HRP20230504T1 - Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma - Google Patents
Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma Download PDFInfo
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- HRP20230504T1 HRP20230504T1 HRP20230504TT HRP20230504T HRP20230504T1 HR P20230504 T1 HRP20230504 T1 HR P20230504T1 HR P20230504T T HRP20230504T T HR P20230504TT HR P20230504 T HRP20230504 T HR P20230504T HR P20230504 T1 HRP20230504 T1 HR P20230504T1
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- 201000003793 Myelodysplastic syndrome Diseases 0.000 title claims 3
- 239000005557 antagonist Substances 0.000 title 1
- 239000003112 inhibitor Substances 0.000 claims 41
- 230000011664 signaling Effects 0.000 claims 41
- 210000003924 normoblast Anatomy 0.000 claims 13
- 125000003275 alpha amino acid group Chemical group 0.000 claims 12
- 102000001554 Hemoglobins Human genes 0.000 claims 11
- 108010054147 Hemoglobins Proteins 0.000 claims 11
- 230000007774 longterm Effects 0.000 claims 6
- 239000012634 fragment Substances 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 229920001184 polypeptide Polymers 0.000 claims 4
- 102000004196 processed proteins & peptides Human genes 0.000 claims 4
- 108090000765 processed proteins & peptides Proteins 0.000 claims 4
- 101100437153 Rattus norvegicus Acvr2b gene Proteins 0.000 claims 2
- 210000003743 erythrocyte Anatomy 0.000 claims 2
- 230000002489 hematologic effect Effects 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 102000005606 Activins Human genes 0.000 claims 1
- 108010059616 Activins Proteins 0.000 claims 1
- 239000000488 activin Substances 0.000 claims 1
- 238000004820 blood count Methods 0.000 claims 1
- 238000005534 hematocrit Methods 0.000 claims 1
- 238000010606 normalization Methods 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
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- 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
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
- A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- General Health & Medical Sciences (AREA)
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- Biomedical Technology (AREA)
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- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
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- Animal Behavior & Ethology (AREA)
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- Ecology (AREA)
- Genetics & Genomics (AREA)
- Urology & Nephrology (AREA)
- Food Science & Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (18)
1. Inhibitor signalizacije receptora aktivina tipa II (ActRII) za upotrebu u postupku liječenja mijelodisplastičnih sindroma (MDS) kod subjekta, pri čemu postupak obuhvaća:
(a) određivanje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti; i
(b) davanje subjektu farmaceutski učinkovite doze inhibitora signalizacije ActRII između 0,1 mg/kg i 2,0 mg/kg, ako je najmanje 15%, 16%, 17%, 18%, 19% ili 20% od eritroblasta kod subjekta prstenasti sideroblasti,
pri čemu je navedeni inhibitor signalizacije ActRII polipeptid koji sadrži:
(i) aminokiselinsku sekvencu koja je najmanje 90% identična sa SEQ ID NO:7;
(ii) aminokiselinsku sekvencu koja je najmanje 95% identična sa SEQ ID NO:7;
(iii) aminokiselinsku sekvencu koja je najmanje 98% identična sa SEQ ID NO:7;
(iv) aminokiselinsku sekvencu SEQ ID NO:7;
(v) aminokiselinsku sekvencu koja je najmanje 90% identična sa SEQ ID NO:25;
(vi) aminokiselinsku sekvencu koja je najmanje 95% identična sa SEQ ID NO:25;
(vii) aminokiselinsku sekvencu koja je najmanje 98% identična sa SEQ ID NO:25;
(viii) aminokiselinsku sekvencu SEQ ID NO:25; ili
(ix) fragment izvanstanične domene ActRIIB, pri čemu se fragment sastoji od aminokiselinske sekvence SEQ ID NO:23; poveznice; i Fc od IgG.
2. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1, naznačen time što se postupkom postiže:
(a) dugoročno smanjenje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti u usporedbi s početnim postotkom eritroblasta kod subjekta koji su prstenasti sideroblasti, pri čemu dugoročno smanjenje je smanjenje postotka eritroblasta koje se održava najmanje 1, 2, 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII; i/ili
(b) dugotrajno povećanje razine hemoglobina kod subjekta u usporedbi s početnom razinom hemoglobina kod subjekta, pri čemu je početna razina hemoglobina kod subjekta razina hemoglobina kod subjekta u vremenskom razdoblju prije davanja subjektu početne dozu inhibitora signalizacije ActRII; pri čemu dugoročno povećanje je povećanje razine hemoglobina koje se održava najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon vremenskog razdoblja primjene inhibitora signalizacije ActRII.
3. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što se inhibitor signalizacije ActRII primjenjuje u kratkom vremenskom periodu, i pri čemu je kratki vremenski period 1, 2, 3, 4 ili 5 mjeseci.
4. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što postupak nadalje obuhvaća:
(c) određivanje drugog postotka eritroblasta kod subjekta koji su prstenasti sideroblasti nakon određenog vremenskog razdoblja, izborno pri čemu je vremenski period 1, 2, 3, 4, 5 ili 6 mjeseci; i
(d) izborno davanje subjektu prilagođene doze inhibitora signalizacije ActRII.
5. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što postupak nadalje obuhvaća:
(c) određivanje razine hemoglobina kod subjekta nakon što je subjektu primijenjen inhibitor signalizacije ActRII, izborno pri čemu se razina hemoglobina određuje unutar 6, 12, 18 i/ili 24 mjeseca nakon što je primijenjen inhibitor signalizacije ActRII; i
(d) prekid primjene inhibitora signalizacije ActRII subjektu, ako je razina hemoglobina kod subjekta najmanje 11 g/dL.
6. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1, naznačen time što se postotak eritroblasta kod subjekta koji su prstenasti sideroblasti određuje unutar 1 dana, 2 dana, 3 dana, 4 dana, 5 dana, 6 dana, 1 tjedna, 2 tjedana, 3 tjedna, 4 tjedna, 5 tjedana, 6 tjedana, 7 tjedana, 8 tjedana, 3 mjeseca, 4 mjeseca, 5 mjeseci ili 6 mjeseci davanja subjektu farmaceutski učinkovite doze inhibitora signalizacije ActRII.
7. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 2, naznačen time što je dugoročno smanjenje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti najmanje 1,5, 2,5, 5,0, 7,5 ili 10,0 puta ispod početnog postotka eritroblasta kod subjekta koji su prstenasti sideroblasti najmanje 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
8. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 2, naznačen time što je dugotrajno povećanje razine hemoglobina kod subjekta razina hemoglobina između oko 11 g/dL i 18 g/dL kod subjekta tijekom najmanje 3, 4 , 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
9. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 3, naznačen time što
(i) prvi postotak eritroblasta koji su prstenasti sideroblasti kod subjekta kojemu je primijenjen inhibitor signalizacije ActRII tijekom kratkog vremenskog razdoblja smanjen je na manje od 10%, 9%, 8%, 7%, 6%, 5%, 4 %, 3%, 2% ili manje od 1% tijekom najmanje 6, 12, 18 ili 24 mjeseca nakon kratkog vremenskog razdoblja primjene inhibitora signalizacije ActRII; i/ili
(ii) razina hemoglobina kod subjekta kojem je primijenjen inhibitor signalizacije ActRII u kratkom vremenskom razdoblju je između oko 11 g/dL i 18 g/dL tijekom najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
10. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 9, naznačen time što subjekt ima povećanu vjerojatnost postizanja normalizacije jednog ili više hematoloških parametara, ako je najmanje 15%, 16%, 17%, 18%, 19 % ili 20% eritroblasta kod subjekta, prstenasti sideroblasti u usporedbi sa subjektom koji ima najviše 15% eritroblasta koji su prstenasti sideroblasti.
11. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 10, naznačen time što je hematološki parametar razina hemoglobina, hematokrit, broj crvenih krvnih stanica ili postotak eritroblasta kod subjekta koji su prstenasti sideroblasti.
12. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 11, naznačen time što kod subjekta nije potrebna transfuzija crvenih krvnih stanica najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon vremenskog razdoblja primjene inhibitora signalizacije ActRII.
13. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 12, naznačen time što se inhibitor signalizacije ActRII primjenjuje:
(i) jednom svaka tri tjedna;
(ii) jednom svakih 28 dana; ili
(iii) jednom svaka 42 dana.
14. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 13, naznačen time što se inhibitor signalizacije ActRII primjenjuje putem injekcije, po izboru pri čemu je injekcija potkožna.
15. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži aminokiselinsku sekvencu SEQ ID NO:25.
16. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži aminokiselinsku sekvencu SEQ ID NO:7.
17. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži fragment izvanstanične domene od ActRIIB, pri čemu se fragment sadrži aminokiselinsku sekvencu SEQ ID NO:23; poveznicu; i Fc od IgG.
18. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 17, pri čemu je subjekt čovjek.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462086977P | 2014-12-03 | 2014-12-03 | |
| US201462088478P | 2014-12-05 | 2014-12-05 | |
| US201562153872P | 2015-04-28 | 2015-04-28 | |
| US201562173782P | 2015-06-10 | 2015-06-10 | |
| US201562218728P | 2015-09-15 | 2015-09-15 | |
| EP15865213.1A EP3227675B1 (en) | 2014-12-03 | 2015-12-03 | Activin-actrii antagonists and uses for treating myelodysplastic syndrome |
| PCT/US2015/063595 WO2016090077A1 (en) | 2014-12-03 | 2015-12-03 | Activin-actrii antagonists and uses for treating anemia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230504T1 true HRP20230504T1 (hr) | 2023-09-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230504TT HRP20230504T1 (hr) | 2014-12-03 | 2015-12-03 | Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US11471510B2 (hr) |
| EP (2) | EP4233889A3 (hr) |
| JP (2) | JP2018501307A (hr) |
| KR (1) | KR102556991B1 (hr) |
| CN (2) | CN114675039A (hr) |
| AU (2) | AU2015358469B2 (hr) |
| BR (1) | BR112017011722A2 (hr) |
| CA (1) | CA2969572A1 (hr) |
| CY (1) | CY1126033T1 (hr) |
| DK (1) | DK3227675T3 (hr) |
| ES (1) | ES2946160T3 (hr) |
| FI (1) | FI3227675T3 (hr) |
| HK (2) | HK1245397A1 (hr) |
| HR (1) | HRP20230504T1 (hr) |
| HU (1) | HUE062189T2 (hr) |
| IL (1) | IL252631B1 (hr) |
| LT (1) | LT3227675T (hr) |
| MD (1) | MD4801C1 (hr) |
| PL (1) | PL3227675T3 (hr) |
| PT (1) | PT3227675T (hr) |
| RS (1) | RS64214B1 (hr) |
| SI (1) | SI3227675T1 (hr) |
| TW (2) | TWI730949B (hr) |
| WO (1) | WO2016090077A1 (hr) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8216997B2 (en) | 2008-08-14 | 2012-07-10 | Acceleron Pharma, Inc. | Methods for increasing red blood cell levels and treating anemia using a combination of GDF traps and erythropoietin receptor activators |
| CA2890217C (en) | 2012-11-02 | 2021-07-20 | Yifu FANG | Activin-actrii antagonists and uses for treating bone and other disorders |
| MA41052A (fr) | 2014-10-09 | 2017-08-15 | Celgene Corp | Traitement d'une maladie cardiovasculaire à l'aide de pièges de ligands d'actrii |
| BR112017011722A2 (pt) | 2014-12-03 | 2018-02-27 | Acceleron Pharma Inc | antagonistas de activina-actrii e usos para o tratamento de anemia |
| MA41119A (fr) | 2014-12-03 | 2017-10-10 | Acceleron Pharma Inc | Méthodes de traitement de syndromes myélodysplasiques et d'anémie sidéroblastique |
| PL3286206T3 (pl) | 2015-04-22 | 2021-09-13 | Biogen Ma Inc. | Nowe hybrydowe białka pułapki na ligand actriib do leczenia chorób powodujących zanik mięśni |
| JP2018522579A (ja) | 2015-05-20 | 2018-08-16 | セルジーン コーポレイション | アクチビンＩＩ型受容体リガンドトラップを使用するβ−サラセミアのインビトロ細胞培養法 |
| EP3370754A4 (en) | 2015-11-04 | 2019-10-23 | Acceleron Pharma Inc. | METHODS FOR INCREASING ERYTHROCYTE RATES AND TREATING INEFFECTIVE ERYTHROPOISIS |
| KR20180096645A (ko) | 2015-11-23 | 2018-08-29 | 악셀레론 파마 인코포레이티드 | 눈 질환의 치료 방법 |
| WO2018022982A1 (en) * | 2016-07-29 | 2018-02-01 | Trustees Of Boston University | Age-associated clonal hematopoiesis accelerates cardio-metabolic disease development |
| WO2018089706A2 (en) | 2016-11-10 | 2018-05-17 | Keros Therapeutics, Inc. | Activin receptor type iia variants and methods of use thereof |
| EP3638243A4 (en) | 2017-06-14 | 2021-03-17 | Celgene Corporation | METHOD OF TREATMENT OF MYELOPROLIFERATIVE NEOPLASM ASSOCIATED MYELOFIBROSIS AND ANEMIA |
| JP7258021B2 (ja) | 2017-11-09 | 2023-04-14 | ケロス セラピューティクス インコーポレイテッド | アクチビンＩＩａ型受容体変異体を含む医薬組成物 |
| AU2019206634A1 (en) | 2018-01-12 | 2020-07-23 | Keros Therapeutics, Inc. | Activin receptor type IIB variants and methods of use thereof |
| WO2019213016A1 (en) * | 2018-04-30 | 2019-11-07 | The Children's Hospital Of Philadelphia | Methods of improving anemias by combining agents |
| US20210346464A1 (en) * | 2018-10-31 | 2021-11-11 | Celgene Corporation | TREATMENT OF ANEMIA DUE TO VERY LOW, LOW, OR INTERMEDIATE RISK MYELODYSPLASTIC SYNDROMES IN SUBJECTS WITH RING SIDEROBLASTS USING ACTIVIN-ACTRll LIGAND TRAPS |
| WO2021189010A1 (en) * | 2020-03-20 | 2021-09-23 | Keros Therapeutics, Inc. | Methods of using activin receptor type iib variants |
| WO2021189006A1 (en) * | 2020-03-20 | 2021-09-23 | Keros Therapeutics, Inc. | Methods of using activin receptor type iia variants |
| US20230270821A1 (en) * | 2020-11-06 | 2023-08-31 | Acceleron Pharma Inc. | Formulations comprising actrii polypeptide variants |
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| EP3131931B1 (en) | 2014-04-18 | 2020-10-21 | Acceleron Pharma Inc. | Methods for increasing red blood cell levels and treating sickle-cell disease |
| WO2015192111A1 (en) | 2014-06-13 | 2015-12-17 | Acceleron Pharma, Inc. | Methods and compositions for treating ulcers |
| MA41052A (fr) | 2014-10-09 | 2017-08-15 | Celgene Corp | Traitement d'une maladie cardiovasculaire à l'aide de pièges de ligands d'actrii |
| BR112017011722A2 (pt) | 2014-12-03 | 2018-02-27 | Acceleron Pharma Inc | antagonistas de activina-actrii e usos para o tratamento de anemia |
| MA41119A (fr) | 2014-12-03 | 2017-10-10 | Acceleron Pharma Inc | Méthodes de traitement de syndromes myélodysplasiques et d'anémie sidéroblastique |
| EP3294320A4 (en) | 2015-05-13 | 2018-12-26 | Celgene Corporation | Treatment of beta-thalassemia using actrii ligand traps |
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| CN108348578B (zh) | 2015-08-04 | 2022-08-09 | 阿塞勒隆制药公司 | 用于治疗骨髓增生性病症的方法 |
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| EP3490582A4 (en) | 2016-07-27 | 2020-04-01 | Acceleron Pharma Inc. | METHOD AND COMPOSITIONS FOR TREATING MYELOFIBROSE |
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| US20210346464A1 (en) | 2018-10-31 | 2021-11-11 | Celgene Corporation | TREATMENT OF ANEMIA DUE TO VERY LOW, LOW, OR INTERMEDIATE RISK MYELODYSPLASTIC SYNDROMES IN SUBJECTS WITH RING SIDEROBLASTS USING ACTIVIN-ACTRll LIGAND TRAPS |
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