US20220031699A1 - Methods of treating myeloproliferative disorders - Google Patents

Methods of treating myeloproliferative disorders Download PDF

Info

Publication number
US20220031699A1
US20220031699A1 US17/279,765 US201917279765A US2022031699A1 US 20220031699 A1 US20220031699 A1 US 20220031699A1 US 201917279765 A US201917279765 A US 201917279765A US 2022031699 A1 US2022031699 A1 US 2022031699A1
Authority
US
United States
Prior art keywords
thiamine
patient
compound
myelofibrosis
administered
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US17/279,765
Other languages
English (en)
Inventor
Tymara Berry
John Hood
Catriona Jamieson
Curtis L. Scribner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Impact Biomedicines Inc
Original Assignee
Impact Biomedicines Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=69950867&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20220031699(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Impact Biomedicines Inc filed Critical Impact Biomedicines Inc
Priority to US17/279,765 priority Critical patent/US20220031699A1/en
Assigned to IMPACT BIOMEDICINES, INC. reassignment IMPACT BIOMEDICINES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CELGENE CORPORATION
Assigned to IMPACT BIOMEDICINES, INC. reassignment IMPACT BIOMEDICINES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: JAMIESON, CATRIONA, HOOD, JOHN, SCRIBNER, Curtis L.
Assigned to CELGENE CORPORATION reassignment CELGENE CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BERRY, Tymara
Publication of US20220031699A1 publication Critical patent/US20220031699A1/en
Abandoned legal-status Critical Current

Links

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
    • A61K31/495—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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • 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

Definitions

  • the cognitive assessment occurs during the 2 nd 28-day cycle. In some embodiments, the cognitive assessment occurs during the 3 rd 28-day cycle. In some embodiments, the cognitive assessment occurs during at least every 3 rd 28-day cycle. In some embodiments, the cognitive assessment comprises a mini-mental state examination. In some embodiments, the method further comprises analyzing thiamine level in the patient.
  • thiamine equivalent refers to an agent that delivers or is capable of delivering a bioequivalent amount of thiamine.
  • Such thiamine equivalents include prodrugs of thiamine as well as derivatives of thiamine such as thiamine monophosphate, thiamine pyrophosphate (also known as thiamine diphosphate), and thiamine triphosphate.
  • a thiamine equivalent is a dietary form of thiamine such as that found in vegetables or other food sources.
  • unit dosage form refers to a physically discrete unit of inventive formulation appropriate for the subject to be treated. It will be understood, however, that the total daily usage of the compositions of the present invention will be decided by the attending physician within the scope of sound medical judgment.
  • the specific effective dose level for any particular subject or organism will depend upon a variety of factors including the disorder being treated and the severity of the disorder; activity of specific active agent employed; specific composition employed; age, body weight, general health, sex and diet of the subject; time of administration, and rate of excretion of the specific active agent employed; duration of the treatment; drugs and/or additional therapies used in combination or coincidental with specific compound(s) employed, and like factors well known in the medical arts.
  • the disease is characterized by clonal myeloproliferation, ineffective erythropoiesis, bone marrow stromal changes, hepatosplenic extramedullary hematopoiesis, and aberrant cytokine expression (Tefferi A, Pardanani A. JAK inhibitors in myeloproliferative neoplasms: rationale, current data and perspective. Blood Rev. 2011 September; 25(5):229-37). Patients typically present with splenomegaly, constitutional symptoms, moderate to severe anemia, thrombocytopenia, and leukocytosis.
  • Compound I is administered in the form of a dihydrochloride monohydrate (e.g., Compound II).
  • provided methods comprise administering Compound I, or a pharmaceutically acceptable salt or hydrate thereof, (e.g., Compound II), once daily to the patient for two or more 28-day cycles, wherein the patient's thiamine levels are assessed at the beginning of every 28-day cycle.
  • provided methods comprise administering Compound I, or a pharmaceutically acceptable salt or hydrate thereof, (e.g., Compound II), once daily to the patient for two or more 28-day cycles, wherein the patient's thiamine levels are assessed at the end of each 28-day cycle.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
US17/279,765 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders Abandoned US20220031699A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US17/279,765 US20220031699A1 (en) 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862736369P 2018-09-25 2018-09-25
US201862783076P 2018-12-20 2018-12-20
PCT/US2019/052608 WO2020068755A1 (en) 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders
US17/279,765 US20220031699A1 (en) 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/052608 A-371-Of-International WO2020068755A1 (en) 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US17/560,373 Continuation US11400092B2 (en) 2018-09-25 2021-12-23 Methods of treating myeloproliferative disorders

Publications (1)

Publication Number Publication Date
US20220031699A1 true US20220031699A1 (en) 2022-02-03

Family

ID=69950867

Family Applications (2)

Application Number Title Priority Date Filing Date
US17/279,765 Abandoned US20220031699A1 (en) 2018-09-25 2019-09-24 Methods of treating myeloproliferative disorders
US17/560,373 Active US11400092B2 (en) 2018-09-25 2021-12-23 Methods of treating myeloproliferative disorders

Family Applications After (1)

Application Number Title Priority Date Filing Date
US17/560,373 Active US11400092B2 (en) 2018-09-25 2021-12-23 Methods of treating myeloproliferative disorders

Country Status (14)

Country Link
US (2) US20220031699A1 (https=)
EP (1) EP3856169A4 (https=)
JP (2) JP2022502492A (https=)
KR (2) KR20210102192A (https=)
CN (1) CN113286584A (https=)
AU (1) AU2019346521B2 (https=)
BR (1) BR112021005518A2 (https=)
CL (1) CL2021000744A1 (https=)
IL (1) IL281736A (https=)
MA (1) MA53741A (https=)
MX (2) MX2021003450A (https=)
MY (1) MY209349A (https=)
SG (1) SG11202103019WA (https=)
WO (1) WO2020068755A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400092B2 (en) 2018-09-25 2022-08-02 Impact Biomedicines, Inc. Methods of treating myeloproliferative disorders

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3856189A4 (en) * 2018-09-25 2022-06-29 Impact Biomedicines, Inc. Methods of treating myeloproliferative disorders
EP3923948A4 (en) 2019-02-12 2022-11-16 Impact Biomedicines, Inc. CRYSTALLINE SHAPES OF A JAK2 INHIBITOR
JP2024501640A (ja) * 2020-12-16 2024-01-15 インパクト バイオメディシンズ インコーポレイテッド フェドラチニブの投薬
MX2023009858A (es) 2021-02-25 2023-09-12 Impact Biomedicines Inc Uso de inhibidores de proteina de bromodominio y motivo extraterminal (bet) solo o en combinacion con fedratinib o ruxolitinib como tratamiento para una malignidad hematologica tal como la mielofibrosis.
WO2023044297A1 (en) 2021-09-14 2023-03-23 Impact Biomedicines, Inc. Fedratinib for treating myeloproliferative disorders

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090093009A1 (en) * 2007-10-09 2009-04-09 Sum Chan Mass spectrometry method for measuring thiamine in body fluid

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103626742B (zh) * 2005-11-01 2017-04-26 塔格根公司 激酶的联-芳基间-嘧啶抑制剂
US8133900B2 (en) 2005-11-01 2012-03-13 Targegen, Inc. Use of bi-aryl meta-pyrimidine inhibitors of kinases
CA2816957A1 (en) 2010-11-07 2012-05-10 Targegen, Inc. Compositions and methods for treating myelofibrosis
US20130102624A1 (en) * 2011-05-19 2013-04-25 John V. Schloss Early detection of thiamine deficiency
US10155987B2 (en) 2012-06-12 2018-12-18 Dana-Farber Cancer Institute, Inc. Methods of predicting resistance to JAK inhibitor therapy
WO2015081127A2 (en) 2013-11-26 2015-06-04 Gilead Sciences, Inc. Therapies for treating myeloproliferative disorders
CA2936865A1 (en) * 2014-01-31 2015-08-06 Dana-Farber Cancer Institute, Inc. Diaminopyrimidine benzenesulfone derivatives and uses thereof
HK1256638A1 (zh) * 2015-08-04 2019-09-27 Acceleron Pharma Inc. 用於治疗骨髓增生性病症的方法
WO2020068755A1 (en) 2018-09-25 2020-04-02 Impact Biomedicines, Inc. Methods of treating myeloproliferative disorders
EP3856189A4 (en) 2018-09-25 2022-06-29 Impact Biomedicines, Inc. Methods of treating myeloproliferative disorders
FR3092581A1 (fr) 2019-02-12 2020-08-14 Impact Biomedicines, Inc Formes cristallines d'un inhibiteur de jak2
EP3923948A4 (en) 2019-02-12 2022-11-16 Impact Biomedicines, Inc. CRYSTALLINE SHAPES OF A JAK2 INHIBITOR

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090093009A1 (en) * 2007-10-09 2009-04-09 Sum Chan Mass spectrometry method for measuring thiamine in body fluid

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Cleveland Heartlab. "Vitamin B1 (Thiamine), Plasma/Serum, LC/MS/MS," October 20, 2015. accessed from: https://www.clevelandheartlab.com/tests/vitamin-b1-thiamine-plasma-serum-lc-ms-ms/ (Year: 2015) *
Shi, Jack G., et al. "The Effect of CYP3A4 Inhibition or Induction on the Pharmacokinetics and Pharmacodynamics of Orally Administered Ruxolitinib (INCB018424 Phosphate) in Healthy Volunteers." The Journal of Clinical Pharmacology, vol. 52, no. 6, June 2012, pp. 809–18. (Year: 2012) *
Steinberg, Amir, et al. "Thiamine Deficiency in Stem Cell Transplant Patients: A Case Series With an Accompanying Review of the Literature." Clinical Lymphoma Myeloma and Leukemia, vol. 14, Sept. 2014, pp. S111–13. DOI.org (Crossref), https://doi.org/10.1016/j.clml.2014.06.009. (Year: 2014) *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400092B2 (en) 2018-09-25 2022-08-02 Impact Biomedicines, Inc. Methods of treating myeloproliferative disorders

Also Published As

Publication number Publication date
AU2019346521B2 (en) 2025-05-08
JP2022502492A (ja) 2022-01-11
WO2020068755A1 (en) 2020-04-02
AU2019346521A1 (en) 2021-05-20
MY209349A (en) 2025-07-03
CN113286584A (zh) 2021-08-20
BR112021005518A2 (pt) 2021-06-29
US11400092B2 (en) 2022-08-02
KR20250164332A (ko) 2025-11-24
US20220133724A1 (en) 2022-05-05
MX2023013844A (es) 2023-12-08
CL2021000744A1 (es) 2021-10-08
MX2021003450A (es) 2021-07-16
EP3856169A4 (en) 2022-06-29
EP3856169A1 (en) 2021-08-04
KR20210102192A (ko) 2021-08-19
JP2024161416A (ja) 2024-11-19
MA53741A (fr) 2021-08-04
SG11202103019WA (en) 2021-04-29
IL281736A (en) 2021-05-31

Similar Documents

Publication Publication Date Title
US11400092B2 (en) Methods of treating myeloproliferative disorders
US11198731B2 (en) Combinations of cabozantinib and atezolizumab to treat cancer
Pemmaraju et al. A phase I/II study of the Janus kinase (JAK) 1 and 2 inhibitor ruxolitinib in patients with relapsed or refractory acute myeloid leukemia
Verstovsek Ruxolitinib: an oral Janus kinase 1 and Janus kinase 2 inhibitor in the management of myelofibrosis
Mao et al. Palbociclib in advanced acral melanoma with genetic aberrations in the cyclin-dependent kinase 4 pathway
US20220133751A1 (en) Methods of treating myeloproliferative disorders
EP2922827A2 (en) Methods of treating a disease or disorder associated with bruton's tyrosine kinase
CN119403557A (zh) 用于治疗癌症的menin-mll抑制剂
US12012383B2 (en) Compositions and methods for inhibiting dihydroorotate dehydrogenase
TW202342047A (zh) 使用經取代之嘧啶-4(3h)-酮及索托拉西布(sotorasib)之組合療法
KR20160090814A (ko) Jak, cdk 및 pim의 억제제를 포함하는 조합 요법
EA021951B1 (ru) Противораковая комбинация
CN113730572A (zh) 含有抗egfr抗体或其片段的联合用药物
EA051859B1 (ru) Способы лечения миелопролиферативных расстройств
HK40049559A (en) Methods of treating myeloproliferative disorders
WO2013059548A1 (en) Compositions and methods for treating cancer using jak2 inhibitor
EP4504202B1 (en) Combination therapies comprising gdc-6036 and gdc-0077 for the treatment of cancer
EA048287B1 (ru) Способы лечения миелопролиферативных расстройств
Giannandrea et al. Focus on the Management of Reporting for Drug Ineffectiveness
Jabbour Chronic myelod leukemia–what Else is there Beyond Protein Kinase Inhibitors?
HK40118757A (zh) 用於治疗癌症的包含gdc-6036和gdc-0077的组合疗法
WO2022268075A1 (zh) 化合物在制备用于治疗骨髓纤维化及其相关症状/体征的药物中的应用、该化合物的用途
Rolfo et al. Adverse event management in anaplastic lymphoma kinase-positive non-small cell lung cancer
HK1193045B (en) Combination of panobinostat and ruxolitinib in the treatment of cancer such as a myeloproliferative neoplasm

Legal Events

Date Code Title Description
AS Assignment

Owner name: CELGENE CORPORATION, NEW JERSEY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BERRY, TYMARA;REEL/FRAME:057457/0727

Effective date: 20200101

Owner name: IMPACT BIOMEDICINES, INC., NEW JERSEY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CELGENE CORPORATION;REEL/FRAME:057457/0799

Effective date: 20200211

Owner name: IMPACT BIOMEDICINES, INC., NEW JERSEY

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HOOD, JOHN;JAMIESON, CATRIONA;SCRIBNER, CURTIS L.;SIGNING DATES FROM 20200107 TO 20200312;REEL/FRAME:057457/0749

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION