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Claims for Patent: 8,969,302

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Claims for Patent: 8,969,302

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:13/770,677
Patent Claims: 1. A method of treatment of a human patient suffering from a relapsing form of multiple sclerosis comprising administration to the human patient of three subcutaneous injections of a 40 mg/ml dose of glatiramer acetate per week so as to treat the human patient.

2. The method of claim 1, wherein the human patient is suffering from relapsing-remitting multiple sclerosis.

3. The method of claim 1, wherein the human patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis.

4. The method of claim 2, wherein the three subcutaneous injections are on three days each week selected from the group consisting of day 1, day 3 and day 5; day 1, day 3 and day 6; day 1, day 4 and day 6; day 2, day 4 and day 6; day 2, day 4 and day 7; 2, day 5 and day 7; and day 3, day 5 and day 7.

5. The method of claim 3, wherein the three subcutaneous injections are on three days every week selected from the group consisting of day 1, day 3 and day 5; day 1, day 3 and day 6; day 1, day 4 and day 6; day 2, day 4 and day 6; day 2, day 4 and day 7; 2, day 5 and day 7; and day 3, day 5 and day 7.

6. The method of claim 2, wherein the glatiramer acetate is present in 1 ml of a pharmaceutical composition in a prefilled syringe for self administration by the human patient.

7. The method of claim 3, wherein the glatiramer acetate is present in 1 ml of a pharmaceutical composition in a prefilled syringe for self administration by the human patient.

8. The method of claim 6, wherein the pharmaceutical composition further comprises mannitol and has a pH in the range of 5.5 to 7.0.

9. The method of claim 7, wherein the pharmaceutical composition further comprises mannitol and has a pH in the range of 5.5 to 7.0.

10. A method of treatment of a human patient suffering from a relapsing form of multiple sclerosis comprising subcutaneous injection by the human patient of a 40 mg/ml dose of glatiramer acetate three times per week with at least one day between every subcutaneous injection, wherein the glatiramer acetate is present in 1 ml of a pharmaceutical composition in a prefilled syringe for self injection by the human patient, and wherein the pharmaceutical composition further comprises mannitol and has a pH in the range of 5.5 to 7.0.

11. The method of claim 10, wherein each subcutaneous injection is on day 1, day 3 and day 5; day 1, day 3 and day 6; day 1, day 4 and day 6; day 2, day 4 and day 6; day 2, day 4 and day 7; 2, day 5 and day 7; or day 3, day 5 and day 7 every week.

12. The method of claim 10, wherein the human patient is suffering from relapsing-remitting multiple sclerosis.
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