JP2011506473A - キナーゼ阻害剤と組み合わせられたアルファチモシンペプチドによる黒色腫の処置の方法 - Google Patents
キナーゼ阻害剤と組み合わせられたアルファチモシンペプチドによる黒色腫の処置の方法 Download PDFInfo
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- JP2011506473A JP2011506473A JP2010538181A JP2010538181A JP2011506473A JP 2011506473 A JP2011506473 A JP 2011506473A JP 2010538181 A JP2010538181 A JP 2010538181A JP 2010538181 A JP2010538181 A JP 2010538181A JP 2011506473 A JP2011506473 A JP 2011506473A
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- 201000001441 melanoma Diseases 0.000 title claims abstract description 40
- 108010046075 Thymosin Proteins 0.000 title claims abstract description 30
- 229940043355 kinase inhibitor Drugs 0.000 title claims abstract description 22
- 239000003757 phosphotransferase inhibitor Substances 0.000 title claims abstract description 22
- 238000011282 treatment Methods 0.000 title claims description 48
- 238000000034 method Methods 0.000 title claims description 27
- 102000007501 Thymosin Human genes 0.000 title description 3
- 238000011269 treatment regimen Methods 0.000 claims abstract description 9
- 206010027476 Metastases Diseases 0.000 claims abstract description 7
- 230000009401 metastasis Effects 0.000 claims abstract description 5
- 238000002648 combination therapy Methods 0.000 claims abstract description 3
- 108010078233 Thymalfasin Proteins 0.000 claims description 96
- 102400000800 Thymosin alpha-1 Human genes 0.000 claims description 96
- NZVYCXVTEHPMHE-ZSUJOUNUSA-N thymalfasin Chemical compound CC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(O)=O NZVYCXVTEHPMHE-ZSUJOUNUSA-N 0.000 claims description 96
- 229960004231 thymalfasin Drugs 0.000 claims description 95
- MLDQJTXFUGDVEO-UHFFFAOYSA-N BAY-43-9006 Chemical compound C1=NC(C(=O)NC)=CC(OC=2C=CC(NC(=O)NC=3C=C(C(Cl)=CC=3)C(F)(F)F)=CC=2)=C1 MLDQJTXFUGDVEO-UHFFFAOYSA-N 0.000 claims description 52
- 239000005511 L01XE05 - Sorafenib Substances 0.000 claims description 52
- 229960003787 sorafenib Drugs 0.000 claims description 52
- FDKXTQMXEQVLRF-ZHACJKMWSA-N (E)-dacarbazine Chemical compound CN(C)\N=N\c1[nH]cnc1C(N)=O FDKXTQMXEQVLRF-ZHACJKMWSA-N 0.000 claims description 39
- 230000004580 weight loss Effects 0.000 claims description 12
- 239000002246 antineoplastic agent Substances 0.000 claims description 10
- 231100000419 toxicity Toxicity 0.000 claims description 6
- 230000001988 toxicity Effects 0.000 claims description 6
- 229940034982 antineoplastic agent Drugs 0.000 claims description 5
- 229960003901 dacarbazine Drugs 0.000 claims description 4
- 239000002295 alkylating antineoplastic agent Substances 0.000 claims description 2
- 206010028980 Neoplasm Diseases 0.000 description 81
- 241001465754 Metazoa Species 0.000 description 26
- 230000037396 body weight Effects 0.000 description 22
- 239000003981 vehicle Substances 0.000 description 15
- 239000003814 drug Substances 0.000 description 13
- 210000004027 cell Anatomy 0.000 description 12
- 241000699670 Mus sp. Species 0.000 description 11
- 230000005764 inhibitory process Effects 0.000 description 10
- 229940079593 drug Drugs 0.000 description 9
- 238000005259 measurement Methods 0.000 description 9
- 230000000259 anti-tumor effect Effects 0.000 description 8
- 238000012360 testing method Methods 0.000 description 8
- 230000004614 tumor growth Effects 0.000 description 8
- 231100000331 toxic Toxicity 0.000 description 7
- 230000002588 toxic effect Effects 0.000 description 7
- 208000001382 Experimental Melanoma Diseases 0.000 description 6
- 238000002512 chemotherapy Methods 0.000 description 6
- 230000034994 death Effects 0.000 description 6
- 231100000517 death Toxicity 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 241000699666 Mus <mouse, genus> Species 0.000 description 5
- 150000001413 amino acids Chemical group 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 5
- 239000002953 phosphate buffered saline Substances 0.000 description 5
- 108090000765 processed proteins & peptides Proteins 0.000 description 5
- 229940044683 chemotherapy drug Drugs 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 208000000453 Skin Neoplasms Diseases 0.000 description 3
- 230000002238 attenuated effect Effects 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 201000011510 cancer Diseases 0.000 description 3
- 238000009169 immunotherapy Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 102000004196 processed proteins & peptides Human genes 0.000 description 3
- 201000000849 skin cancer Diseases 0.000 description 3
- 210000004881 tumor cell Anatomy 0.000 description 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 208000013641 Cerebrofacial arteriovenous metameric syndrome Diseases 0.000 description 2
- 229920002685 Polyoxyl 35CastorOil Polymers 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 230000036765 blood level Effects 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000011081 inoculation Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- QUANRIQJNFHVEU-UHFFFAOYSA-N oxirane;propane-1,2,3-triol Chemical compound C1CO1.OCC(O)CO QUANRIQJNFHVEU-UHFFFAOYSA-N 0.000 description 2
- 239000008389 polyethoxylated castor oil Substances 0.000 description 2
- 239000013641 positive control Substances 0.000 description 2
- 239000011550 stock solution Substances 0.000 description 2
- 238000007920 subcutaneous administration Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000002195 synergetic effect Effects 0.000 description 2
- 108700016958 thymosin fraction 5 Proteins 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 206010003497 Asphyxia Diseases 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- 206010027480 Metastatic malignant melanoma Diseases 0.000 description 1
- 238000011887 Necropsy Methods 0.000 description 1
- 241000283984 Rodentia Species 0.000 description 1
- 238000000692 Student's t-test Methods 0.000 description 1
- 238000009098 adjuvant therapy Methods 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 210000001099 axilla Anatomy 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 238000005119 centrifugation Methods 0.000 description 1
- 231100001157 chemotherapeutic toxicity Toxicity 0.000 description 1
- 238000011260 co-administration Methods 0.000 description 1
- 238000011284 combination treatment Methods 0.000 description 1
- 230000002301 combined effect Effects 0.000 description 1
- 229940127089 cytotoxic agent Drugs 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 229940000406 drug candidate Drugs 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000011888 foil Substances 0.000 description 1
- 239000002955 immunomodulating agent Substances 0.000 description 1
- 229940121354 immunomodulator Drugs 0.000 description 1
- 230000002584 immunomodulator Effects 0.000 description 1
- 230000003308 immunostimulating effect Effects 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 210000002752 melanocyte Anatomy 0.000 description 1
- 208000021039 metastatic melanoma Diseases 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000011815 naïve C57Bl6 mouse Methods 0.000 description 1
- 239000013642 negative control Substances 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 231100000272 reduced body weight Toxicity 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000000528 statistical test Methods 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
- 238000012414 sterilization procedure Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- LCJVIYPJPCBWKS-NXPQJCNCSA-N thymosin Chemical compound SC[C@@H](N)C(=O)N[C@H](CO)C(=O)N[C@H](CC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CC(O)=O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CO)C(=O)N[C@H](CO)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H]([C@@H](C)CC)C(=O)N[C@H]([C@H](C)O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CC(O)=O)C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@H](CCC(O)=O)C(O)=O LCJVIYPJPCBWKS-NXPQJCNCSA-N 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 239000002023 wood Substances 0.000 description 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/2292—Thymosin; Related peptides
-
- 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
- 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
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US1347607P | 2007-12-13 | 2007-12-13 | |
| PCT/US2008/086545 WO2009076587A1 (en) | 2007-12-13 | 2008-12-12 | Treatment of melanoma with alpha thymosin peptides in combination with a kinase inhibitor |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2011506473A true JP2011506473A (ja) | 2011-03-03 |
| JP2011506473A5 JP2011506473A5 (enExample) | 2012-02-02 |
Family
ID=40755899
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2010538181A Pending JP2011506473A (ja) | 2007-12-13 | 2008-12-12 | キナーゼ阻害剤と組み合わせられたアルファチモシンペプチドによる黒色腫の処置の方法 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20100267637A1 (enExample) |
| EP (1) | EP2240194A4 (enExample) |
| JP (1) | JP2011506473A (enExample) |
| CN (1) | CN101945664A (enExample) |
| AR (1) | AR069769A1 (enExample) |
| AU (1) | AU2008335025A1 (enExample) |
| CA (1) | CA2708229A1 (enExample) |
| WO (1) | WO2009076587A1 (enExample) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3943101A1 (en) * | 2014-10-21 | 2022-01-26 | SciClone Pharmaceuticals International Ltd. | Treatment of cancer with immune stimulator alpha thymosin peptide |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2604845A1 (de) * | 1976-02-07 | 1977-08-18 | Knoll Ag | Neue piperazinderivate |
| EP2633866A3 (en) * | 2003-10-17 | 2013-12-18 | Novo Nordisk A/S | Combination therapy |
| US20070292392A1 (en) * | 2006-06-15 | 2007-12-20 | Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. | Use of thymosin alpha 1 for preparing a medicament for the treatment of stage iv malignant melanoma |
-
2008
- 2008-12-12 CN CN2008801268138A patent/CN101945664A/zh active Pending
- 2008-12-12 AU AU2008335025A patent/AU2008335025A1/en not_active Abandoned
- 2008-12-12 JP JP2010538181A patent/JP2011506473A/ja active Pending
- 2008-12-12 US US12/747,438 patent/US20100267637A1/en not_active Abandoned
- 2008-12-12 WO PCT/US2008/086545 patent/WO2009076587A1/en not_active Ceased
- 2008-12-12 EP EP08858909A patent/EP2240194A4/en not_active Withdrawn
- 2008-12-12 CA CA2708229A patent/CA2708229A1/en not_active Abandoned
- 2008-12-15 AR ARP080105451A patent/AR069769A1/es not_active Application Discontinuation
Non-Patent Citations (4)
| Title |
|---|
| JPN5010016218; ＣＡＮＣＥＲ ＣＨＥＭＯＴＨＥＲ ＰＨＡＲＭＡＣＯＬ Ｖ６１ Ｎ４, 20071117, Ｐ５３５-５４８ * |
| JPN5010016219; ＡＮＮＡＬＳ ＯＦ ＯＮＣＯＬＯＧＹ Ｖ５ Ｎ８, 199410, Ｐ７４１-７４６ * |
| JPN6013045075; ＳｃｉＣｌｏｎｅ , 20061222 * |
| JPN6013045077; Ｉｎｔ ｊ Ｉｍｍｕｎｏｐｈａｒｍａｃｏｌ， ｖｏｌ．２２， ｐ．１０６７-１０７６ （２０００） * |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2708229A1 (en) | 2009-06-18 |
| AR069769A1 (es) | 2010-02-17 |
| US20100267637A1 (en) | 2010-10-21 |
| EP2240194A4 (en) | 2011-12-21 |
| CN101945664A (zh) | 2011-01-12 |
| AU2008335025A1 (en) | 2009-06-18 |
| EP2240194A1 (en) | 2010-10-20 |
| WO2009076587A1 (en) | 2009-06-18 |
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