HRP20191010T1 - Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem - Google Patents

Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem Download PDF

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HRP20191010T1
HRP20191010T1 HRP20191010TT HRP20191010T HRP20191010T1 HR P20191010 T1 HRP20191010 T1 HR P20191010T1 HR P20191010T T HRP20191010T T HR P20191010TT HR P20191010 T HRP20191010 T HR P20191010T HR P20191010 T1 HRP20191010 T1 HR P20191010T1
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Croatia
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adm
adrenomedullin
acute
antibody against
fragment
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HRP20191010TT
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Andreas Bergmann
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Adrenomed Ag
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    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
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Claims (22)

1. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin, namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja radi sprječavanja ili smanjivanja disfunkcije organa ili sprječavanja insuficijencije organa kod navedenog pacijenta, naznačeni time što se navedeno protutijelo ili protutijelo fragment ili ne-Ig okosnica veže na područje od najmanje 4 aminokiselina u slijedu od aa 1-21 zrelog ljudskog ADM: YRQSMNNFQGLRSFGCRFGTC (SEQ ID NO: 23), što se navedeni organ bira iz skupine koju čine srce, bubreg, jetra, pluća, gušterača, tanko crijevo i slezena, te što se navedena kronična ili akutna bolest odnosno akutno stanje bira iz skupine koju čine teške infekcije, sindrom sistemnog upalnog odgovora (SIRS), sepsa, dijabetes, rak, akutne i kronične bolesti krvnih žila, poput primjerice srčane insuficijencije, infarkta miokarda, inzulta, ateroskleroze, šoka, poput primjerice septičnog šoka, i disfunkcija organa, disfunkcija jetre, opekline, kirurški zahvat, traume, otrovanje, oštećenja uzrokovana kemoterapijom.
2. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s patentnim zahtjevom 1, naznačeni time što su navedeno protutijelo ili protutijelo fragment ili ne-Ig okosnica monospecifični.
3. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačeni time što navedeno protutijelo ili fragment ili okosnica pokazuje afinitet vezanja na ADM od najmanje 10–7 M, naznačeni time što se navedeni afinitet vezanja određuje kao u Primjeru 1.
4. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeni time što navedeno protutijelo ili fragment ili okosnica nije ADM-vežući-Protein-1, komplementni čimbenik H.
5. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačeni time što navedeno protutijelo ili fragment ili okosnica prepoznaje i veže se na N-terminalni kraj, aa 1, zrelog adrenomedulina.
6. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačeni time što su navedeno protutijelo ili navedeni fragment ili navedena okosnica protutijelo ili fragment ili okosnica koje stabiliziraju ADM te mu produljuju poluvijek, t1/2 poluretencijsko vrijeme, adrenomedulina u serumu, krvi, plazmi najmanje 10%, po mogućnosti najmanje 50%, poželjnije > 50%, najpoželjnije > 100%.
7. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačeni time što navedeno protutijelo ili fragment ili okosnica blokira bioaktivnost ADM najviše 80%, po mogućnosti najviše 50%, prilikom određivanja bioaktivnosti ADM u funkcionalnom ispitivanju na cAMP na ljudskom rekombinantnom adrenomedulinskom receptoru kao u Primjeru 2.
8. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačeni time što navedeni pacijent boluje od bolesti koju se bira iz skupine koju čine sepsa, dijabetes, rak, srčana insuficijencija, te šok.
9. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačeni time što navedena bolest nije SIRS, sepsa ili septični šok.
10. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačeni time što je navedeno protutijelo ili fragment ljudsko monoklonsko protutijelo ili fragment koji se veže na ADM ili njegov fragment gdje teški lanac sadrži slijed kojeg se bira iz skupine koju čine: SEQ ID NO: 1 GYTFSRYW SEQ ID NO: 2 ILPGSGST SEQ ID NO: 3 TEGYEYDGFDY te gdje laki lanac sadrži sljedove SEQ ID NO: 4 QSIVISNGNTY SEQ ID NO: 5 RVS SEQ ID NO: 6 FQGSHIPYT.
11. Ljudsko monospecifično protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s patentnim zahtjevom 10, naznačeni time što navedeno protutijelo ili fragment sadrži slijed kojeg se bira iz skupine koju čine: SEQ ID NO: 7 (AM-VH-C) QVQLQQSGAELMKPGASVKISCKATGYTFSRYWIEWVKQRPGHGLEWIGEILP GSGSTNYNEKFKGKATITADTSSNTAYMQLSSLTSEDSAVYYCTEGYEYDGFD YWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLISLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKR VEPKHHHHHH SEQ ID NO: 8 (AM-VH1) QVQLVQSGAEVKKPGSSVKVSCKASGYTFSRYWISWVRQAPGQGLEWMGRIL PGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDGFD YWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLISLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKR VEPKHHHHHH SEQ ID NO: 9 (AM-VH2-E40) QVQLVQSGAEVKKPGSSVKVSCKASGYTFSRYWIEWVRQAPGQGLEWMGRIL PGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDGFD YWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLISLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKR VEPKHHHHHH SEQ ID NO: 10 (AM-VH3-T26-E55) QVQLVQSGAEVKKPGSSVKVSCKATGYTFSRYWISWVRQAPGQGLEWMGEIL PGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDGFD YWGQGTTVTVSSASTKGPSVFPLAPSSK8TSGGTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLISLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKR VEPKHHHHHH SEQ ID NO: 11 (AM-VH4-T26-E40-E55) QVQLVQSGAEVKKPGSSVKVSCKATGYTFSRYWIEWVRQAPGQGLEWMGEIL PGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDGFD YWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN SGALTSGVHTFPAVLQSSGLISLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKR VEPKHHHHHH SEQ ID NO: 12 (AM-VL-C) DVLLSQTPLSLPVSLGDQATISCRSSQSIVISNGNTYLEWYLQKPGQSPKLLIYR VSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDLGVYYCFQGSHIPYTFGGGTKLE IKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS QESVTEQDSKDSTISLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGE C SEQ ID NO: 13 (AM-VL1) DVVMTQSPLSLPVTLGQPASISCRSSQSIVISNGNTYLNWFQQRPGQSPRRLIYR VSNRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHIPYTFGQGTKL EIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGN SQESVTEQDSKDSTISLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRG EC SEQ ID NO: 14 (AM-VL2-E40) DVVMTQSPLSLPVTLGQPASISCRSSQSIVISNGNTYLEWFQQRPGQSPRRLIYRVSNRD SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHIPYTFGQGTKLEIKRTVAAPSV FIFPPSDEQLKSGTASWCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTIS LSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC.
12. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačeni time što je navedeno protutijelo ili fragment ili okosnica modulirajuće protutijelo ili fragment ili okosnica koji produljuju poluvijek, t1/2 poluretencijsko vrijeme, adrenomedulina u serumu, krvi, plazmi najmanje 10%, po mogućnosti najmanje 50%, poželjnije > 50%, najpoželjnije > 100%, te što blokiraju Bioaktivnost ADM najviše 80%, po mogućnosti najviše 50%, prilikom određivanja bioaktivnosti ADM u funkcionalnom ispitivanju na cAMP na ljudskom rekombinantnom adrenomedulinskom receptoru kao u Primjeru 2.
13. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačeni time što ih treba upotrijebiti u kombinaciji s vazopresorima, primjerice s katekolaminom i/ili s tekućinama koje se primijenjuje intravenski.
14. Protutijelo protiv adrenomedulina (ADM) ili fragment protutijela protiv ADM koje se veže na adrenomedulin ili ne-Ig okosnica protutijela protiv ADM koje se veže na adrenomedulin namijenjeni upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačeni time što ih treba upotrijebiti u kombinaciji s proteinom koji se veže na ADM i/ili dodatni aktivnim sastojcima.
15. Farmaceutska formulacija, naznačena time što sadrži protutijelo protiv ADM ili fragment protutijela protiv ADM ili ne-Ig okosnicu protutijela protiv ADM u skladu s bilo kojim od patentnih zahtjeva 1 do 14 namijenjen upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s bilo kojim od patentnih zahtjeva 1 do 14.
16. Farmaceutska formulacija namijenjena upotrebi u terapiji pacijenta koji boluje od kronične ili akutne bolesti ili akutnog stanja pacijenta u skladu s patentnim zahtjevom 15, naznačena time što je navedena farmaceutska formulacija otopina, po mogućnosti otopina spremna za upotrebu.
17. Farmaceutska formulacija namijenjena upotrebi u terapiji akutne bolesti ili akutnog stanja pacijenta koji boluje od kronične i/ili akutne bolesti ili akutnog stanja u skladu s patentnim zahtjevom 16, naznačeni time što je navedena farmaceutska formulacija u stanju osušenom smrzavanjem.
18. Farmaceutska formulacija namijenjena upotrebi u skladu s bilo kojim od patentnih zahtjeva 15 do 17, naznačena time što se navedenu farmaceutsku formulaciju primijenjuje intramuskularno.
19. Farmaceutska formulacija namijenjena upotrebi u skladu s bilo kojim od patentnih zahtjeva 15 do 17, naznačena time što se navedenu farmaceutsku formulaciju primijenjuje intravaskularno.
20. Farmaceutska formulacija namijenjena upotrebi u skladu s patentnih zahtjeva 15 do 17, naznačena time što se navedenu farmaceutsku formulaciju primijenjuje infuzijom.
21. Farmaceutska formulacija namijenjena upotrebi u skladu s patentnih zahtjeva 15 do 17, naznačena time što navedenu farmaceutsku formulaciju treba primijeniti sistemno na pacijentu radi sprječavanja ili smanjivanja disfunkcije organa ili insuficijencije organa kod navedenog pacijenta koji boluje od kronične ili akutne bolesti ili akutnog stanja.
22. Farmaceutska formulacija namijenjena upotrebi u skladu s patentnih zahtjeva 15 do 17, naznačena time što navedenu farmaceutsku formulaciju treba primijeniti sistemno infuzijom na pacijentu radi sprječavanja ili smanjivanja disfunkcije organa ili insuficijencije organa kod navedenog pacijenta koji boluje od kronične ili akutne bolesti ili akutnog stanja.
HRP20191010TT 2011-11-16 2012-11-16 Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem HRP20191010T1 (hr)

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