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Claims for Patent: 9,155,776

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Claims for Patent: 9,155,776

Title:Low frequency glatiramer acetate therapy
Abstract: A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.
Inventor(s): Klinger; Ety (Tel Aviv, IL)
Assignee: Yeda Research & Development Co., Ltd. (Rehovot, IL)
Application Number:14/720,556
Patent Claims: 1. A method of treating a human patient suffering from a relapsing form of multiple sclerosis, while inducing reduced severity of injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily, the method consisting of one subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate on only each of three days during each week of treatment with at least one day without a subcutaneous injection of the pharmaceutical composition between each day on which there is a subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5 to 7.0, so as to thereby treat the human patient with reduced severity of injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

2. The method of claim 1, which induces reduced frequency and severity of immediate post injection reactions and injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.

3. The method of claim 1, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

4. The method of claim 2, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

5. A method for reducing the frequency of relapses by 30% or more as compared to placebo in a human population, for reducing brain atrophy, for reducing the cumulative number of enhancing lesions on T1-weighted images, or for reducing the level of disability as measured by EDSS Score of a human patient suffering from a relapsing form of multiple sclerosis, while inducing reduced severity of injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily, which method consists of one subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate on only each of three days during each week of treatment with at least one day without a subcutaneous injection of the pharmaceutical composition between each day on which there is a subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5 to 7.0, so as to thereby reduce the frequency of relapses by 30% or more as compared to placebo in a human population, reduce brain atrophy, reduce the cumulative number of enhancing lesions on T1-weighted images, or reduce the level of disability as measured by EDSS Score of the human patient with reduced severity of injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

6. The method of claim 5, which reduces brain atrophy and for reducing the frequency of relapses by 30% or more as compared to placebo in a human population.

7. The method of claim 5, which reduces the cumulative number of enhancing lesions on T1-weighted images.

8. The method of claim 5, which reduces the level of disability of the human patient as measured by EDSS Score.

9. The method of claim 5, which induces reduced frequency and severity of immediate post injection reactions and injection site reactions in the human patient relative to administration of 20 mg of glatiramer acetate s.c. daily.

10. The method of claim 5, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

11. The method of claim 9, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

12. A method for improving the tolerability of glatiramer acetate treatment of a human patient suffering from a relapsing form of multiple sclerosis which is as effective as administration of 20 mg of glatiramer acetate s.c. daily, which method consists of one subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate on only each of three days during each week of treatment with at least one day without a subcutaneous injection of the pharmaceutical composition between each day on which there is a subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5 to 7.0, so as to thereby treat the human patient as effectively as by administration of 20 mg of glatiramer acetate s.c. daily, and with reduced severity of injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

13. The method of claim 12, which treats the human patient with reduced frequency and severity of immediate post injection reactions and injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

14. The method of claim 12, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

15. The method of claim 14, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

16. A method for improving the tolerability of glatiramer acetate therapy reducing the frequency of relapses, reducing brain atrophy, reducing the cumulative number of enhancing lesions on T1-weighted images, or reducing the level of disability as measured by EDSS Score, of a human patient suffering from a relapsing form of multiple sclerosis as effectively as administration of 20 mg of glatiramer acetate s.c. daily, which method consists of one subcutaneous injection of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate on only each of three days during each week of treatment with at least one day without a subcutaneous injection of the pharmaceutical composition between each day on which there is a subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe, and wherein the pharmaceutical composition further comprises mannitol and has a pH in the range 5.5 to 7.0, so as to thereby reduce the frequency of relapses, reduce brain atrophy, reduce the cumulative number of enhancing lesions on T1-weighted images, or reduce the level of disability as measured by EDSS Score, of the human patient as effectively as by administration of 20 mg of glatiramer acetate s.c. daily, and with reduced severity of injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

17. The method of claim 16, which reduces the frequency of relapses as effectively as administration of 20 mg of glatiramer acetate s.c. daily.

18. The method of claim 17, which reduces brain atrophy as effectively as administration of 20 mg of glatiramer acetate s.c. daily.

19. The method of claim 18, which reduces the cumulative number of enhancing lesions on T1-weighted images as effectively as administration of 20 mg of glatiramer acetate s.c. daily.

20. The method of claim 19, which reduces the level of disability as measured by EDSS Score as effectively as administration of 20 mg of glatiramer acetate s.c. daily.

21. The method of claim 17, which treats the human patient with reduced frequency and severity of immediate post injection reactions and injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

22. The method of claim 18, which treats the human patient with reduced frequency and severity of immediate post injection reactions and injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

23. The method of claim 19, which treats the human patient with reduced frequency and severity of immediate post injection reactions and injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

24. The method of claim 20, which treats the human patient with reduced frequency and severity of immediate post injection reactions and injection site reactions relative to administration of 20 mg of glatiramer acetate s.c. daily.

25. The method of claim 17, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

26. The method of claim 18, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

27. The method of claim 19, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

28. The method of claim 21, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

29. The method of claim 22, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.

30. The method of claim 23, wherein the human patient has not received glatiramer acetate therapy prior to initiation of the treatment.
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