DK1993673T3 - Injicerbar kombinationsterapi til øjensygdomme - Google Patents

Injicerbar kombinationsterapi til øjensygdomme Download PDF

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Publication number
DK1993673T3
DK1993673T3 DK07718112.1T DK07718112T DK1993673T3 DK 1993673 T3 DK1993673 T3 DK 1993673T3 DK 07718112 T DK07718112 T DK 07718112T DK 1993673 T3 DK1993673 T3 DK 1993673T3
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therapeutic agent
eye
compstatin
trp
therapeutic
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DK07718112.1T
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Pascal Deschatelets
Cedric Francois
Paul Olson
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Apellis Pharmaceuticals Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/08—Linear peptides containing only normal peptide links having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
    • A61K49/0008—Screening agents using (non-human) animal models or transgenic animal models or chimeric hosts, e.g. Alzheimer disease animal model, transgenic model for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6872—Intracellular protein regulatory factors and their receptors, e.g. including ion channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4703—Regulators; Modulating activity
    • G01N2333/4704—Inhibitors; Supressors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2500/00—Screening for compounds of potential therapeutic value
    • G01N2500/04—Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2500/00—Screening for compounds of potential therapeutic value
    • G01N2500/20—Screening for compounds of potential therapeutic value cell-free systems

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
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  • Microbiology (AREA)
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  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Rheumatology (AREA)
  • Mycology (AREA)
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Claims (15)

1. Første og andet terapeutiske midler til anvendelse til behandling af en øjensygdom karakteriseret ved makuladegeneration, choroidal neovaskularisering eller retinal neovaskularisering, hvor effektive mængder af de første og andet terapeutiske midler er administreret til individets øje, eventuelt i en enkelt procedure; det første terapeutiske middel er et anti-VEGF-middel udvalgt blandt gruppen bestående af antistoffer eller antistoffragmenter som binder til VEGF, et fusionsprotein indeholdende ekstracellulære domæner af to VEGF-receptorer forbundet til Fc-regionen af et antistof, og nukleinsyrer som binder til VEGF; og det andet terapeutiske middel er udvalgt blandt gruppen bestående af en compsta-tinanalog havende mindst 5 gange højere komplementinhiberende aktivitet end comp-statin, et monoklonalt antistof eller monoklonalt antistoffragment som binder til C3 og et antistof eller antistoffragment som binder til C5, faktor B eller faktor D.
2. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor compsta-tinanalogcn cr a) en forbindelse som omfatter et cyklisk peptid havende en kernesekvens af X’aa-Gln - Asp - Xaa - Gly (SEQ ID NO: 3), hvor X'aa og Xaa er udvalgt blandt Trp og analoger af Tip eller b) en forbindelse som omfatter et cyklisk peptid havende en kernesekvens af X'aa-Gln - Asp - Xaa - Gly-X"aa (SEQ ID NO: 4), hvor X'aa og Xaa hver er uafhængigt udvalgt blandt Trp og analoger af Trp og X"aa er udvalgt blandt His, Ala, uforgrenede aminosyrer med en methylgruppe, Phe, Trp og analoger af Trp eller c) en forbindelse som omfatter et cyklisk peptid havende en sekvens af X’aa 1 - X'aa2 - X'aa3 - X'aa4-Gln-Asp-Xaa-Gly- X"aal- X"aa2- X"aa3- X"aa4-X"aa5 (SEQ ID NO: 5), hvor X'aa4 og Xaa er udvalgt blandt Trp og analoger af Trp, hvor X'aal, X'aa2, X'aa3, X”aal, X"aa2, X"aa3, X"aa4 og X"aa5 er uafhængigt udvalgt blandt aminosyrer og aminosyreanaloger, og peplidet cy-cliseres via en binding mellem X'aa2 og X"aa4.
3. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor fremgangsmåden er en injektionsproeedure, såsom en injektionsprocedure, hvori det første og det andet terapeutiske middel injiceres i glaslegemet af individets øje og/eller en injektionsprocedure, hvori inden administrationen, det første terapeutiske middel er indeholdt i en sprøjte og det andet terapeutiske middel er indeholdt i en nål fastgjort til sprøjten og hvori det første terapeutiske middel foretrukket er opløst i et flydende medium placeret i sprøjten, og det andet terapeutiske middel omfatter et okulært implantat placeret i nålen.
4. Første og andet terapeutiske midler til anvendelse ifølge et hvilket som helst af de foregående krav, hvor det første terapeutiske middel eller komposition er udvalgt blandt gruppen bestående af bevacizumab, ranibizumab, pegaptanib og VEGF-Trap.
5. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor det første terapeutiske middel eller komposition er opløst eller suspenderet i et flydende medium inden administration og/eller det andet terapeutiske middel omfatter et okulært implantat, hvor eventuelt det andet terapeutiske middel er frigivet fra det okulære implantat for at opretholde et terapeutisk niveau i individets øje over en periode på mindst tre måneder.
6. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor det andet terapeutiske middel er administreret som en formulering med forsinket frigivelse, som omfatter et polymer materiale, såsom polymer materiale udvalgt blandt gruppen bestående af: poly-mælkesyre (FLA), polyglycolsyre (PGA), poly-lactid-co-glycolid (PLGA)5 poly(phosphazin), poly (phosphatester), polycaprolactoner, polyanhydrider, ethylenvinylacetat, polyorthoestere, polvethere, poly (betaaminoestere), copolymerer indeholdende monomere underenheder, fundet i en hvilken som helst af de foregående polymerer, kollagen, albumin, chitosan, alginat, hyaluronsyre og blandinger af en hvilken som helst af de foregående polymerer og foretrukket det polymere materiale er biologisk nedbrydeligt,
7. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor det andet terapeutiske middel er administreret som en formulering med forsinket frigivelse, som omfatter nanopartikier, mikropartikler, dendrimerer eller liposomer omfattende det andet terapeutiske middel, et fast eller halvfast materiale der indfanger eller indkapsler det andet terapeutiske middel eller et inaktivt materiale hvortil det andet terapeutiske middel er ko valent bundet.
8. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor det første terapeutiske middel er administreret i opløselig- eller partikel-form i et flydende medium og det andet terapeutiske middel er administreret i eller bundet til en fast eller halvfast matrix og/eller hvor det andet terapeutiske middel, når administreret som en komponent af en formulering med forsinket frigivelse, har en aktivitetsperiode der er længere end den for det første terapeutiske middel.
9. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor administration af det andet terapeutiske middel forlænger tidsintervallet, i hvilket individet oplever forbedring i tilstanden af individets øje i forhold til det tidsinterval, i hvilket individet ville have oplevet forbedring, hvis det første terapeutiske middel var blevet administreret som eneste terapi.
10. Første og andet terapeutiske midler til anvendelse ifølge et hvilket som helst af de foregående krav, hvor øjensygdommen er exsudativ aldersrelateret makuladegeneration.
11. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor individet har oplevet en mærkbar forringelse af tilstanden af individets øje indenfor de to uger forud for administration af de første og andet terapeutiske midler,
12. Første og andet terapeutiske midler til anvendelse ifølge krav 1, hvor fremgangsmåden er udført en eller flere yderligere gange med tidsintervaller længere end aktivi-tetsperioden for det første terapeutiske middel.
13. Genstand omfattende de første og andet terapeutiske midler ifølge krav 1, hvor genstanden omfatter en nål indeholdende det andet terapeutiske middel, hvor genstanden eventuelt yderligere omfatter en sprøjte, såsom en sprøjte som indeholder det første terapeutiske middel og/eller hvor genstanden indeholder en enhedsdoseringsform af det første terapeutiske middel og/eller en enhedsdoseringsform af det andet terapeu- tiske middel.
14. Genstand ifølge krav 13, yderligere omfattende en sprøjte, hvor genstanden indeholder mindst et afsnit, og sprøjten og nålen er anbragt i et enkelt afsnit af genstanden og/eller hvor sprøjten og nålen er fastgjort til hinanden eller hvor genstanden indeholder mindst to afsnit, og hvor sprøjten og nålen er anbragt i individuelle afsnit.
15. Genstand omfattende de første og andet terapeutiske midler ifølge krav l, hvor hvert terapeutisk middel er indeholdt i en individuel sprøjte og hvor genstanden eventuelt yderligere omfatter en nål.
DK07718112.1T 2006-01-19 2007-01-19 Injicerbar kombinationsterapi til øjensygdomme DK1993673T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US76097406P 2006-01-19 2006-01-19
US11/544,389 US8168584B2 (en) 2005-10-08 2006-10-06 Methods of treating age-related macular degeneration by compstatin and analogs thereof
PCT/US2007/001649 WO2007084765A2 (en) 2006-01-19 2007-01-19 Injectable combination therapy for eye disorders

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DK1993673T3 true DK1993673T3 (da) 2017-10-16

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US (6) US8168584B2 (da)
EP (1) EP1993673B1 (da)
JP (3) JP2009523821A (da)
AU (2) AU2007207385B2 (da)
DK (1) DK1993673T3 (da)
ES (1) ES2644752T3 (da)
PL (1) PL1993673T3 (da)
WO (1) WO2007084765A2 (da)

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