ME01209B - Kombinacija za lečenje bolesti koje obuhvataju ćelijsku proliferaciju - Google Patents
Kombinacija za lečenje bolesti koje obuhvataju ćelijsku proliferacijuInfo
- Publication number
- ME01209B ME01209B MEP-2011-124A MEP12411A ME01209B ME 01209 B ME01209 B ME 01209B ME P12411 A MEP12411 A ME P12411A ME 01209 B ME01209 B ME 01209B
- Authority
- ME
- Montenegro
- Prior art keywords
- amino
- therapeutic agent
- additional therapeutic
- group
- pharmaceutically acceptable
- Prior art date
Links
- 201000010099 disease Diseases 0.000 title claims 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title claims 8
- 230000004663 cell proliferation Effects 0.000 title claims 4
- 239000003814 drug Substances 0.000 claims 11
- 229940124597 therapeutic agent Drugs 0.000 claims 10
- 150000003839 salts Chemical class 0.000 claims 9
- 239000008194 pharmaceutical composition Substances 0.000 claims 7
- 229940125904 compound 1 Drugs 0.000 claims 6
- 150000001875 compounds Chemical class 0.000 claims 4
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Classifications
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic 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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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Claims (19)
1. Farmaceutska kompozicija koja sadrži efektivne količine: (i) jedinjenja 1 Formule (I) gde skraćenice X1, X2, X3, X4 i X5 korišćene u Tabeli u svakom slučaju označavaju poziciju u opštoj Formuli prikazanoj u Tabeli umesto odgovarajućih grupa R1, R1, R2, R4 i Ln-R5m, opciono u obliku njegovih tautomera, racemata, enantiomera, diastereomera i njegovih smeša i opciono u obliku njegovih farmaceutski prihvatljivih kiselih adicionih soli, solvata ili hidrata. (ii) barem jednog dodatnog terapeutskog agensa 2 odabranog iz grupe koja sadrži 4-[(3-hloro-4-fluorofenil)amino]-6-{[4-(N,N-dimetilamino)-1-okso-2-buten-1- il]amino}-7-((S)-tetrahidrofuran-3-iloksi)-hinazolin ili njegovu farmaceutski prihvatljivu so, 3-Z-[1-(4-(N-((4-metil-piperazin-1-il)-metilkarbonil)-N-metil-amino)- anilino)-1-fenil-metilen]-6-metoksikarbonil-2-indolinon, ili njegovu farmaceutski prihvatljivu so, jedinjenje platine izabrano iz grupe koja sadrži cisplatin, karboplatin, oksaliplatin, satraplatin, tetraplatin, iproplatin, mitomicin, streptozocin, karmustin (BCNU), lomustin (CCNU), busulfan, ifosfamid, streptozocin, tiotepa i hlorambucil, analog pirimidina ili purina ili anatagonist ili inhibitor nukleozid difosfat reduktaze izabran iz grupe koja sadrži citarabin, 5- fluorouracil (5-FU), permetreksed, tegafur/uracil, uracil mustard, fludarabin, gemcitabin, kapecitabin, merkaptopurin, kladribin, tioguanin, metotreksat, pentostatin, hidroksiureju i folnu kiselinu, kamptotecin izabran iz grupe koja sadrži irinotekan i topotekan, inhibitor histonske deacetilaze izabran iz grupe koja sadrži SAHA, MD-275, trihostatin A, CBHA, LAQ824 i valproičnu kiselinu, biljni anti-kancer izabran iz grupe koja sadrži paklitaksel, docetaksel i taksoter.
2. Farmaceutska kompozicija prema zahtevu 1, gde je jedinjenje 1 odabrano iz sledećeg jedinjenjagde skraćenice X1, X2, X3, X4 i X5 korišćene u Tabeli u svakom slučaju označavaju poziciju u opštoj Formuli prikazanoj u Tabeli umesto odgovarajućih grupa R1, R2, R3, R4 i L-R5
3. Farmaceutska kompozicija prema zahtevu 1, gde je jedinjenje 1 odabrano iz sledećeg jedinjenjagde skraćenice X1, X2, X3, X4 i X5 korišćene u Tabeli u svakom slučaju označavaju poziciju u opštoj Formuli prikazanoj u Tabeli umesto odgovarajućih grupa R1, R2, R3, R4 i Ln-R5m.
4.Farmaceutska kompozicija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 derivat hinazolina 4-[(3-hloro-4-fluorofenil)amino]-6-{[4-(N,N- dimetilamino)-1-okso-2-buten-1-il)]amino}-7-((S)-tetrahidrofuran-3-iloksi)-hinazolin ili njegova farmaceutski prihvatljiva so.
5. Farmaceutska kombinacija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 so di-maleinske kiseline jedinjenja 4-[(3-hloro-4-fluorofenil) amino]-6-{[4-(N,N-dimetilamino)-1-okso-2-buten-1-il)]amino}-7-((S)-tetrahidrofuran- 3-iloksi)hinazolin, ili 4-[(3-hloro-4-fluorofenil)amino]-6-{[4-(homomorfolin-4-il)-1- okso-2-buten-1-il]amino}-7-[(S)-(tetrahidrofuran-3-il)oksi]-hinazolin, ili njegovi tautomeri, stereoizomeri ili njegova farmaceutski prihvatljiva so.
6. Farmaceutska kombinacija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 4-[(3-hloro-4-fluoro-fenil)amino]-6-{[4-(homomorfolin-4-il)-1- okso-2-buten-1-il]amino}-7-[(S)-(tetrahidrofuran-3-il)oksi]-hinazolin,ili njegovi tautomeri, stereoizomeri ili farmaceutski prihvatljiva so.
7.Farmaceutska kombinacija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 3-Z-[1-(4-(N-((4-metil)-piperazin-1-il)-metilkarbonil)-N-metil- amino)anilino)-1-fenil-metilen]-6-metoksikarbonil-2-indolinon ili njegova farmaceutski prihvatljiva so.
8.Farmaceutska kombinacija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 so monoetansulfonat 3-Z-[1-(4-(N-((4-metil-piperazin-1-il)- metilkarbonil)-N-metil-amino)-anilino)-1-fenilmetilen]-6-metoksikarbonil-2-indolinon.
9. Farmaceutska kombinacija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 3-Z-[1-(4-dimetilaminometilanilino)-1-(4-(2-karboksietil) fenil)metilen]-6-fluoro-2-indolinon ili njegova farmaceutski prihvatljiva so.
10.Farmaceutska kompozicija prema bilo kom od zahteva 1 do 3, gde je dodatni terapeutski agens 2 odabran iz grupe koja sadrži irinotekan, topotekan, oksaliplatin, docetaksel, paklitaksel, gemcitabin, pemetreksed, cisplatin ili karboplatin,
11.Farmaceutska kompozicija prema bilo kom od zahteva 1 do 10 za primenu u lečenju onkološke bolesti.
12.Primena prema zahtevu 11, gde je onkološka bolest odabrana iz grupe koja se sastoji od čvrstih tumora.
13.Primena prema zahtevu 11, gde je onkološka bolest odabrana iz grupe koja se sastoji od urogenitalnih kancera, plućnih kancera, gastrointestinalnih kancera, kancera glave i vrata, maligne mezoteliome, kancera dojke, malignog melanoma, kancera kod dece, sarkome kostiju ili mekog tkiva.
14.Primena prema zahtevu 11 gde je onkološka bolest odabrana iz grupe koja se sastoji od refraktornog ili relapsirajućeg oblika multiplog mijeloma, akutne ili hronične mijeloidne leukemije, mijelodisplastičnog sindroma, mijeloproliferativnih sindroma, akutne limfoblastične leukemije, Hočkinovog i Nehočkinovog limfoma.
15. Komplet za dobijanje farmacetske kombinacije za lečenje bolesti koje obuhvataju ćelijsku proliferaciju, migraciju ili apoptozu kancerogenih ćelija, ili angiogenezu, koji sadrži terapeutski efektivnu količinu: (i) jedinjenja 1 Formule (I) kao što je definisano u bilo kom od zahteva 1 do 3; i (ii) najmanje dodatnog terapeutskog agensa 2 kao što je definisan u bilo kom od zahteva 1 do 10;
16. Komplet za dobijanje farmacetske kombinacije prema zahtevu 15, gde je formulacija jedinjenja 1 Formule (I) za oralnu primenu ili injekciju.
17.Farmaceutska kompozicija prema bilo kom od zahteva 1 do 10 ili komplet za dobijanje farmaceutske kombinacije prema zahtevima 15 ili 16, za proizvodnju leka, opciono prilagođena za istovremeno lečenje sa radioterapijom ili radio- imunoterapijom, za primenu u lečenju bolesti koje obuhvataju ćelijsku proliferaciju, migraciju ili apoptozu kancerogenih ćelija, ili angiogenezu, u ljudskom ili ne-ljudskom telu sisara.
18.Preparat farmaceutske kombinacije koji sadrži efektivnu količinu jedinjenja 1 Formule (I) kao što je definisano u bilo kom od zahteva 1 do 3 u kombinaciji sa najmanje dodatnim terapeutskim agensom 2 kao što je definisan u bilo kom od zahteva 1 do 10, opciono prilagođen za istovremeno lečenje sa radioterapijom ili radio-imunoterapijom, za istovremenu, odvojenu ili sekvencijalnu primenu u lečenju bolesti koje obuhvataju ćelijsku proliferaciju, migraciju ili apoptozu kancerogenih ćelija, ili angiogenezu, u ljudskom ili ne-ljudskom telu sisara.
19. Primena prema bilo kom od zahteva 11 do 14, 17 ili 18, naznačena time što se jedinjenje 1. Formule (I), ili njegov hidrat ili farmaceutski prihvatljiva so, primenjuje intermitentno ili u dnevnoj dozi tako da nivo aktivne supstance u plazmi leži između 10 i 5000 nM u najmanje 12 sati doznog intervala.
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| PCT/EP2005/008623 WO2006018182A1 (en) | 2004-08-14 | 2005-08-09 | Combinations for the treatment of diseases involving cell proliferation |
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-
2005
- 2005-07-26 US US11/189,540 patent/US20060058311A1/en not_active Abandoned
- 2005-08-09 EP EP10184338.1A patent/EP2275107B1/en not_active Expired - Lifetime
- 2005-08-09 PT PT05770228T patent/PT1827441E/pt unknown
- 2005-08-09 PL PL10184338T patent/PL2275107T3/pl unknown
- 2005-08-09 HU HUE10184338A patent/HUE032436T2/en unknown
- 2005-08-09 WO PCT/EP2005/008623 patent/WO2006018182A1/en not_active Ceased
- 2005-08-09 PL PL05770228T patent/PL1827441T3/pl unknown
- 2005-08-09 KR KR1020077005955A patent/KR101258426B1/ko not_active Expired - Fee Related
- 2005-08-09 MX MX2007001853A patent/MX2007001853A/es active IP Right Grant
- 2005-08-09 HR HR20110578T patent/HRP20110578T1/hr unknown
- 2005-08-09 DK DK05770228.4T patent/DK1827441T3/da active
- 2005-08-09 AT AT05770228T patent/ATE512663T1/de active
- 2005-08-09 ES ES10184338.1T patent/ES2602465T3/es not_active Expired - Lifetime
- 2005-08-09 CN CN2005800352724A patent/CN101039673B/zh not_active Expired - Fee Related
- 2005-08-09 RU RU2007109108/15A patent/RU2407532C9/ru not_active IP Right Cessation
- 2005-08-09 JP JP2007526349A patent/JP5043660B2/ja not_active Expired - Lifetime
- 2005-08-09 NZ NZ553729A patent/NZ553729A/en not_active IP Right Cessation
- 2005-08-09 AU AU2005274384A patent/AU2005274384B2/en not_active Ceased
- 2005-08-09 RS RS20110302A patent/RS51807B/sr unknown
- 2005-08-09 ME MEP-2011-124A patent/ME01209B/me unknown
- 2005-08-09 SI SI200531347T patent/SI1827441T1/sl unknown
- 2005-08-09 BR BRPI0514357-8A patent/BRPI0514357A/pt active Search and Examination
- 2005-08-09 DK DK10184338.1T patent/DK2275107T3/en active
- 2005-08-09 EP EP05770228A patent/EP1827441B1/en not_active Expired - Lifetime
- 2005-08-09 CA CA2576269A patent/CA2576269C/en not_active Expired - Fee Related
- 2005-08-12 TW TW100137048A patent/TW201201810A/zh unknown
- 2005-08-12 TW TW094127595A patent/TWI361071B/zh active
- 2005-08-12 AR ARP050103380A patent/AR050521A1/es unknown
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2007
- 2007-02-13 IL IL181305A patent/IL181305A/en not_active IP Right Cessation
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2009
- 2009-05-07 US US12/437,280 patent/US8143247B2/en not_active Expired - Lifetime
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2010
- 2010-09-01 RU RU2010136326/15A patent/RU2521394C2/ru not_active IP Right Cessation
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