modificirani nukleozidi, nukleotidi i nukleinske kiseline, te njihove uporabe |
| SI2791160T1 (sl) | 2011-12-16 | 2022-07-29 | Modernatx, Inc. | Sestave modificirane MRNA |
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| AU2013243952A1 (en) | 2012-04-02 | 2014-10-30 | Modernatx, Inc. | Modified polynucleotides for the production of cytoplasmic and cytoskeletal proteins |
| US9572897B2 (en) | 2012-04-02 | 2017-02-21 | Modernatx, Inc. | Modified polynucleotides for the production of cytoplasmic and cytoskeletal proteins |
| US9283287B2 (en) | 2012-04-02 | 2016-03-15 | Moderna Therapeutics, Inc. | Modified polynucleotides for the production of nuclear proteins |
| US10501512B2 (en) | 2012-04-02 | 2019-12-10 | Modernatx, Inc. | Modified polynucleotides |
| SMT202200337T1 (it) | 2012-11-26 | 2022-09-14 | Modernatx Inc | Rna modificato al livello del terminale |
| US8980864B2 (en) | 2013-03-15 | 2015-03-17 | Moderna Therapeutics, Inc. | Compositions and methods of altering cholesterol levels |
| HK1216546A1 (zh) | 2013-05-28 | 2016-11-18 | Biogen Ma Inc. | 评估pml风险的方法 |
| US10023626B2 (en) | 2013-09-30 | 2018-07-17 | Modernatx, Inc. | Polynucleotides encoding immune modulating polypeptides |
| US10323076B2 (en) | 2013-10-03 | 2019-06-18 | Modernatx, Inc. | Polynucleotides encoding low density lipoprotein receptor |
| MA41785A (fr) | 2015-03-20 | 2018-01-23 | Biogen Ma Inc | Procédés et compositions pour l'administration intraveineuse de fumarates pour le traitement de maladies neurologiques |
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| US12370233B2 (en) | 2016-08-31 | 2025-07-29 | Mapi Pharma Ltd. | Depot systems comprising glatiramer acetate |
| WO2018178973A1 (en) | 2017-03-26 | 2018-10-04 | Mapi Pharma Ltd. | Glatiramer depot systems for treating progressive forms of multiple sclerosis |
| CN119080931A (zh) | 2018-06-04 | 2024-12-06 | 马萨诸塞州渤健公司 | 具有降低的效应功能的抗vla-4抗体 |
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- 2005-08-18 EP EP05804218A patent/EP1789086A4/en not_active Ceased
- 2005-08-18 JP JP2007528011A patent/JP2008510714A/ja not_active Withdrawn
- 2005-08-18 US US11/573,817 patent/US20080260728A1/en not_active Abandoned
- 2005-08-18 WO PCT/US2005/029403 patent/WO2006023649A2/en not_active Ceased
- 2005-08-18 EP EP14165153.9A patent/EP2783701A3/en not_active Withdrawn
- 2005-08-18 AU AU2005277343A patent/AU2005277343B2/en not_active Expired
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2012
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2014
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- 2014-12-15 JP JP2014252699A patent/JP2015052022A/ja active Pending
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| 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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Also Published As
| Publication number | Publication date |
|---|---|
| AU2005277343B2 (en) | 2011-07-07 |
| WO2006036371A2 (en) | 2006-04-06 |
| JP2015052022A (ja) | 2015-03-19 |
| EP2783701A2 (en) | 2014-10-01 |
| EP1789086A4 (en) | 2009-01-14 |
| WO2006023649A2 (en) | 2006-03-02 |
| WO2006023651A3 (en) | 2006-09-21 |
| EP2783701A3 (en) | 2014-12-17 |
| US20080260728A1 (en) | 2008-10-23 |
| JP2008510714A (ja) | 2008-04-10 |
| US20150175703A1 (en) | 2015-06-25 |
| JP2012036225A (ja) | 2012-02-23 |
| WO2006023629A3 (en) | 2006-09-28 |
| CA2478458A1 (en) | 2006-02-20 |
| US20120276048A1 (en) | 2012-11-01 |
| AU2005277343A1 (en) | 2006-03-02 |
| US20150030590A1 (en) | 2015-01-29 |
| EP1789086A2 (en) | 2007-05-30 |
| US20090010926A1 (en) | 2009-01-08 |
| JP2012067139A (ja) | 2012-04-05 |
| WO2006023629A2 (en) | 2006-03-02 |
| WO2006036371A3 (en) | 2006-12-21 |
| WO2006023649A3 (en) | 2006-06-22 |
| CA2577188A1 (en) | 2006-03-02 |
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