DK1858926T3 - Opløselige glycosaminoglycanaser og fremgangsmåder til at fremstille og anvende opløselige glycosaminoglycanaser - Google Patents

Opløselige glycosaminoglycanaser og fremgangsmåder til at fremstille og anvende opløselige glycosaminoglycanaser Download PDF

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DK1858926T3
DK1858926T3 DK06736105.5T DK06736105T DK1858926T3 DK 1858926 T3 DK1858926 T3 DK 1858926T3 DK 06736105 T DK06736105 T DK 06736105T DK 1858926 T3 DK1858926 T3 DK 1858926T3
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agent
shasegp
hyaluronidase
pharmaceutical composition
polypeptide
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DK06736105.5T
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Louis H Bookbinder
Anirban Kundu
Gregory I Frost
Michael F Haller
Gilbert A Keller
Tyler M Dylan
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Halozyme Inc
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Priority claimed from US11/065,716 external-priority patent/US7871607B2/en
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Claims (23)

1. Farmaceutisk sammensætning, omfattende et PEGyleret opløseligt humant hyaluronidase glycoprotein i en farmaceutisk bærer, hvori: den farmaceutiske sammensætning er formuleret til anvendelse i intravenøs administration; hyaluronidasen indeholder tre til seks PEG-enheder per polypeptid; hyaluronidasen er neutral-aktiv; hyaluronidasen er opløselig; and hyaluronidasen er et glycoprotein indeholdende mindst en N-bundet sukkerenhed, hvori den N-bundne sukkerenhed er kovalent fastgjort til en asparaginenhed i polypeptidet.
2. Farmaceutisk sammensætning ifølge krav 1, hvori hyaluronidasen omfatter en aminosyresekvens, der udviser mindst 95% sekvensidentitet med SEQ ID NO:1 eller SEQ ID NO:3, med det forbehold, at polypeptidet ikke består af aminosyresekvensen fremvist i SEQ ID NO:1.
3. Farmaceutisk sammensætning ifølge krav 1 eller krav 2, hvori hyaluronidasen omfatter en aminosyresekvens, der som minimum omfatter aminosyresekvensen fremvist som aminosyreenheder 36-464 i SEQ ID NO: 1, med det forbehold, at polypeptidet ikke består af aminosyresekvensen fremvist i SEQ ID NO: 1.
4. Farmaceutisk sammensætning ifølge ethvert af kravene 1-3, hvori hyaluronidasen består af aminosyresekvensen fremvist som aminosyrer 1-483 i SEQ ID NO: 1, eller en aminosyresekvens, der udviser mindst 95% sekvensidentitet med aminosyrer 36-483 i SEQ ID NO: 1.
5. Farmaceutisk sammensætning ifølge ethvert af kravene 1-4, hvori hyaluronidasen omfatter en C-terminal aminosyreenhed, der er valgt blandt aminosyreenheder 477, 478, 479, 480, 481 og 482 i sekvensen af aminosyreenheder fremvist i SEQ ID NO:1.
6. Farmaceutisk sammensætning ifølge ethvert af kravene 1-5, hvori hyaluronidasen kodes af et nucleinsyremolekyle med en sekvens af nucleotider fremvist som nucleotider 106-1446 i SEQ ID NO:6, eller en del deraf, der koder for et katalytisk aktivt polypeptid.
7. Farmaceutisk sammensætning ifølge krav 6, hvori hyaluronidasen omfatter rekombinant humant PH20 (rHUPH20), der udtrykkes i og udskilles af CHO-celler.
8. Farmaceutisk sammensætning ifølge ethvert af kravene 1-7, hvori nævnte PEG-enheder er forgrenede.
9. Farmaceutisk sammensætning ifølge ethvert af kravene 1-8, hvori nævnte PEG-enheder er et resultat af reaktionen med et PEG-reagens valgt blandt mPEG-SBA (5kDa), mPEG-SBA (20kDa), mPEG-SBA 30kDa), mPEG-SMB (20kDa) mPEG-SMB (30kDa), mPEG-butyraldehyd (30kDa), mPEG-SPA (20kDa), mPEG-SPA (30kDa), mPEG2-NHS (10kDa forgrenet), mPEG2-NHS (20kDa forgrenet), mPEG-NHS (40kDa forgrenet), mPEG2-NHS (60kDa forgrenet), PEG-NHS-biotin (5kDa biotinyleret), PEG-p-nitrophenyl-carbonat (30kDa) og PEG-propionaldehyd (30kDa).
10. Farmaceutisk sammensætning ifølge ethvert af kravene 1-9 til anvendelse til at øge leveringen eller diffusionen af et farmakologisk middel til et individ.
11. Farmaceutisk sammensætning ifølge krav 10, hvori midlet vælges blandt et kemotherapeutisk middel, et smertestillende middel, et anti-inflammatorisk middel, et antimicrobielt middel, et amøbicidt middel, et middel mod trichomononas, et anti-parkinson middel, et anti-malaria middel, et krampebekæmpende middel, et anti-depressivt middel, et antiarthritisk middel, et antisvampe middel, et antihypertensiv middel, et febernedsættende middel, et middel mod parasitter, et antihistaminmiddel, et alpha- adrenergt agonistmiddel, et alpha-blokker middel, et anæstesimiddel, et bronchieudvidende middel, et biocidmiddel, et bactericidmiddel, et bakteriostatisk middel, et beta-adrenergt blokkermiddel, et calciumkanal blokkermiddel, et kardiovasculært medikamentmiddel, et svangerskabsforebyggende middel, et middel mod kongestion, et vanddrivende middel, et beroligende middel, et diagnostisk middel, et elektrolytmiddel, et sovemiddel, et hormonmiddel, et middel mod hyperglycæmi, et muskelafslappende middel, et muskelsammetrækkende middel, et øjenmiddel, et parasympatikomimetisk middel, et psykotonikum middel, et sederende middel, en søvnfremmer, et sympatikomimetisk middel, et middel mod dårlige nerver, et urinvejsmiddel, et vaginalt middel, et virusdræbende middel, et vitaminmiddel, et ikke-steroidt anti-inflammatorisk middel, et angiotensin-konverterende enzyminhibitormiddel, et polypeptid, et protein, en nucleinsyre, et medikament, og et organiske molekyle.
12. Farmaceutisk sammensætning ifølge krav 10, hvori midlet vælges blandt et detekterbart molekyle eller andet diagnostisk middel, eller et farmakologisk eller farmaceutisk effektivt middel.
13. Farmaceutisk sammensætning ifølge krav 10, hvori midlet er et anti-cancer middel eller et middel mod smitte.
14. Farmaceutisk sammensætning ifølge krav 10, hvori midlet er et blod-modificerende farmakologisk middel.
15. Farmaceutisk sammensætning ifølge krav 10, hvori midlet er et molekyle eller macromolekylært kompleks på mellem 20 nm og 200 nm i diameter.
16. Farmaceutisk sammensætning ifølge krav 10, hvori midlet vælges blandt et Adalimumab, Agalsidase Beta, Aldesleukin, Alefacept, Ampicillin, Anakinra, Antipoliomyelitisk Vaccine, Anti-Thymocyt, Azithromycin, Becaplermin, Caspofungin, Cefazolin, Cefepim, Cefotetan, Ceftazidim, Ceftriaxon, Cetuximab, Cilastatin, Clavulansyre, Clindamycin, Darbepoetin Alfa, Deaclizumab, Diphtheritoxoid, Efalizumab, Epinephrin, Erythropoietin Alpha, Etanercept, Filgrastim, Fluconazol, Follikelstimulerende hormoner, såsom Follitropin Alpha og Follitropin Beta, Fosphenytoin, Fluconazol, Gadodiamid, Gadopentetat, Gatifloxacin, Glatiramer, GM- CSF, Goserelin, Granisetron, Haemophilus Influenza B, Haloperidol, Hepatitis A Vaccine, Hepatitis B Vaccine, Ibritumomab Tiuxetan, Immunoglobulin, Influenza Virus Vaccine, Infliximab, Insulin, Insulin Glargine, Interferon Alfa-2a, Interferon Alfa-2b, Interferon Alfacon-1, Interferon Alfa-n3, Interferon Beta, Interferon Beta- la, Interferon Gamma, lodixanol, lohexol, lopamidol, loversol, Ketorolac, Laronidase, Levofloxacin, Lidocain, Linezolid, Lorazepam, Mæslingevaccine, Vaccine mod Mæslinge-Fåresyge-Røde-hundevirus, Medroxyprogesteron, Meropenem, Methylprednisolon, Midazolam, Morfin, Octreotid, Omalizumab, Ondansetron, Palivizumab, Pantoprazol, Pegaspargase, Pegfilgrastim, Peg-Interferon Alfa-2a, Peg-Interferon Alfa-2b, Pegvisomant, Stivkrampevaccine, Piperacillin, Pneumococvaccine og Pneumocockonjugatvaccine, Promethazin, Reteplase, Somatropin, Sulbactam, Sumatriptan, Tazobactam, Tenecteplase, Tetanus Purified Toxoid, Ticarcillin, Tositumomab, Triamcinolone Acetonide, Vancomycin, og Skoldkoppevaccine.
17. Farmaceutisk sammensætning ifølge krav 10, hvori midlet er et antibiotisk middel eller kombination af midler valgt blandt Aminoglycosider; Amphenicoler; Ansamyciner; Carbacephemer; Carbapenemer; Cephalosporiner eller Cephemer; Cephamyciner; Clavamer; Cykliske lipopeptider; Diaminopyrimidiner; Ketolider; Lincosamider; Macrolider; Monobactamer; Nitrofuraner; Oxacephemer; Oxazolidinoner; Penemer, thienamyciner og forskellige beta-lactamer; Penicilliner; Antibiotiske polypeptider; Quinoloner; Sulfonamider; Sulfoner; Tetracycliner; og andre antibiotika (såsom Clofoctoler, Fusidinsyre, Hexediner, Methenaminer, Nitrofurantoiner, Nitroxoliner, Ritipenemer, Taurolidiner, Xibomoler).
18. Farmaceutisk sammensætning ifølge krav 10, hvori midlet et et middel mod cancer eller kombination af midler valgt blandt Aclacinomyciner, Actinomyciner, Adriamyciner, Ancitabineer, Anthramyciner, Azacitidiner, Azaseriner, 6-Azauridiner, Bisantrener, Bleomyciner, Cactinomyciner, Carmofurer, Carmustiner, Carubiciner, Carzinophiliner, Chromomyciner, Cisplatiner, Cladribiner, Cytarabiner, Dactinomyciner, Daunorubiciner, Denopteriner, 6-Diazo-5-Oxo-L-Norleuciner, Doxifluridiner, Doxorubiciner, Edatrexater, Emitefurser, Enocitabineer, Fepirubiciner, Fludarabiner, Fluorouraciler, Gemcitabiner, Idarubicins, Loxuridines, Menogarils, 6-Mercaptopurines, Methotrexates, Mithramycins, Mitomyciner, Mycophenolsyrer, Nogalamyciner, Olivomyciner, Peplomyciner, Pirarubiciner, Piritreximer, Plicamyciner, Porfiromyciner, Pteropteriner, Puromyciner, Retinoidsyrer, Streptonigriner, Streptozociner, Tagafurer, Tamoxifener, Thiamipriner, Thioguaniner, Triamcinoloner, Trimetrexater, Tubercidiner, Vinblastiner, Vineristiner, Zinostatiner, og Zorubiciner.
19. Farmaceutisk sammensætning ifølge ethvert af kravene 1-9 til anvendelse i behandling af cancer.
20. Farmaceutisk sammensætning til anvendelse ifølge krav 19, hvori canceren er en invasiv tumor.
21. Farmaceutisk sammensætning ifølge ethvert af kravene 1-9 til anvendelse i behandling af en forstyrrelse i pattedyrets øje ved at inducere fortætning i glaslegemet; til anvendelse i behandling af forstyrrelser involverende et overskud af glycosaminoglycaner ved fjernelse af glycosaminoglycaner; eller til anvendelse i behandling af et pattedyr, som har haft et slagtilfælde eller anden CNS skade ved at lindre konsekvenserne af slagtilfældet eller anden CNS skade.
22. Farmaceutisk sammensætning ifølge krav 10, hvori midlet et et antistof.
23. Farmaceutisk sammensætning ifølge krav 10, hvori midlet er monoklonalt antistof.
DK06736105.5T 2005-02-23 2006-02-23 Opløselige glycosaminoglycanaser og fremgangsmåder til at fremstille og anvende opløselige glycosaminoglycanaser DK1858926T3 (da)

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