HRP20231131T1 - Protutumorski farmaceutski pripravci za kombiniranu terapiju - Google Patents

Protutumorski farmaceutski pripravci za kombiniranu terapiju Download PDF

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Publication number
HRP20231131T1
HRP20231131T1 HRP20231131TT HRP20231131T HRP20231131T1 HR P20231131 T1 HRP20231131 T1 HR P20231131T1 HR P20231131T T HRP20231131T T HR P20231131TT HR P20231131 T HRP20231131 T HR P20231131T HR P20231131 T1 HRP20231131 T1 HR P20231131T1
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Croatia
Prior art keywords
cancer
pharmaceutical preparation
body weight
pi3kca
use according
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HRP20231131TT
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English (en)
Inventor
Giuseppe MERLINO
Mario Bigioni
Monica Binaschi
Andrea PELLACANI
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Berlin-Chemie Ag
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Publication of HRP20231131T1 publication Critical patent/HRP20231131T1/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
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (15)

1. Farmaceutski pripravak, naznačeno time, koji kao aktivni spoj sadrži inhibitorski spoj PI3K-klase I: 5-(7-metansulfonil-2-morfolin-4-il-6,7-dihidro-5H-pirolo[2,3-d]pirimidin-4-il)-pirimidin-2-amin ili njegovu farmaceutski prihvatljivu sol, za uporabu u liječenju protiv raka zajedno s drugim spojem protiv raka i pri čemu je navedeni drugi spoj protiv raka odabran iz skupine koja sadrži cetuksimab, bevacizumab, fulvestrant , ili gefitinib.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačeno time, da se koristi u liječenju raka debelog crijeva, raka prostate, raka dojke, raka pluća, raka jajnika.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 2, naznačeno time, da je za uporabu u liječenju raka debelog crijeva s mutacijama PI3KCA i divljeg tipa KRAS, raka debelog crijeva s mutacijama PI3KCA i KRAS, raka pluća nemalih stanica (NSCLC) sa ili bez mutacije na PI3KCA i EGFR, HER2-pozitivni rak dojke s PI3KCA mutacijom, HER2-pozitivan i ER-pozitivan rak dojke.
4. Farmaceutski pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačeno time, da je prikladan za oralnu primjenu inhibitora PI3k-klase I, za uporabu u kombinaciji s pripravkom koji sadrži drugi spoj protiv raka.
5. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 4, naznačeno time, da sadrži količinu inhibitora PI3K-klase 1 dovoljnu za jediničnu dozu od 1 do 10 mg/kg tjelesne težine.
6. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 5, naznačeno time, da je za jediničnu dozu inhibitora PI3K-klase 1 od 5 do 7 mg/kg tjelesne težine.
7. Farmaceutski pripravak za uporabu u skladu s bilo kojim od patentnih zahtjeva 4 do 6, naznačeno time, da se koristi zajedno s farmaceutskim pripravkom koji je prikladan za oralnu ili parenteralnu primjenu drugog spoja protiv raka.
8. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 7, naznačeno time, da se koristi zajedno s farmaceutskim pripravkom koji sadrži količinu drugog spoja protiv raka prikladnu za jediničnu dozu od 10 do 80 mg/kg tjelesne težine.
9. Farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 8, naznačeno time, da se koristi zajedno s farmaceutskim pripravkom koji sadrži količinu drugog spoja protiv raka prikladnu za jediničnu dozu od 20 do 70 mg/kg tjelesne težine, poželjno od 30 do 50 mg/kg tjelesna težina.
10. Komplet dijelova, naznačeno time, da sadrži farmaceutski pripravak koji kao aktivni spoj sadrži spoj inhibitor PI3K-klase I: 5-(7-metansulfonil-2-morfolin-4-il-6,7-dihidro-5H-pirolo[2, 3-d]pirimidin- 4-il)-pirimidin-2-amin ili njegovu farmaceutski prihvatljivu sol, i drugi farmaceutski pripravak koji sadrži drugi spoj protiv raka, a pri čemu je navedeni drugi spoj protiv raka odabran iz skupine koja sadrži cetuksimab, bevacizumab, fulvestrant ili gefitinib, za uporabu u kombiniranom liječenju protiv raka.
11. Komplet dijelova za uporabu u skladu s patentnim zahtjevom 10, naznačeno time, gdje je kombinirani tretman protiv raka debelog crijeva, prostate, dojke, pluća i jajnika.
12. Komplet dijelova u skladu s patentnim zahtjevom 11, naznačeno time, da je za uporabu u kombiniranom liječenju raka debelog crijeva s mutacijama PI3KCA i divljeg tipa KRAS, raka debelog crijeva s mutacijama PI3KCA i KRAS, raka pluća nemalih stanica (NSCLC) sa ili bez mutacije na PI3KCA i EGFR, HER2-pozitivan rak dojke s PI3KCA mutacijom, HER2-pozitivan i ER-pozitivan rak dojke.
13. Komplet dijelova za uporabu u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačeno time, da prvi farmaceutski pripravak sadrži količinu inhibitora PI3K-klase 1 dovoljnu za jediničnu dozu od 1 do 10 mg/kg tjelesne težine, poželjno od 5 do 7 mg/kg tjelesne težine.
14. Komplet dijelova za uporabu u skladu s patentnim zahtjevom 13, naznačeno time, što drugi pripravak sadrži količinu drugog spoja protiv raka prikladnu za jediničnu dozu od 10 do 80 mg/kg tjelesne težine, poželjno od 20 do 70 mg/kg ili od 30 do 50 mg /kg tjelesne težine.
15. Komplet dijelova za uporabu u skladu s bilo kojim od patentnih zahtjeva 10 do 14, naznačeno time, da je prvi pripravak prikladan za oralnu primjenu inhibitora PI3k-klase I, a drugi pripravak je prikladan za oralnu ili parenteralnu primjenu.
HRP20231131TT 2018-03-29 2019-03-28 Protutumorski farmaceutski pripravci za kombiniranu terapiju HRP20231131T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT102018000004082A IT201800004082A1 (it) 2018-03-29 2018-03-29 Composizioni farmaceutiche antitumorali per terapia combinata
PCT/IB2019/052541 WO2019186451A1 (en) 2018-03-29 2019-03-28 Anticancer pharmaceutical compositions for combined therapy
EP19721103.0A EP3773595B1 (en) 2018-03-29 2019-03-28 Anticancer pharmaceutical compositions for combined therapy

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HRP20231131T1 true HRP20231131T1 (hr) 2024-01-05

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US (1) US20210015826A1 (hr)
EP (1) EP3773595B1 (hr)
JP (1) JP7460596B2 (hr)
KR (1) KR20200138294A (hr)
CN (1) CN111918656B (hr)
AU (1) AU2019244793A1 (hr)
BR (1) BR112020019712A2 (hr)
CL (1) CL2020002424A1 (hr)
DK (1) DK3773595T3 (hr)
EA (1) EA202092008A1 (hr)
ES (1) ES2954502T3 (hr)
FI (1) FI3773595T3 (hr)
HR (1) HRP20231131T1 (hr)
HU (1) HUE063047T2 (hr)
IL (1) IL277649A (hr)
IT (1) IT201800004082A1 (hr)
LT (1) LT3773595T (hr)
MX (1) MX2020010084A (hr)
PH (1) PH12020551583A1 (hr)
PL (1) PL3773595T3 (hr)
PT (1) PT3773595T (hr)
RS (1) RS64639B1 (hr)
RU (1) RU2020131376A (hr)
SG (1) SG11202009483YA (hr)
SI (1) SI3773595T1 (hr)
TW (1) TWI816768B (hr)
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CN113368114B (zh) * 2020-03-10 2022-04-22 四川大学 一种吗啉嘧啶类化合物的抗肿瘤应用
WO2024023766A1 (en) * 2022-07-28 2024-02-01 Berlin-Chemie Ag P13k inhibitor combination therapy

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EP3042964A1 (en) * 2004-06-04 2016-07-13 Genentech, Inc. Egfr mutations
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EP2616078B1 (en) * 2010-09-16 2019-12-25 Shimoda Biotech (Pty) Ltd Fulvestrant compositions and methods of use
WO2012118978A1 (en) * 2011-03-03 2012-09-07 The Regents Of The University Of Colorado, A Body Corporate Methods for treating oncovirus positive cancers
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PT2968294T (pt) * 2013-03-13 2019-07-19 Oncoceutics Inc 7-benzil-10-(2-metilbenzil)-2,6,7,8,9,10-hexahidroimidazo[1,2-a]pirido[4,3-d]pirimidin-5(3h)-ona para utilização no tratamento de cancro
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FR3033499A1 (fr) * 2015-03-11 2016-09-16 Centre Leon-Berard Composition pour le traitement des tumeurs neuroendocrines pancreatiques
WO2016193955A1 (en) * 2015-06-04 2016-12-08 Giorgio Stassi Combinations of kinase inhibitors for treating colorectal cancer

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Publication number Publication date
IT201800004082A1 (it) 2019-09-29
FI3773595T3 (fi) 2023-09-01
MX2020010084A (es) 2021-01-15
ES2954502T3 (es) 2023-11-22
RS64639B1 (sr) 2023-10-31
CN111918656A (zh) 2020-11-10
EP3773595A1 (en) 2021-02-17
SG11202009483YA (en) 2020-10-29
PT3773595T (pt) 2023-09-07
WO2019186451A1 (en) 2019-10-03
BR112020019712A2 (pt) 2021-02-09
CL2020002424A1 (es) 2021-03-12
EA202092008A1 (ru) 2021-01-18
LT3773595T (lt) 2023-09-25
TW202002984A (zh) 2020-01-16
DK3773595T3 (da) 2023-09-18
JP7460596B2 (ja) 2024-04-02
PH12020551583A1 (en) 2021-09-13
KR20200138294A (ko) 2020-12-09
US20210015826A1 (en) 2021-01-21
PL3773595T3 (pl) 2023-11-27
JP2021519821A (ja) 2021-08-12
AU2019244793A1 (en) 2020-10-08
RU2020131376A (ru) 2022-04-29
CN111918656B (zh) 2023-08-08
TWI816768B (zh) 2023-10-01
EP3773595B1 (en) 2023-07-12
SI3773595T1 (sl) 2023-11-30
HUE063047T2 (hu) 2023-12-28
IL277649A (en) 2020-11-30
UA127288C2 (uk) 2023-07-12

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