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Claims for Patent: 8,232,250

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Claims for Patent: 8,232,250

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:13/308,299
Patent Claims: 1. 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 a therapeutically effective regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to alleviate the symptom of the patient.

2. The method of claim 1, wherein alleviating a symptom comprises reducing the frequency of relapses.

3. The method of claim wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the human patient.

4. The method of claim 1, wherein alleviating a symptom comprises reducing the mean cumulative number of Gd-enhancing lesions, reducing the mean number of new T.sub.2 lesions, reducing the total volume of T.sub.2 lesions, or reducing the cumulative number of enhancing lesions on T.sub.1-weighted images in the brain of the patient.

5. The method of claim 1, wherein alleviating a symptom comprises reducing brain atrophy in the patient.

6. The method of claim 1, wherein alleviating a symptom comprises increasing the time to a confirmed relapse in the patient.

7. The method of claim 1, wherein alleviating a symptom comprises reducing the total number of confirmed relapses in the patient.

8. The method of claim 1, wherein alleviating a symptom comprises reducing the progression of MRI-monitored disease activity in the patient.

9. The method of claim 1, wherein alleviating a symptom comprises reducing the number of new hypointense lesions on enhanced T.sub.1 scans in the patient or reducing the total volume of hypointense lesions on enhanced T.sub.1 scans in the patient.

10. The method of claim 1, wherein alleviating a symptom comprises reducing a level of disability as measured by EDSS Score, by the work productivity and activities impairment-General Health (WPAI-GH) questionnaire, or by EuroQoL (EQ5D) questionnaire in the patient.

11. The method of claim 1, wherein alleviating a symptom comprises reducing a change in EDSS Score in the patient or reducing a change in Ambulation Index in the patient.

12. The method of claim 1, wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the patient.

13. The method of claim 1, wherein the patient has not received glatiramer acetate therapy prior to initiation of the regimen.

14. The method of claim 1, wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate.

15. A method of increasing the tolerability of GA treatment 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 which comprises reducing frequency of subcutaneous injections from daily subcutaneous injections of a pharmaceutical composition comprising a 20 mg dose of glatiramer acetate to a regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every injection, wherein the regimen is therapeutically effective, so as to thereby increase the tolerability of GA treatment in the patient.

16. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an immediate post injection reaction.

17. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an injection site reaction.

18. The method of claim 15, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient.

19. A method of reducing frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis comprising administering to the human patient a therapeutically effective regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to reduce frequency of relapses in the human patient.

20. The method of claim 19, wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the human patient.
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