Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS

Inclusion Criteria:

1. Male or female subjects diagnosed with PPMS; Diagnosis of PPMS consistent with theMcDonald Criteria (revisions of 2010).

2. Age between 18 and 65 years (inclusive).

3. Subjects diagnosed with PPMS for at least 1 year and with signs of diseaseprogression in the year prior to screening, in a rate of ≥ 1 point increase / yearin the EDSS score for EDSS between 2-5 and a rate of ≥0.5 point increase / year inthe EDSS scores > 5.

4. EDSS ≥2 and ≤ 6.5 (Pyramidal or Cerebellar FS ≥ 2).

5. Documented history or the presence at screening of > 1 oligoclonal band (OCB) ifquantitative testing was done, or OCB+ if not quantitative testing done and/orpositive IgG index in the cerebrospinal fluid (CSF).

6. Women of child bearing potential must have a negative urine pregnancy test atscreening and use an adequate contraceptive method throughout the study.

7. Ability to provide written informed consent.

Exclusion Criteria:

1. Subjects with RRMS, SPMS, or PRMS.

2. Subjects with a documented history of clinical relapse events.

3. Any relevant medical, surgical, or psychiatric condition, laboratory value, orconcomitant medication which, in the opinion of the investigator, makes the subjectunsuitable for study entry or potentially unable to complete all aspects of thestudy.

4. Contraindications or inability to successfully undergo magnetic resonance imaging (MRI) scanning.

5. Subjects diagnosed with any other than MS systemic autoimmune disease that mayimpact the CNS with MS like lesions such as Sarcoidosis, Sjögren's syndrome,Systemic Lupus Erythematosus (SLE), Lyme disease, APLA syndrome, etc.. Subjects withstable local/organ autoimmune disease such as psoriasis, Cutaneous Lupuserythematosus, thyroiditis (Hashimoto, grave) etc. may be considered eligible uponthe PI's discretion.

6. Severe anemia (hemoglobin <10 g/dL).

7. Abnormal renal function (serum creatinine >1.5xULN or creatinine clearance <30ml/min).

8. Abnormal liver function (transaminases >2xULN).

9. Pregnant or breast-feeding women.

10. Treatment with any kind of steroids during the last month prior to screening visit.

11. History of any anaphylactic reaction and/or serious allergic reaction following avaccination, a known hypersensitivity to any component of the study drug, e.g.glatiramer acetate (GA), polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA).

12. Known or suspected history of drug or alcohol abuse.

13. Known as positive for HIV, hepatitis, VDRL, or tuberculosis.

14. Active malignant disease of any kind. However, a patient, who had a malignantdisease in the past, was treated and is currently disease - free for at least 7years, may be considered eligible, upon the PI and sponsor's discretion.

15. Previous treatment with B-cell-targeting therapies (e.g. rituximab, ocrelizumab,atacicept, belimumab or ofatumumab) within 6 months prior to screening visit.

16. Previous treatment with cladribine within 2 years prior to screening visit

17. Previous treatment with azathioprine, mitoxantrone or methotrexate within 6 monthsprior to screening visit.

18. Previous treatment with lymphocyte-trafficking modifiers (e.g. natalizumab,fingolimod) within 6 months prior to screening visit. Subjects should have a totallymphocyte count within normal range.

19. Previous treatment with beta interferons, intravenous immunoglobulin, plasmapheresiswithin 2 months prior to screening visit.

20. Previous treatment with any glatiramer acetate therapy within 3 months prior toscreening visit.

21. Uncontrolled diabetes.

22. Participation in an investigational study drug within 30 days prior to study entry.