Claims for Patent: 12,171,778

Summary for Patent: 12,171,778

Title:	Methods of treating myelodysplastic syndrome
Abstract:	This disclosure provides methods of treating a myelodysplastic syndrome (MDS) in a subject that is naive to treatment with an agent selected from a hypomethylating agent (HMA) and lenalidomide, or both. The method includes administering to the subject an effective amount of a telomerase inhibitor, such as e.g. imetelstat or imetelstat sodium. In some cases, the subject treated is classified as low or intermediate-1 IPSS risk MDS and/or have MDS relapsed/refractory to Erythropoiesis-Stimulating Agent (ESA).
Inventor(s):	Aleksandra Rizo, Jacqueline Cirillo Bussolari
Assignee:	Geron Corp
Application Number:	US16/047,502
Patent Claims:	1. A method of treating a myelodysplastic syndrome (MDS) in a subject, the method comprising: classifying the subject as being naïve to treatment with an agent selected from a hypomethylating agent (HMA), lenalidomide, and combination thereof; selecting the subject for treatment with a telomerase inhibitor because the subject has been classified as being naive to treatment with the agent; and administering an effective amount of the telomerase inhibitor to the subject to treat the myelodysplastic syndrome. 2. The method of claim 1, wherein the MDS is relapsed or refractory MDS. 3. The method of claim 2, wherein the MDS is MDS relapsed or refractory to an erythropoiesis-stimulating agent (ESA). 4. The method of claim 1, wherein the subject is classified as a low or intermediate-1 IPSS risk MDS subject. 5. The method of claim 1, wherein the subject is transfusion dependent. 6. The method of claim 5, wherein the transfusion dependent subject has a transfusion requirement of about 4 units or more during the 8 weeks prior to the administration of the telomerase inhibitor. 7. The method of claim 1, wherein the subject is a non-del5q human patient. 8. The method of claim 1, wherein the subject is classified as a low or intermediate-1 IPSS risk MDS subject and is non-del5q. 9. The method of claim 1, wherein the subject is naive to treatment with lenalidomide. 10. The method of claim 1, wherein the subject is naive to treatment with a hypomethylating agent (HMA). 11. The method of claim 1, wherein the subject is naive to treatment with lenalidomide and to a hypomethylating agent (HMA). 12. The method of claim 10, wherein the HMA is decitabine. 13. The method of claim 10, wherein the HMA is azacitidine. 14. The method of claim 1, wherein the telomerase inhibitor is imetelstat. 15. The method of claim 14, wherein the imetelstat is imetelstat sodium. 16. The method of claim 14, wherein the telomerase inhibitor is imetelstat and is administered for 1, 2, 3, 4, 5, 6, 7, 8 or more than 8 dosage cycles, each cycle comprising: (a) intravenous administration of about 7-10 mg/kg imetelstat once every four weeks; (b) intravenous administration of about 7-10 mg/kg imetelstat once weekly for four weeks; (c) intravenous administration of about 2.5-10 mg/kg imetelstat once every three weeks; or (d) intravenous administration of about 0.5-9.4 mg/kg imetelstat once every four weeks. 17. The method of claim 16, wherein each dosage cycle comprises intravenous administration of about 7-10 mg/kg imetelstat once every four weeks. 18. The method of claim 17, wherein each dosage cycle comprises intravenous administration of about 7.5 mg/kg imetelstat once every four weeks. 19. The method of claim 1, wherein the MDS is relapsed or refractory MDS and wherein the subject is classified as a low or intermediate-1 IPSS risk MDS subject. 20. The method of claim 14, wherein the subject is transfusion dependent. 21. The method of claim 14, wherein the subject is a non-del5q human patient. 22. A method of treating a myelodysplastic syndrome (MDS) in a subject, the method comprising: classifying the subject as being a non-del5q human subject; selecting the subject for treatment with a telomerase inhibitor because the subject has been classified as being a non-del5q human subject; and administering an effective amount of the telomerase inhibitor to the subject to treat the myelodysplastic syndrome. 23. The method according to claim 22, wherein the MDS is relapsed or refractory MDS. 24. The method according to claim 23, wherein the MDS is MDS relapsed or refractory to an erythropoiesis-stimulating agent (ESA). 25. The method according to claim 22, wherein the subject is classified as a low or intermediate-1 IPSS risk MDS subject. 26. The method according to claim 22, wherein the subject is transfusion dependent. 27. The method according claim 26, wherein the transfusion dependent subject has a transfusion requirement of about 4 units or more during the 8 weeks prior to the administration of the telomerase inhibitor. 28. The method of claim 23, wherein the subject is naive to treatment with lenalidomide. 29. The method of claim 23, wherein the subject is naive to treatment with a hypomethylating agent (HMA). 30. The method of claim 23, wherein the subject is naive to treatment with lenalidomide and to a hypomethylating agent (HMA). 31. The method of claim 29, wherein the HMA is decitabine. 32. The method of claim 29, wherein the HMA is azacitidine. 33. The method according to claim 23, wherein the telomerase inhibitor is imetelstat. 34. The method according to claim 33, wherein the imetelstat is imetelstat sodium. 35. The method according to claim 33, wherein the MDS is relapsed or refractory MDS and wherein the subject is classified as a low or intermediate-1 IPSS risk MDS subject. 36. The method according to claim 33, wherein the subject is transfusion dependent. 37. The method according to claim 33, wherein the telomerase inhibitor is imetelstat wherein the use comprises administration for 1, 2, 3, 4, 5, 6, 7, 8 or more than 8 dosage cycles, each cycle comprising: (a) intravenous administration of about 7-10 mg/kg imetelstat once every four weeks; (b) intravenous administration of about 7-10 mg/kg imetelstat once weekly for four weeks; (c) intravenous administration of about 2.5-10 mg/kg imetelstat once every three weeks; or (d) intravenous administration of about 0.5-9.4 mg/kg imetelstat once every four weeks. 38. The method according to claim 37, wherein each dosage cycle comprises intravenous administration of about 7-10 mg/kg imetelstat once every four weeks. 39. The method according to claim 38, wherein each dosage cycle comprises intravenous administration of about 7.5 mg/kg imetelstat once every four weeks.