US20220031699A1 - Methods of treating myeloproliferative disorders - Google Patents
Methods of treating myeloproliferative disorders Download PDFInfo
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- 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
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- thiamine
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- myelofibrosis
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- A61P35/02—Antineoplastic agents specific for leukemia
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- 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.
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AU2021401681A1 (en) | 2020-12-16 | 2023-06-22 | Impact Biomedicines, Inc. | Dosing of fedratinib |
EP4297750A1 (en) | 2021-02-25 | 2024-01-03 | Impact Biomedicines, Inc. | Use of a bet inhibitor alone or in combination with fedratinib or ruxolitinib for treating a hematological malignancy such as myelofibrosis |
WO2023044297A1 (en) | 2021-09-14 | 2023-03-23 | Impact Biomedicines, Inc. | Fedratinib for treating myeloproliferative disorders |
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AU2019346521A1 (en) | 2021-05-20 |
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