	US 12,370,233 B2
	Depot systems comprising glatiramer acetate
Ehud Marom, Tel Aviv (IL); Nadav Bleich Kimelman, Tel Aviv (IL); Uri Danon, Tel Aviv (IL); and Shai Rubnov, Tel Aviv (IL)
Assigned to MAPI PHARMA LTD., Ness Ziona (IL)
Appl. No. 16/328,582
Filed by MAPI PHARMA LTD., Ness Ziona (IL)
PCT Filed Aug. 9, 2017, PCT No. PCT/IL2017/050882 § 371(c)(1), (2) Date Feb. 26, 2019, PCT Pub. No. WO2018/042415, PCT Pub. Date Mar. 8, 2018.
Claims priority of provisional application 62/381,598, filed on Aug. 31, 2016.
Prior Publication US 2021/0283209 A1, Sep. 16, 2021
Int. Cl. A61K 38/02 (2006.01); A61K 9/00 (2006.01); A61K 47/32 (2006.01); A61K 47/36 (2006.01); A61K 47/59 (2017.01)

CPC A61K 38/02 (2013.01) [A61K 9/0024 (2013.01); A61K 47/32 (2013.01); A61K 47/36 (2013.01); A61K 47/593 (2017.08)]

12 Claims

1. A method of alleviating at least one symptom of relapsing-remitting multiple sclerosis (RRMS) in a human patient suffering from RRMS or a human 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 patient a therapeutically effective regimen of a single intramuscular injection of a depot formulation comprising 40 mg dose of glatiramer acetate (GA) encapsulated with a poly(lactic-co-glycolic acid) (PLGA) at a weight ratio of about 1:11.5 once every 4 weeks, the regimen being sufficient to alleviate the at least one symptom of the patient, wherein the symptom is selected from the group consisting of the frequency of relapses, the number of enhancing lesions or the number of new lesions images of brain Magnetic Resonance Imaging (MRI), and the Expanded Disability Status Scale (EDSS) score of the patient.