DK2595624T3 - Fremgangsmåder til behandling eller forebyggelse af negative bivirkninger forbundet med administration af et anti-hyaluronanmiddel - Google Patents

Fremgangsmåder til behandling eller forebyggelse af negative bivirkninger forbundet med administration af et anti-hyaluronanmiddel Download PDF

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DK2595624T3
DK2595624T3 DK11735755.8T DK11735755T DK2595624T3 DK 2595624 T3 DK2595624 T3 DK 2595624T3 DK 11735755 T DK11735755 T DK 11735755T DK 2595624 T3 DK2595624 T3 DK 2595624T3
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hyaluronan
hyaluronidase
seq
polypeptide
degrading enzyme
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Harold Michael Shepard
Curtis Thompson
Xiaoming Li
Gregory Ian Frost
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Halozyme Inc
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    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase

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Claims (20)

1. Anvendelse af et glucocorticoid til formulering af et medikament til modvirkning af en negativ bivirkning associeret med behandling med et hyaluronan-nedbrydende enzym, hvori det hyaluronan-nedbrydende enzym er konjugeret til en polymer.
2. Farmaceutisk sammensætning omfattende et glucocorticoid til anvendelse til modvirkning af en negativ bivirkning associeret med behandling med et hyaluronan-nedbrydende enzym, hvori det hyaluronan-nedbrydende enzym er konjugeret til en polymer.
3. Anvendelse ifølge krav 1 eller en farmaceutisk sammensætning til anvendelse ifølge krav 2, hvori den negative virkning er en bivirkning i bevægeapparatet.
4. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-3, hvori den negative virkning er i bevægeapparatet og er valgt blandt muskel- og ledsmerter, stivhed i øvre ekstremiteter, stivhed i nedre ekstremiteter, kramper, myositis, muskelømhed og ømhed over hele kroppen, svaghed, træthed og et nedsat bevægelsesomfang ved knæ- og albueled.
5. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-4, hvori glucocorticoidet er valgt blandt kortisoner, dexamethasoner, hydrokortisoner, methylprednisoloner, prednisoloner og prednisoner.
6. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-5, hvori glucocorticoidet er formuleret til oral administration.
7. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-6, hvori glucocorticoidet er formuleret til administration af en enkelt dosis i en mængde i et interval mellem eller omkring mellem 0,1 til 20 mg.
8. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-7, hvori polymeren er PEG og det hyaluronan-nedbrydende enzym er PEGyleret.
9. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 1-8, hvori det hyaluronan-nedbrydende enzym er en hyaluronidase.
10. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge krav 9, hvori hyaluronidasen er en PH20 eller en opløselig PH20.
11. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge krav 10, hvori hyaluronidasen er en opløselig PH20, som er blevet afkortet for at fjerne et C-terminal glycosylphospatidylinositol (GPI) bindingssted eller en del af GPI bindingsstedet.
12. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge ethvert af kravene 9-11, hvori hyaluronidasen er neutral aktiv og N-glycosyleret og valgt fra: (a) et hyaluronidasepolypeptid, der er PH20 i fuld længde, eller er en afkortet C-terminal af PH20, hvori PH20 i fuld længde omfatter sekvensen af aminosyrer anført i SEQ ID NO: 2, eller (b) et hyaluronidasepolypeptid, der omfatter en sekvens af aminosyrer, der har mindst 85% sekvensidentitet med polypeptidet eller den afkortede form af sekvensen af aminosyrer anført i SEQ ID NO: 2, eller (c) et hyaluronidasepolypeptid af (a) eller (b), der omfatter aminosyresubstitutioner, hvorved hyaluronidasepolypeptidet har en sekvens af aminosyrer, der har mindst 85% sekvensidentitet med polypeptidet anført i SEQ ID NO: 2 eller med den tilsvarende afkortede form deraf.
13. Anvendelsen eller den farmaceutiske sammensætning til anvendelse ifølge krav 12, hvori den afkortede form indeholder aminosyrer 36 til 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482 eller 483 i SEQ ID NO: 1.
14. Kombination, omfattende: en første sammensætning omfattende et hyaluronan-nedbrydende enzym formuleret til intravenøs administration, hvori det hyaluronan-nedbrydende enzym er konjugeret til en polymer; og en anden sammensætning omfattende et glucocorticoid.
15. Kombination ifølge krav 14, hvorved glucocorticoidet er valgt blandt kortisoner, dexamethasoner, hydrokortisoner, methylprednisoloner, prednisoloner og prednisoner.
16. Kombination ifølge krav 14 eller krav 15, hvorved det hyaluronan-nedbrydende enzym er en hyaluronidase.
17. Kombination ifølge krav 16, hvorved hyaluronidasen er en PH20 eller en opløselig PH20.
18. Kombination ifølge krav 17, hvori hyaluronidasen er en opløselig PH20, som er blevet afkortet for at fjerne et C-terminal glycosylphospatidylinositol (GPI) bindingssted eller en del af GPI bindingsstedet.
19. Kombination ifølge ethvert af kravene 16-18, hvori hyaluronidasen er neutral aktiv og N-glycosyleret og valgt ud fra: (a) et hyaluronidasepolypeptid, der er PH20 i fuld længde eller er en afkortet C-terminal af PH20, hvori PH20 i fuld længde omfatter sekvensen af aminosyrer, anført i SEQ ID NO: 2, eller (b) et hyaluronidasepolypeptid, der omfatter en sekvens af aminosyrer, der har mindst 85% sekvensidentitet med polypeptidet eller den afkortede form af sekvensen af aminosyrer anført i SEQ ID NO: 2, eller (c) et hyaluronidasepolypeptid af (a) eller (b), der omfatter aminosyresubstitutioner, hvorved hyaluronidasepolypeptidet har en sekvens af aminosyrer, der har mindst 85% sekvensidentitet med polypeptidet anført i SEQ ID NO: 2 eller med de tilsvarende afkortede former deraf.
20. Kombination ifølge krav 19, hvorved den afkortede form indeholder aminosyrer 36 til 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482 eller 483 i SEQ ID NO: 1.
DK11735755.8T 2010-07-20 2011-07-15 Fremgangsmåder til behandling eller forebyggelse af negative bivirkninger forbundet med administration af et anti-hyaluronanmiddel DK2595624T3 (da)

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US45526010P 2010-10-14 2010-10-14
PCT/US2011/044281 WO2012012300A2 (en) 2010-07-20 2011-07-15 Adverse side-effects associated with administration of an anti-hyaluronan agent and methods for ameliorating or preventing the side-effects

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PL2477603T3 (pl) * 2009-09-17 2016-10-31 Trwały preparat złożony hialuronidazy i immunoglobuliny oraz sposoby jego stosowania
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