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Claims for Patent: 8,399,413

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Claims for Patent: 8,399,413

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:12/806,684
Patent Claims: 1. A method of reducing the frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and has MRI features consistent with multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to reduce the frequency of relapses in the patient.

2. The method of claim 1, further comprising reducing the mean cumulative number of Gd-enhancing lesions in the brain of the patient.

3. The method of claim 1, further comprising reducing the mean number of new T.sub.2 lesions in the brain of the patient.

4. The method of claim 1, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images.

5. The method of claim 1, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient.

6. The method of claim 1, wherein the patient has not received glatiramer acetate therapy prior to initiation of the subcutaneous injections.

7. 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.

8. The method of claim 2, further comprising reducing the mean number of new T.sub.2 lesions in the brain of the patient.

9. The method of claim 2, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images.

10. The method of claim 3, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images.

11. The method of claim 8, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images.

12. The method of claim 1, wherein the pharmaceutical composition has a pH in the range of 5.5 to 8.5.

13. The method of claim 12, wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0.

14. The method of claim 1, wherein the patient has at least 1 cerebral lesion detectable by an MRI scan and wherein the lesion is associated with brain tissue inflammation, myelin sheath damage or axonal damage.

15. The method of claim 14, wherein, the lesion is a demyelinating white matter lesion visible on brain MRI and wherein the white matter lesion is at least 3 mm in diameter.

16. The method of claim 1, wherein the patient has experienced a first clinical episode and wherein the first clinical episode includes a clinical episode of optic neuritis, blurring of vision, diplopia, involuntary rapid eye movement, blindness, loss of balance, tremors, ataxia, vertigo, clumsiness of a limb, lack of coordination, weakness of one or more extremity, altered muscle tone, muscle stiffness, spasms, tingling, paraesthesia, burning sensations, muscle pains, facial pain, trigeminal neuralgia, stabbing sharp pains, burning tingling pain, slowing of speech, slurring of words, changes in rhythm of speech, dysphagia, fatigue, bladder problems (including urgency, frequency, incomplete emptying and incontinence), bowel problems (including constipation and loss of bowel control), impotence, diminished sexual arousal, loss of sensation, sensitivity to heat, loss of short term memory, loss of concentration, or loss of judgment or reasoning.

17. The method of claim 16, wherein the patient has at least 1 cerebral lesion detectable by an MRI scan and wherein the lesion is associated with brain tissue inflammation, myelin sheath damage or axonal damage.

18. The method of claim 17, wherein, the lesion is a demyelinating white matter lesion visible on brain MRI and wherein the white matter lesion is at least 3 mm in diameter.

19. A method of reducing the frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient, wherein the pharmaceutical composition further comprises mannitol, and wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0, the regimen being sufficient to reduce the frequency of relapses in the patient.

20. A method of reducing the frequency of relapses in a human patient who has experienced a first clinical episode and has MRI features consistent with multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient, wherein the pharmaceutical composition further comprises mannitol, and wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0, the regimen being sufficient to reduce the frequency of relapses in the patient.
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