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1. WO2009010107 - USE OF EPO RECEPTOR ACTIVATION OR STIMULATION FOR THE IMPROVEMENT OF THE EDSS SCORE IN PATIENTS WITH MULTIPLE SCLEROSIS

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Patent Claims

1. Method for the improvement of the expanded disability- status scale (EDSS) score achieved by mammals affected by multiple sclerosis, wherein a substance effecting increased and/or prolonged activation and/or
stimulation of the erythropoietin receptor is applied to the mammal .

2. Method according to the preceding claim, characterized in that a erythropoietin receptor activator or
stimulator with or without hematopoietic/
erythropoietic activity is applied to the mammal as substance effecting increase and/or prolonged
activation and/or stimulation of the erythropoietin- receptor .

3. Method according to one of the preceding claims,
characterized in that at least one of the following substances: erythropoietin ( e.g. a native
erythropoietin or recombinant erythropoietin) , a
derivative thereof,
a variant thereof, a fusion protein thereof, an
analogue thereof, an effective fragment thereof, a
mimetics thereof, an erythropoietin agonist, a
synthetic erythropoiesis stimulating protein, an
erythropoietin stabilizing substance, an
erythropoietin receptor activating and/or stimulating antibody and a substance genetically modifying the mammal in order to increase erythropoietin expression is applied to the mammal as substance effecting
increase and/or prolonged activation and/or
stimulation of the erythropoietin-receptor.

4. Method according to one of the preceding claims,
characterised in that the substance is applied in
intervals which are interrupted by application-free periods of time in which said substance is not
applied.

5. Method according to the preceding claim, characterised in that the application of the substance is effected intermittently in at least two application periods
with a duration of respectively at least two weeks, application-free periods with a duration of at least two weeks in which said substance is not applied being provided between two application periods.

6. Method according to one of claims 4 and 5,
characterised in that an application period lasts 12 to 48 weeks, advantageously 18 to 36 weeks,
advantageously 24 to 28 weeks.

7. Method according to one of claims 4 to 6,
characterised in that an application- free period lasts 8 to 53 weeks, advantageously 16 to 28 weeks.

8. Method according to one of claims 4 to 7,
characterised in that at least one of the application periods comprises two partial periods, said substance being applied weekly in a first partial period and said substance being applied every two weeks in a
subsequent second partial period.

9. Method according to one of the preceding claims,
characterised in that said substance is given in a
dose or an equivalent to a dose of 1,000 IU to 200,000 IU, advantageously 5,000 IU to 100,000 IU,
advantageously 30000 IU to 60000 IU, advantageously
40000 IU to 50000 IU per week, per application and/or per application time or doses equivalent to said doses leading to comparable erythropoietin levels or
comparable erythropoietin receptor activating
biological activity, said international unit being
international units of native or recombinant
erythropoietin .

10. Method according to one of the preceding claims,
characterised in that the application is effected
parenterally/systemically.

11. Method according to one of the preceding claims,
characterised in that the application is effected
vascularly, intranasally and/or by inhalation.

12. Method according to one of the preceding claims,
characterised in that the application is effected
intravenously, subcutaneousIy and/or intramuscularly.

13. Method according to one of the preceding claims,
characterised in that the mammal is a human.

14. Use of a substance effecting increased and/or
prolonged activation and/or stimulation of the
erythropoietin receptor for the production of a drug for the improvement of the expanded disability status scale (EDSS) score achieved by mammals affected by multiple sclerosis.

15. Use according to claim 14 of an erythropoietin
receptor activator or stimulator with or without
hematopoietic / erythropoietic activity as substance effecting increase and/or prolonged activation and/or stimulation of the erythropoietin-receptor .

16 Use according to one of claims 14 and 15 of at least one of the following substances: erythropoietin (e.g. a native erythropoietin or recombinant
erythropoietin) , a derivative thereof,
a variant thereof, a fusion protein thereof, an
analogue thereof, an effective fragment thereof, a mimetics thereof, an erythropoietin agonist, a
synthetic erythropoiesis stimulating protein, an
erythropoietin stabilizing substance, an
erythropoietin receptor activating and/or stimulating antibody and a substance genetically modifying the mammal in order to increase erythropoietin expression as substance effecting increase and/or prolonged
stimulation of the erythropoietin-receptor.

17. Use according to one of claims 14 to 16 for the
production of a drug for intermittent treatment for improvement of the expanded disability status scale (EDSS) score achieved by mammals affected by multiple sclerosis.

18. Use according to claim 17, characterised in that the substance effecting increase and/or prolonged
activation and/or stimulation of the erythropoietin- receptor is applied in intervals for intermittent
treatment, said intervals being interrupted by
application-free periods of time in which said
substance is not applied.

19. Use according to one of the claims 17 and 18,
characterised in that the substance effecting
increased and/or prolonged activation and/or
stimulation of the erythropoietin-receptor is applied intermittently in at least two application periods with a duration of respectively at least two weeks, application-free periods with a duration of at least two weeks in which said substance effecting increased and/or prolonged activation and/or stimulation of the erythropoietin-receptor is not applied being provided between two application periods.

20. Use according to one of claims 18 and 19,
characterised in that an application period lasts 12 to 48 weeks, advantageously 18 to 36 weeks,
advantageously 24 to 28 weeks.

21. Use according to one of claims 18 to 20, characterised in that an application-free period lasts 8 to 53
weeks, advantageously 16 to 28 weeks.

22. Use according to one of claims 18 to 21, characterised in that at least one of the application periods
comprises two partial periods, said substance being applied weekly in a first partial period and said
substance being applied every two weeks in a
subsequent second partial period.

23. Use according to one of the claims 14 to 22,
characterised in that the said substance is given in a dose or an equivalent to a dose of 1,000 IU to 200,000 IU, advantageously 5,000 IU to 100,000 IU,
advantageously 30000 IU to 60000 IU per week, per
application and/or per application period, said
international units being international units of
native or recombinant erythropoietin.

24. Use according to one of the claims 14 to 23,
characterised in that the application is effected
parenterally/systemically .

25. Use according to one of the claims 14 to 24,
characterised in that the application is effected
vascularly, intranasally and/or by inhalation.

26. Use according to one of claims 14 to 25, characterised in that the application is effected intravenously,
subcutaneously and/or intramuscularly.

27. Use according to one of the claims 14 to 26,
characterised in that the mammal is a human.