David Ladkani;Natalia Ashtamker;Bracha Timan;Shlomo Bakshi
发明人:
David Ladkani,Natalia Ashtamker,Shlomo Bakshi,Bracha Timan
申请号：
US14800014
公开号：
US20160213633A1
申请日:
2015.07.15
申请国别(地区):
US
年份:
2016
代理人:
摘要：
The present invention provides methods of inducing anti-glatiramer acetate specific antibodies in a human subject afflicted with multiple sclerosis, comprising administration to the human subject of three subcutaneous injections of a 40 mg/ml dose of glatiramer acetate per week for at least 12 months, such that the level of anti-GA specific antibodies in the blood or serum of the human subject i) increases for up to about 6 months after an initial 40 mg/ml dose of glatiramer acetate of the administration is administered to the human subject； ii) increases at a greater rate during the first month after the initial 40 mg/ml dose of glatiramer acetate compared to the rate of increase after the first month to the third month after the initial 40 mg/ml dose of glatiramer acetate； iii) peaks at about 3 or about 6 months or between about 3 and about 6 months after the initial 40 mg/ml dose of glatiramer acetate； and iv) is higher than baseline at least about 12 months after the initial 40 mg/ml dose of glatiramer acetate, wherein the 40 mg/ml dose of glatiramer acetate is in a prefilled syringe containing 1 ml of an aqueous pharmaceutical solution of 40 mg/ml of glatiramer acetate and 40 mg/ml mannitol, and wherein the aqueous pharmaceutical solution has a pH in the range of 5.5 to 7.0.
