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Claims for Patent: 6,987,103

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Claims for Patent: 6,987,103

Title:Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Abstract: The present invention concerns a method of treating chronic myelogenous leukemia, a related myeloproliferative disorder or a Ph-positive acute lymphocytic leukemia in a subject animal, comprising: (a) selecting or identifying an animal suffering from chronic myelogenous leukemia or a related myeloproliferative disorder and showing resistance or intolerance to treatment with STI571; and (b) administering to the animal homoharringtonine. In a preferred embodiment, the animal is a human being.
Inventor(s): Robin; Jean-Pierre (Charlottesville, VA), Mahon; Francois-Xavier (Bordeaux, FR), Maisonneuve; Herve (La Roche sur Yon, FR), Maloisel; Frederick (Illkirch Graffenstaden, FR), Blanchard; Julie (Rouillon, FR)
Assignee: Stragen Pharma S.A. (Geneva, CH)
Application Number:10/397,267
Patent Claims: 1. A method of treating chronic myelogenous leukemia, a related myeloproliferative disorder or a Ph-positive acute lymphocytic leukemia in a subject animal, comprising: (a) selecting or identifying an animal suffering from chronic myelogenous leukemia or a related myeloproliferative disorder and showing resistance or intolerance to treatment with STI571; and (b) administering to the animal homoharringtonine.

2. The method of claim 1, wherein homoharringtonine is combined with one or more other antileukemic agents.

3. The method of claim 1, wherein homoharringtonine is combined simultaneously with one or more other antileukemic agents.

4. The method of claim 1, wherein homoharringtonine is combined sequentially with one or more other antileukemic agents.

5. The method of treatment of claim 1, wherein homoharringtonine is combined sequentially by addition to existing STI571 therapy, comprising the following steps (a) to (d), and optionally (e): (a) administering to patients with chronic myelogenous leukemia, optionally further resistant to standard interferon alpha therapy, STI571 until a complete cytogenetic response or at least a complete hematologic response is obtained; (b) in patients partially STI571-resistant, reducing to 300 to 400 mg daily but not removing STI571 treatment, in those patients who failed to have or lost their complete cytogenetic or hematologic response; (c) administering homoharringtonine subcutaneously and/or intravenously or/and orally, at a dose of 0.25 to 5 mg/m.sup.2; (d) adjusting the homoharringtonine dose and/or STI571 dose according to cytopenia and/or side effects; and (e) optionally, subcutaneously or intravenously administering an oral nucleoside synergistic with homoharringtonine, wherein said oral nucleoside may be added simultaneously or sequentially to homoharringtonine.

6. The method of claim 5, wherein said oral nucleoside in step (e) is cytarabine, wherein cytarabine may be added simultaneously or sequentially to homoharringtonine.

7. A method for inhibiting proliferation of a hyperproliferative myeloid cell resistant to STI5171, comprising: a) contacting the cell with STI571; and b) contacting the cell with homoharringtonine, wherein STI571 and homoharringtonine are provided in an amount effective to inhibit proliferation of said myeloid cell.

8. A method of treating chronic myelogenous leukemia, a related myeloproliferative disorder or a Ph-positive acute lymphocytic leukemia in a subject animal, comprising: a) administering to the animal in a first course of treatment STI571, wherein said CML or disorder displays resistance and/or intolerance to STI571; and b) administering to the animal in a second course of treatment a combination of homoharringtonine and STI571 in an amount effective to inhibit proliferation of myeloid cells.

9. The method of treatment of claim 2, wherein the other antileukemic agents are interferon alpha and/or one or more nucleosides and/or a farnesyl transferase inhibitor (FTI).

10. The method of treatment of claim 4, wherein the other antileukemic agent is interferon alpha or PEG-interferon.

11. The method of treatment of claim 4, wherein the other antileukemic agent is one or more nucleosides.

12. The method of treatment of claim 9, wherein the other antileukemic agents is a farnesyl transferase inhibitor (FTI).

13. The method of treatment of claim 11, wherein the nucleosides are cytarabine (Ara-C) and/or decitabine and/or troxacytabine.

14. The method of treatment of claim 13, wherein a nucleoside is cytarabine (Ara-C).

15. The method of treatment of claim 9, wherein the other agents are a combination of interferon alpha and cytarabine.

16. The method of treatment of claim 1, wherein the animal is a human being.

17. The method of claim 2, wherein homoharringtonine is combined with STI571.

18. The method of claim 3, wherein homoharringtonine is combined simultaneously with STI571.

19. The method of claim 3, wherein homoharringtonine is combined simultaneously with STI571 which is continued from previous treatment.

20. The method of claim 4, wherein homoharringtonine is combined sequentially with STI571.

21. The method of treatment of claim 20, wherein administration of the ST1571 is continued.

22. The method of treatment of claim 5, wherein the STI571 is administered in a dosage of 400 to 800 mg daily.

23. The method of treatment of claim 5, wherein the homoharringtonine is administered at a dose of 2.5 mg.sup.2.

24. The method of treatment of claim 5, wherein the homoharringtonine is administered for 2 to 14 days per 28-day cycle.

25. The method of treatment of claim 8, wherein the animal is a human being.
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