HRP20200566T1 - Novi kombinirani tretman za akutnu mijeloidnu leukemiju (aml) - Google Patents
Novi kombinirani tretman za akutnu mijeloidnu leukemiju (aml) Download PDFInfo
- Publication number
- HRP20200566T1 HRP20200566T1 HRP20200566TT HRP20200566T HRP20200566T1 HR P20200566 T1 HRP20200566 T1 HR P20200566T1 HR P20200566T T HRP20200566T T HR P20200566TT HR P20200566 T HRP20200566 T HR P20200566T HR P20200566 T1 HRP20200566 T1 HR P20200566T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical product
- compound
- use according
- formula
- mdm2
- Prior art date
Links
- 208000031261 Acute myeloid leukaemia Diseases 0.000 title claims 3
- 238000011284 combination treatment Methods 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 10
- 229940127557 pharmaceutical product Drugs 0.000 claims 10
- 150000001875 compounds Chemical class 0.000 claims 8
- 239000003112 inhibitor Substances 0.000 claims 4
- 230000003993 interaction Effects 0.000 claims 4
- UHDGCWIWMRVCDJ-CCXZUQQUSA-N Cytarabine Chemical compound O=C1N=C(N)C=CN1[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O1 UHDGCWIWMRVCDJ-CCXZUQQUSA-N 0.000 claims 2
- 229960000684 cytarabine Drugs 0.000 claims 2
- 229920001427 mPEG Polymers 0.000 claims 2
- 229940083338 MDM2 inhibitor Drugs 0.000 claims 1
- 239000012819 MDM2-Inhibitor Substances 0.000 claims 1
Classifications
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
- A61K31/77—Polymers containing oxygen of oxiranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pyrrole Compounds (AREA)
- Saccharide Compounds (AREA)
Claims (11)
1. Farmaceutski proizvod, naznačen time, da sadrži a) inhibitor interakcije MDM2-p53 kao prvu komponentu; i b) citarabin kao drugu komponentu; kao kombinirani pripravak za uzastopnu ili istodobnu uporabu u liječenju akutne mijeloidne leukemije (AML), gdje je inhibitor MDM2 u a) spoj formule (I)
[image]
u kojem je n od 3 do 70, ili spoj formule (A)
[image]
2. Farmaceutski proizvod za uporabu prema patentnom zahtjevu 1, naznačen time, da je n od 30 do 60.
3. Farmaceutski proizvod za uporabu prema patentnom zahtjevu 1, naznačen time, da je n od 40 do 50.
4. Farmaceutski proizvod za uporabu prema patentnom zahtjevu 1, naznačen time, da je n: 41, 42, 43, 44, 46, 47, 48 ili 49.
5. Farmaceutski proizvod za uporabu u skladu s patentnim zahtjevom 1, naznačen time, da inhibitor interakcije MDM2-p53 je 4-{[(2R, 3S, 4R, 5S)-3-(3-kloro-2-fluoro-fenil)-4-(4-kloro-2-fluoro-fenil)-4-cijano-5-(2,2-dimetil-propil)-pirolidin-2-karbonil]-amino}-3-metoksi-benzojeva kiselina-1-mPEG-karboniloksi-etilni ester (mPEG, prosječna MW, ~2000).
6. Farmaceutski proizvod za uporabu u skladu s patentnim zahtjevom 1, naznačen time, da inhibitor interakcije MDM2-p53 je 4-{[(2R, 3S, 4R, 5S)-3-(3-kloro-2-fluoro-fenil)-4-(4-kloro-2-fluoro-fenil)-4-cijano-5-(2,2-dimetil-propil)-pirolidin-2-karbonil]-amino}-3-metoksi-benzojeva kiselina-1-mPEG-karboniloksi-etilni ester (mPEG, prosječna MW, ~2200).
7. Farmaceutski proizvod za uporabu u skladu s patentnim zahtjevom 1, naznačen time, da inhibitor interakcije MDM2-p53 je spoj formule (A) definiran u patentnom zahtjevu 1.
8. Spoj formule (I) ili (A) prema bilo kojem od patentnih zahtjeva 1 do 6 i citarabin, naznačeni time, da služe za uporabu u liječenju akutne mijeloidne leukemije (AML).
9. Farmaceutski proizvod za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time, da se obje komponente primjenjuju intravenski, te time, da doza spoja formule (I) odgovara dozi spoja (A)
[image]
unutar raspona od oko 200 do oko 1600 mg/dan.
10. Farmaceutski proizvod za uporabu u skladu s patentnim zahtjevom 9, naznačen time, da se spoj formule (I) primjenjuje od 1. do 5. dana, nakon čega slijedi period od 23 dana odmora, što zajedno čini ciklus liječenja od 28 dana.
11. Farmaceutski proizvod za uporabu u skladu s patentnim zahtjevom 10, naznačen time, da se spoj formule (I) daje jedanput dnevno (qd) ili dvaput dnevno (BID).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361912152P | 2013-12-05 | 2013-12-05 | |
| PCT/EP2014/076063 WO2015082384A1 (en) | 2013-12-05 | 2014-12-01 | Novel combination treatment for acute myeloid leukemia (aml) |
| EP14808911.3A EP3077004B1 (en) | 2013-12-05 | 2014-12-01 | Novel combination treatment for acute myeloid leukemia (aml) |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200566T1 true HRP20200566T1 (hr) | 2020-06-26 |
Family
ID=52014047
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200566TT HRP20200566T1 (hr) | 2013-12-05 | 2020-04-07 | Novi kombinirani tretman za akutnu mijeloidnu leukemiju (aml) |
Country Status (31)
| Country | Link |
|---|---|
| US (5) | US20160303158A1 (hr) |
| EP (1) | EP3077004B1 (hr) |
| JP (3) | JP6297695B2 (hr) |
| KR (1) | KR101862955B1 (hr) |
| CN (1) | CN105792847B (hr) |
| AR (1) | AR098576A1 (hr) |
| AU (1) | AU2014359422B2 (hr) |
| BR (1) | BR112016009669B1 (hr) |
| CA (1) | CA2926307C (hr) |
| CL (1) | CL2016001345A1 (hr) |
| CR (1) | CR20160173A (hr) |
| DK (1) | DK3077004T3 (hr) |
| EA (1) | EA201690785A1 (hr) |
| ES (1) | ES2785203T3 (hr) |
| HK (1) | HK1222808A1 (hr) |
| HR (1) | HRP20200566T1 (hr) |
| HU (1) | HUE049434T2 (hr) |
| IL (1) | IL244888B (hr) |
| LT (1) | LT3077004T (hr) |
| MA (1) | MA39040A1 (hr) |
| MX (1) | MX370618B (hr) |
| PE (1) | PE20160591A1 (hr) |
| PH (1) | PH12016500933A1 (hr) |
| PL (1) | PL3077004T3 (hr) |
| PT (1) | PT3077004T (hr) |
| RS (1) | RS60142B1 (hr) |
| SG (1) | SG11201604504VA (hr) |
| SI (1) | SI3077004T1 (hr) |
| TW (2) | TWI627954B (hr) |
| WO (1) | WO2015082384A1 (hr) |
| ZA (1) | ZA201602829B (hr) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101730708B (zh) | 2007-03-28 | 2013-09-18 | 哈佛大学校长及研究员协会 | 缝合多肽 |
| SI2603600T1 (sl) | 2010-08-13 | 2019-04-30 | Aileron Therapeutics, Inc. | Peptidomimetični makrocikli |
| WO2013059525A1 (en) | 2011-10-18 | 2013-04-25 | Aileron Therapeutics, Inc. | Peptidomimetic macrocyles |
| EP2914256B1 (en) | 2012-11-01 | 2019-07-31 | Aileron Therapeutics, Inc. | Disubstituted amino acids and methods of preparation and use thereof |
| SG11201604504VA (en) * | 2013-12-05 | 2016-07-28 | Hoffmann La Roche | Novel combination treatment for acute myeloid leukemia (aml) |
| TW201613576A (en) | 2014-06-26 | 2016-04-16 | Novartis Ag | Intermittent dosing of MDM2 inhibitor |
| BR112017005736A2 (pt) | 2014-09-24 | 2017-12-12 | Aileron Therapeutics Inc | macrociclos peptidomiméticos e formulações dos mesmos |
| EP3197478A4 (en) | 2014-09-24 | 2018-05-30 | Aileron Therapeutics, Inc. | Peptidomimetic macrocycles and uses thereof |
| US10253067B2 (en) | 2015-03-20 | 2019-04-09 | Aileron Therapeutics, Inc. | Peptidomimetic macrocycles and uses thereof |
| KR20180043835A (ko) * | 2015-09-03 | 2018-04-30 | 에일러론 테라퓨틱스 인코포레이티드 | 펩티도미메틱 매크로사이클 및 이의 용도 |
| US10023613B2 (en) | 2015-09-10 | 2018-07-17 | Aileron Therapeutics, Inc. | Peptidomimetic macrocycles as modulators of MCL-1 |
| JP7163281B2 (ja) * | 2016-06-06 | 2022-10-31 | セルジーン コーポレイション | ２－（４－クロロフェニル）－ｎ－（（２－（２，６－ジオキソピペリジン－３－イル）－１－オキソイソインドリン－５－イル）メチル）－２，２－ジフルオロアセトアミドによる血液系悪性腫瘍の治療 |
| WO2018027477A1 (zh) * | 2016-08-08 | 2018-02-15 | 肖飞 | 螺环吲哚酮聚乙二醇碳酸酯类化合物和其组合物、制备方法及用途 |
| JP6890659B2 (ja) | 2016-11-15 | 2021-06-18 | ノバルティス アーゲー | ＨＤＭ２−ｐ５３相互作用阻害剤の用量およびレジメン |
| US20200281925A1 (en) * | 2017-03-31 | 2020-09-10 | Novartis Ag | Dose and regimen for an hdm2-p53 interaction inhibitor in hematological tumors |
| US11091522B2 (en) | 2018-07-23 | 2021-08-17 | Aileron Therapeutics, Inc. | Peptidomimetic macrocycles and uses thereof |
| JP7126556B2 (ja) | 2018-09-28 | 2022-08-26 | 富士フイルム株式会社 | シタラビンを含む抗腫瘍剤、シタラビンと併用される抗腫瘍効果増強剤、抗腫瘍用キット、およびシタラビンと併用される抗腫瘍剤 |
| TW202118488A (zh) * | 2019-07-26 | 2021-05-16 | 大陸商蘇州亞盛藥業有限公司 | Mdm2抑制劑的藥物組合物及其在預防和/或治療疾病中的用途 |
| EP4337228A1 (en) * | 2021-05-13 | 2024-03-20 | Nkarta, Inc. | Dosing regimens for cancer immunotherapy |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7125888B2 (en) * | 2002-05-02 | 2006-10-24 | Merck & Co., Inc. | Tyrosine kinase inhibitors |
| DE102005012681A1 (de) * | 2005-03-18 | 2006-09-21 | Weber, Lutz, Dr. | Neue 1,5-Dihydro-pyrrol-2-one |
| US8354444B2 (en) | 2008-09-18 | 2013-01-15 | Hoffmann-La Roche Inc. | Substituted pyrrolidine-2-carboxamides |
| CN101773408B (zh) * | 2010-01-15 | 2012-04-04 | 平荧 | 多功能排针结合电凝固技术提升下垂皮肤的装置 |
| JP2013523820A (ja) * | 2010-04-09 | 2013-06-17 | ザ、リージェンツ、オブ、ザ、ユニバーシティ、オブ、ミシガン | 疾患を処置する際に使用するためのｍｄｍ２阻害剤のバイオマーカー |
| JO2998B1 (ar) * | 2010-06-04 | 2016-09-05 | Amgen Inc | مشتقات بيبيريدينون كمثبطات mdm2 لعلاج السرطان |
| US20120010235A1 (en) * | 2010-07-12 | 2012-01-12 | Xin-Jie Chu | N-substituted pyrrolidines |
| US8993614B2 (en) * | 2012-03-15 | 2015-03-31 | F. Hoffmann-La Roche Ag | Substituted pyrrolidine-2-carboxamides |
| US9216170B2 (en) * | 2012-03-19 | 2015-12-22 | Hoffmann-La Roche Inc. | Combination therapy for proliferative disorders |
| SG11201604504VA (en) * | 2013-12-05 | 2016-07-28 | Hoffmann La Roche | Novel combination treatment for acute myeloid leukemia (aml) |
| US9657351B2 (en) * | 2013-12-06 | 2017-05-23 | Hoffman-La Roche Inc. | MRNA-based gene expression for personalizing patient cancer therapy with an MDM2 antagonist |
-
2014
- 2014-12-01 SG SG11201604504VA patent/SG11201604504VA/en unknown
- 2014-12-01 WO PCT/EP2014/076063 patent/WO2015082384A1/en active Application Filing
- 2014-12-01 AU AU2014359422A patent/AU2014359422B2/en active Active
- 2014-12-01 US US15/101,258 patent/US20160303158A1/en not_active Abandoned
- 2014-12-01 JP JP2016536634A patent/JP6297695B2/ja active Active
- 2014-12-01 BR BR112016009669-0A patent/BR112016009669B1/pt active IP Right Grant
- 2014-12-01 PT PT148089113T patent/PT3077004T/pt unknown
- 2014-12-01 CA CA2926307A patent/CA2926307C/en active Active
- 2014-12-01 AR ARP140104469A patent/AR098576A1/es unknown
- 2014-12-01 PL PL14808911T patent/PL3077004T3/pl unknown
- 2014-12-01 EA EA201690785A patent/EA201690785A1/ru unknown
- 2014-12-01 EP EP14808911.3A patent/EP3077004B1/en active Active
- 2014-12-01 KR KR1020167014756A patent/KR101862955B1/ko active IP Right Grant
- 2014-12-01 MX MX2016007170A patent/MX370618B/es active IP Right Grant
- 2014-12-01 RS RS20200394A patent/RS60142B1/sr unknown
- 2014-12-01 LT LTEP14808911.3T patent/LT3077004T/lt unknown
- 2014-12-01 PE PE2016000615A patent/PE20160591A1/es not_active Application Discontinuation
- 2014-12-01 SI SI201431551T patent/SI3077004T1/sl unknown
- 2014-12-01 CN CN201480066531.9A patent/CN105792847B/zh active Active
- 2014-12-01 DK DK14808911.3T patent/DK3077004T3/da active
- 2014-12-01 ES ES14808911T patent/ES2785203T3/es active Active
- 2014-12-01 HU HUE14808911A patent/HUE049434T2/hu unknown
- 2014-12-03 TW TW103142020A patent/TWI627954B/zh active
- 2014-12-03 TW TW107105068A patent/TWI678204B/zh active
- 2014-12-04 US US14/560,086 patent/US9956243B2/en active Active
-
2016
- 2016-04-04 IL IL244888A patent/IL244888B/en active IP Right Grant
- 2016-04-14 CR CR20160173A patent/CR20160173A/es unknown
- 2016-04-25 ZA ZA2016/02829A patent/ZA201602829B/en unknown
- 2016-05-17 MA MA39040A patent/MA39040A1/fr unknown
- 2016-05-19 PH PH12016500933A patent/PH12016500933A1/en unknown
- 2016-06-02 CL CL2016001345A patent/CL2016001345A1/es unknown
- 2016-09-22 HK HK16111115.9A patent/HK1222808A1/zh unknown
-
2018
- 2018-02-21 JP JP2018028482A patent/JP6918724B2/ja active Active
-
2020
- 2020-02-19 US US16/794,991 patent/US20200253999A1/en not_active Abandoned
- 2020-04-07 HR HRP20200566TT patent/HRP20200566T1/hr unknown
-
2021
- 2021-02-05 JP JP2021017415A patent/JP2021091690A/ja active Pending
- 2021-05-19 US US17/324,248 patent/US20220031726A1/en not_active Abandoned
-
2023
- 2023-04-03 US US18/130,016 patent/US20230381215A1/en active Pending
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