Claims for Patent: 11,400,092

Summary for Patent: 11,400,092

Title:	Methods of treating myeloproliferative disorders
Abstract:	The present disclosure provides methods of mitigating thiamine deficiency.
Inventor(s):	Berry; Tymara (Morristown, NJ), Hood; John (Del Mar, CA), Jamieson; Catriona (La Jolla, CA), Scribner; Curtis L. (Oakland, CA)
Assignee:	Impact Biomedicines, Inc. (Summit, NJ)
Application Number:	17/560,373
Patent Claims:	1. A method for treating a patient comprising: administering to the patient Compound I ##STR00003## or a pharmaceutically acceptable salt and/or hydrate thereof; (ii) monitoring thiamine level in the patient; and (iii) administering to the patient thiamine or a thiamine equivalent if the patient's thiamine level is below a reference standard, wherein the reference standard is from about 74 to about 222 nM/L of whole blood wherein the patient has a myeloproliferative disorder. 2. The method of claim 1, wherein the patient's thiamine level is monitored by analyzing one or more biomarkers for thiamine deficiency. 3. The method of claim 1, wherein thiamine is administered to the patient at an amount of about 100 mg per day. 4. The method of claim 1, wherein thiamine is administered to the patient at an amount of about 250 mg to about 500 mg. 5. The method of claim 4, wherein thiamine is administered to the patient at an amount of about 250 mg. 6. The method of claim 4, wherein thiamine is administered to the patient at an amount of about 500 mg. 7. The method of claim 1, wherein thiamine is administered intravenously. 8. The method of claim 1, wherein thiamine is administered according to the following schedule: about 500 mg TID for 2 or 3 days; about 250 mg to about 500 mg daily (QD) for 3-5 days; and about 100 mg QD for 90 days. 9. The method of claim 1, wherein the patient is administered a thiamine equivalent sufficient to deliver about 100 mg of thiamine mg per day. 10. The method of claim 1, wherein thiamine or a thiamine equivalent is administered orally. 11. The method of claim 1, wherein the patient is administered a thiamine equivalent sufficient to deliver about 250 mg to about 500 mg of thiamine. 12. The method of claim 11, wherein the thiamine equivalent is sufficient to deliver about 250 mg of thiamine. 13. The method of claim 11, wherein the thiamine equivalent is sufficient to deliver about 500 mg of thiamine. 14. The method of claim 11, wherein the thiamine equivalent is sufficient to deliver an amount of thiamine according to the following schedule: about 500 mg TID for 2 or 3 days; about 250 mg to about 500 mg daily (QD) for 3-5 days; and about 100 mg QD for 90 days. 15. The method of claim 1, further comprising increasing the patient's magnesium level. 16. The method of claim 1, wherein the myeloproliferative disorder is myelofibrosis. 17. The method of claim 16, wherein the myelofibrosis is primary myelofibrosis. 18. The method of claim 17, wherein the primary myelofibrosis is selected from intermediate risk primary myelofibrosis and high risk primary myelofibrosis. 19. The method of claim 16, wherein the myelofibrosis is secondary myelofibrosis. 20. The method of claim 16, wherein the myelofibrosis is post essential thrombocythemia myelofibrosis. 21. The method of claim 16, wherein the myelofibrosis is post polycythemia vera myelofibrosis. 22. The method of claim 1, wherein the myeloproliferative disorder is acute myeloid leukemia (AML). 23. The method of claim 1, wherein the myeloproliferative disorder is polycythemia vera. 24. The method of claim 1, wherein the myeloproliferative disorder is essential thrombocythemia. 25. The method of claim 1, wherein Compound I is in the form of a dihydrochloride monohydrate salt.