HRP20230300T1 - Kombinacije imetelstata i venetoklaksa za liječenje akutne mijeloidne leukemije - Google Patents

Kombinacije imetelstata i venetoklaksa za liječenje akutne mijeloidne leukemije Download PDF

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Publication number
HRP20230300T1
HRP20230300T1 HRP20230300TT HRP20230300T HRP20230300T1 HR P20230300 T1 HRP20230300 T1 HR P20230300T1 HR P20230300T T HRP20230300T T HR P20230300TT HR P20230300 T HRP20230300 T HR P20230300T HR P20230300 T1 HRP20230300 T1 HR P20230300T1
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HR
Croatia
Prior art keywords
imetelstat
abt
use according
combination
sodium
Prior art date
Application number
HRP20230300TT
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English (en)
Inventor
Fei Huang
Joshua J. RUSBULDT
Aleksandra RIZO
Original Assignee
Geron Corporation
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Publication date
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Publication of HRP20230300T1 publication Critical patent/HRP20230300T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • A61K31/7125Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Claims (21)

1. Imetelstat za uporabu u liječenju akutne mijeloidne leukemije (AML) kod pacijenata koji se liječe sa ABT-199 ili njegovom farmaceutski prihvatljivom soli.
2. ABT-199 ili njegova farmaceutski prihvatljiva sol za uporabu u liječenju akutne mijeloidne leukemije (AML) kod pacijenata koji su podvrgnuti liječenju imtelstatom.
3. Imetelstat za uporabu u postupku liječenja akutne mijeloidne leukemije (AML), pri čemu postupak obuhvaća davanje imetelstata i ABT-199 ili njegove farmaceutski prihvatljive soli u kombinaciji subjektu kojem je to potrebno.
4. Kombinacija koja sadrži imetelstat i ABT-199 ili njihovu farmaceutski prihvatljivu sol za uporabu u postupku liječenja akutne mijeloidne leukemije (AML), pri čemu postupak obuhvaća davanje kombinacije subjektu kojem je to potrebno.
5. Imetelstat za uporabu prema patentnim zahtjevima 1-3 ili kombinacija za uporabu prema patentnom zahtjevu 4, pri čemu je imetelstat natrij imetelstat.
6. Imetelstat za uporabu prema patentnim zahtjevima 1-3 ili kombinacija za uporabu prema patentnom zahtjevu 4, pri čemu se imetelstat primjenjuje za 1, 2, 3, 4, 5, 6, 7, 8 ili više od 8 ciklusa doziranja, pri čemu svaki ciklus doziranja sadrži: (a) intravensku primjenu 7 - 10 mg/kg imetelstata jednom u četiri tjedna; (b) intravensku primjenu 7 - 10 mg/kg imetelstata jednom tjedno tijekom četiri tjedna; (c) intravensku primjenu 2.5 - 7 mg/kg imetelstata jednom u tri tjedna; ili (d) intravensku primjenu 0.5 - 9.4 mg/kg imetelstata jednom u četiri tjedna.
7. Imetelstat za uporabu prema patentnom zahtjevu 6 ili kombinacija za uporabu prema zahtjevu 6, gdje je imetelstat natrij imetelstat.
8. Imetelstat za uporabu prema patentnim zahtjevima 1-3 ili kombinacija za uporabu prema patentnom zahtjevu 4, gdje je ABT-199 za primjenu u dozi od: (a) 50 - 400 mg ABT-199 dnevno; (b) 2 mg ABT-199 prvog dana sa dnevnom eskalacijom do konačne doze od 800 mg 6 dana i dnevno nakon toga; ili (c) 25 mg ABT-199 prvog dana sa dnevnom eskalacijom do konačne doze od 400 mg 5 dana i dnevno nakon toga.
9. Imetelstat za uporabu prema patentnim zahtjevima 1-3 ili kombinacija za uporabu prema patentnom zahtjevu 4, pri čemu je primjena ABT-199 jedan dan prije, jedan dan poslije ili istog dana kada je primjena imetelstata.
10. Imetelstat natrij za uporabu u postupku liječenja akutne mijeloidne leukemije (AML) prema patentnom zahtjevu 3, pri čemu postupak obuhvaća davanje imetelstat natrija i ABT-199 u kombinaciji subjektu kojem je to potrebno.
11. ABT-199 za uporabu u postupku liječenja akutne mijeloidne leukemije (AML) prema patentnom zahtjevu 2, pri čemu postupak obuhvaća davanje ABT-199 i imetelstat natrija u kombinaciji subjektu kojem je to potrebno.
12. Kombinacija koja sadrži imetelstat natrij i ABT-199 za uporabu u postupku liječenja akutne mijeloidne leukemije (AML) prema patentnom zahtjevu 4, pri čemu postupak obuhvaća davanje kombinacije subjektu kojem je to potrebno.
13. Imetelstat natrij za uporabu prema patentnom zahtjevu 10, ABT-199 za uporabu prema patentnom zahtjevu 11 ili kombinacija za uporabu prema patentnom zahtjevu 12, pri čemu se imetelstat natrij primjenjuje tokom 1, 2, 3, 4, 5, 6, 7, 8 ili više od 8 ciklusa doziranja, pri čemu svaki ciklus doziranja sadrži: (a) intravensku primjenu 7 - 10 mg/kg imetelstat natrija jednom u četiri tjedna; (b) intravensku primjenu 7 - 10 mg/kg imetelstat natrija jednom tjedno tijekom četiri tjedna; (c) intravensku primjenu 2.5 - 7 mg/kg imetelstat natrija jednom u tri tjedna; ili (d) intravensku primjenu 0.5 - 9.4 mg/kg imetelstat natrija jednom svaka četiri tjedna.
14. Imetelstat natrij za uporabu prema patentnom zahtjevu 10, ABT-199 za uporabu prema patentnom zahtjevu 11 ili kombinacija za uporabu prema patentnom zahtjevu 12, pri čemu se ABT-199 primjenjuje u dozi od: (a) 50 - 400 mg ABT-199 dnevno; (b) 2 mg ABT-199 prvog dana sa dnevnom eskalacijom do konačne doze od 800 mg 6 dana i dnevno nakon toga; ili (c) 25 mg ABT-199 prvog dana sa dnevnom eskalacijom do konačne doze od 400 mg 5 dana i dnevno nakon toga.
15. Imetelstat natrij za uporabu prema patentnom zahtjevu 10, ABT-199 za uporabu prema patentnom zahtjevu 11 ili kombinacija za uporabu prema patentnom zahtjevu 12, pri čemu se primjena ABT-199 vrši jedan dan prije, jedan dan poslije ili istog dana kada i primjena imetelstat natrija.
16. Komplet za uporabu u postupku liječenja akutne mijeloidne leukemije (AML), koji sadrži: (a) imetelstat; i (b) ABT-199 ili njegovu farmaceutski prihvatljivu sol.
17. Komplet prema patentnom zahtjevu 16, naznačen time da imetelstat je imetelstat natrij.
18. In vitro postupak za izazivanje apoptoze u stanici akutne mijeloidne leukemije (AML) koji se sastoji od: dovođenje stanice u kontakt sa terapeutski efikasnom količinom imetelstat natrija; i dovođenje stanice u kontakt sa terapeutski efikasnom količinom ABT-199.
19. Farmaceutski pripravak koji sadrži imetelstat i ABT-199.
20. Farmaceutski pripravak prema patentnim zahtjevu 19, naznačen time da imetelstat je imetelstat natrij.
21. Farmaceutski pripravak prema patentnom zahtjevu 19, naznačen time što je pripravak za uporabu u liječenju akutne mijeloidne leukemije.
HRP20230300TT 2016-08-02 2017-07-28 Kombinacije imetelstata i venetoklaksa za liječenje akutne mijeloidne leukemije HRP20230300T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662370018P 2016-08-02 2016-08-02
EP16197293.0A EP3318276A1 (en) 2016-11-04 2016-11-04 Combinations of a telomerase inhibitor and a bcl-2 inhibitor for the treatment of hematological cancers
US201662422738P 2016-11-16 2016-11-16
EP17748613.1A EP3493812B1 (en) 2016-08-02 2017-07-28 Combinations of imetelstat and venetoclax for the treatment of acute myeloid leukaemia
PCT/US2017/044348 WO2018026646A1 (en) 2016-08-02 2017-07-28 Combination treatment for hematological cancers

Publications (1)

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HRP20230300T1 true HRP20230300T1 (hr) 2023-05-12

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US (2) US11278561B2 (hr)
EP (3) EP3318276A1 (hr)
JP (2) JP7016856B2 (hr)
KR (2) KR102515378B1 (hr)
CN (2) CN109641002B (hr)
AU (2) AU2017305950B2 (hr)
BR (1) BR112019002025A2 (hr)
CA (2) CA3032118C (hr)
CL (1) CL2019000228A1 (hr)
DK (1) DK3493812T3 (hr)
ES (1) ES2941462T3 (hr)
FI (1) FI3493812T3 (hr)
HR (1) HRP20230300T1 (hr)
HU (1) HUE061471T2 (hr)
IL (2) IL305332A (hr)
LT (1) LT3493812T (hr)
MA (1) MA45845A (hr)
MD (1) MD3493812T2 (hr)
MX (2) MX2019001315A (hr)
NZ (1) NZ750191A (hr)
PL (1) PL3493812T3 (hr)
PT (1) PT3493812T (hr)
RS (1) RS64074B1 (hr)
SG (1) SG11201900883UA (hr)
SI (1) SI3493812T1 (hr)
WO (1) WO2018026646A1 (hr)
ZA (1) ZA201900939B (hr)

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EP4281560A1 (en) * 2021-01-22 2023-11-29 The Regents of the University of California Methods for treating and ameliorating cancer
CN114949230A (zh) * 2022-06-13 2022-08-30 厦门大学附属第一医院 一种预防和/或治疗急性髓系白血病的联合用药物组合物及其应用

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Also Published As

Publication number Publication date
MX2019001315A (es) 2019-07-01
EP3318276A1 (en) 2018-05-09
SI3493812T1 (sl) 2023-05-31
EP3493812B1 (en) 2023-01-04
JP2022145948A (ja) 2022-10-04
DK3493812T3 (da) 2023-04-11
JP7016856B2 (ja) 2022-02-07
CL2019000228A1 (es) 2019-05-17
JP2019523277A (ja) 2019-08-22
CA3217021A1 (en) 2018-02-08
EP4218768A1 (en) 2023-08-02
EP3493812A1 (en) 2019-06-12
BR112019002025A2 (pt) 2019-05-14
IL305332A (en) 2023-10-01
US11278561B2 (en) 2022-03-22
SG11201900883UA (en) 2019-02-27
FI3493812T3 (fi) 2023-04-14
RS64074B1 (sr) 2023-04-28
WO2018026646A1 (en) 2018-02-08
US20180036336A1 (en) 2018-02-08
CA3032118A1 (en) 2018-02-08
HUE061471T2 (hu) 2023-07-28
US20220168333A1 (en) 2022-06-02
CN109641002B (zh) 2022-10-18
KR20190049708A (ko) 2019-05-09
KR102515378B1 (ko) 2023-03-29
NZ750191A (en) 2023-03-31
AU2023229592A1 (en) 2023-10-05
AU2017305950A1 (en) 2019-02-21
IL264451B1 (en) 2023-09-01
CN109641002A (zh) 2019-04-16
MD3493812T2 (ro) 2023-05-31
MX2022010466A (es) 2022-09-19
ES2941462T3 (es) 2023-05-23
IL264451A (en) 2019-02-28
IL264451B2 (en) 2024-01-01
AU2017305950B2 (en) 2023-06-22
MA45845A (fr) 2019-06-12
CA3032118C (en) 2023-12-12
KR20230047206A (ko) 2023-04-06
LT3493812T (lt) 2023-04-11
ZA201900939B (en) 2023-04-26
PT3493812T (pt) 2023-03-30
CN116327954A (zh) 2023-06-27
PL3493812T3 (pl) 2023-05-08

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