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HRP20211453T1 - Liječenje amd uporabom aav sflt-1 - Google Patents

Liječenje amd uporabom aav sflt-1 Download PDF

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Publication number
HRP20211453T1
HRP20211453T1 HRP20211453TT HRP20211453T HRP20211453T1 HR P20211453 T1 HRP20211453 T1 HR P20211453T1 HR P20211453T T HRP20211453T T HR P20211453TT HR P20211453 T HRP20211453 T HR P20211453T HR P20211453 T1 HRP20211453 T1 HR P20211453T1
Authority
HR
Croatia
Prior art keywords
raav
wet amd
treatment
vegf
administration
Prior art date
Application number
HRP20211453TT
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English (en)
Inventor
Ian J. Constable
Elizabeth P. Rakoczy
Chooi-may LAI
Thomas W. Chalberg Jr.
Original Assignee
Avalanche Australia Pty Ltd. c/o MPR Group Pty Ltd.
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 Avalanche Australia Pty Ltd. c/o MPR Group Pty Ltd. filed Critical Avalanche Australia Pty Ltd. c/o MPR Group Pty Ltd.
Publication of HRP20211453T1 publication Critical patent/HRP20211453T1/hr

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/02—Subjective types, i.e. testing apparatus requiring the active assistance of the patient
    • A61B3/028—Subjective types, i.e. testing apparatus requiring the active assistance of the patient for testing visual acuity; for determination of refraction, e.g. phoropters
    • A61B3/032—Devices for presenting test symbols or characters, e.g. test chart projectors
    • 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
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/76—Viruses; Subviral particles; Bacteriophages
    • A61K35/761—Adenovirus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
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    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • C—CHEMISTRY; METALLURGY
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    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
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    • A—HUMAN NECESSITIES
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    • C12N2710/14011—Baculoviridae
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Claims (8)

1. Rekombinantni adeno-asocirani virus (rAAV) za uporabu u postupku liječenja mokre senilne makularne degeneracije (mokra AMD) kod ljudskog subjekta koji boluje od mokre AMD, pri čemu postupak obuhvaća: i) davanje najmanje jedne doze inhibitora vaskularnog endotelnog faktora rasta (VEGF) odabranog od protu-VEGF protutijela i topljivog VEGF receptora, ili njihovog fuzijskog proteina ili fragmenta, intravitrealnom injekcijom, između 1 i 30 dana prije primjene rAAV ljudskom subjektu; ii) injeciranje, u oko ljudskog subjekta, jedinične doze koja sadrži najmanje 1 x 106, a najviše 1 x 1015 genoma rAAV vektora, i farmaceutski prihvatljiv nosač, pri čemu rAAV sadrži sekvencu nukleinske kiseline koja kodira anti-VEGF protein i pri čemu anti-VEGF protein sadrži ljudski sFLT1 ili njegov funkcionalni fragment; i po izboru iii) primjenu jedne ili dvije doze VEGF inhibitora i) intraokularnim injektiranjem u intervalu od 30 dana nakon primjene rAAV.
2. rAAV za uporabu u postupku liječenja mokreAMD sukladno patentnom zahtjevu 1, pri čemu se injeciranje vrši samo jednom u najmanje 18 meseci.
3. rAAV za uporabu u postupku liječenja mokreAMD sukladno patentnom zahtjevu 1 ili 2, pri čemu jedinična doza sadrži najmanje 1 x 108, a najviše 1 x 1013 genoma vektora.
4. rAAV za uporabu u postupku liječenja mokreAMD sukladno patentnom zahtjevu 1 ili 2, pri čemu jedinična doza sadrži najmanje 1 x 109, a najviše 3 x 1013 genoma vektora.
5. rAAV za uporabu u postupku liječenja mokreAMD sukladno bilo kojem od patentnih zahtjeva od 1 do 4, pri čemu uporaba nadalje obuhvaća mjerenje oštrine vida upotrebom slova Studije rane terapije u dijabetskoj retinopatiji (ETDRS), nakon primjene farmaceutskog pripravka, pri čemu se smanjenje neovaskularizacije zapaža fluoresceinskom angiografijom (FA) nakon primjene farmaceutskog pripravka, ili pri čemu se najbolje korigirana oštrina vida (BCVA) kod ljudskog subjekta smanjuje za manje od 15 slova, što se mjeri uporabom ETDRS slova nakon primjene farmaceutskog pripravka, ili pri čemu se BCVA kod ljudskog subjekta poboljšava za najmanje 1 red, što se mjeri uporabom ETDRS slova nakon primjene jedinične doze.
6. rAAV za uporabu u postupku liječenja mokreAMD sukladno bilo kojem od patentnih zahtjeva od 1 do 5, pri čemu injektiranje obuhvaća subretinalno injektiranje.
7. rAAV za uporabu u postupku liječenja mokreAMD sukladno patentnom zahtjevu 6, koji nadalje obuhvaća uklanjanje staklastog gela prije injektiranja jedinične doze.
8. rAAV za uporabu u postupku liječenja mokreAMD sukladno bilo kojem od patentnih zahtjeva od 1 do 7, pri čemu je VEGF-inhibitor i) odabran iz skupine koju čine bevacizumab, ranibizumab i aflibercept.
HRP20211453TT 2012-05-15 2013-05-07 Liječenje amd uporabom aav sflt-1 HRP20211453T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261647461P 2012-05-15 2012-05-15
US201261670535P 2012-07-11 2012-07-11
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