Protected by US Patents
Pre-clinical studies and evaluation of treatment need of glatiramer acetate depot
ECTRIMS Online Library.
Bleich-Kimelman N.
Oct 8, 2015; 115168
Abstract
Discussion Forum (0)
Rate & Comment (0)
Abstract: EP1320
Type: e-Poster
Abstract Category: Immunomodulation / Immunosuppression
Background: Glatiramer Acetate (GA) is the active pharmaceutical ingredient in Copaxone®, prescribed for treatment of relapsing remitting multiple sclerosis (RRMS). GA Depot is a long-acting formulation of GA intended for intramuscular (IM) injection once every 28 days. It is expected that GA Depot will significantly increase compliance of GA users and therefore will provide a therapeutic benefit.
Aims:
(1) to compare GA Depot activity to that of Copaxone®.
(2) to assess the unmet need for such formulation among current Copaxone® users.
Methods: GA Depot was evaluated in vitro for GA release profile. In vivo, GA Depot effect on clinical manifestations of EAE was compared to that of Copaxone®, using three EAE studies in C57BL/6 mice in which single IM dose of GA Depot was compared repeated daily subcutaneously doses of Copaxone®. Additionally, we conducted a Helsinki/IRB approved questioner study among RRMS patients that are treated with Copaxone® for at least 12 months in order to assess the clinical need for GA Depot.
Results: In vitro, GA Depot was found to release GA for 28 days in a constant rate. In vivo, EAE studies demonstrated that GA Depot effect on disease burden and symptoms is at least comparable to that of Copaxone®. In the questioner study, over 70% of subjects expressed:
(a) increased satisfaction if frequency of injections would be reduced from once daily to once monthly, and
(b) willingness to switch to IM GA Depot although it may cause increased injection site adverse events.
Conclusions: Experimental in vitro and in vivo data suggests that GA Depot has a potential beneficial effect in RRMS. Moreover, there is a clear unmet need for such treatment among Copaxone® treated RRMS patients. An open-labelled phase IIa clinical study is being conducted in Israel to test the safety, tolerability and efficacy of GA Depot.
Disclosure:
Nadav Bleich Kimelman: Mapi-pharma employee
Shai Rubnov: Mapi-pharma employee
Uri Danon: Mapi-pharma employee
Ehud Marom: Mapi-pharma employee
Ariel Miller: Consultant to Mapi-Pharma
Type: e-Poster
Abstract Category: Immunomodulation / Immunosuppression
Background: Glatiramer Acetate (GA) is the active pharmaceutical ingredient in Copaxone®, prescribed for treatment of relapsing remitting multiple sclerosis (RRMS). GA Depot is a long-acting formulation of GA intended for intramuscular (IM) injection once every 28 days. It is expected that GA Depot will significantly increase compliance of GA users and therefore will provide a therapeutic benefit.
Aims:
(1) to compare GA Depot activity to that of Copaxone®.
(2) to assess the unmet need for such formulation among current Copaxone® users.
Methods: GA Depot was evaluated in vitro for GA release profile. In vivo, GA Depot effect on clinical manifestations of EAE was compared to that of Copaxone®, using three EAE studies in C57BL/6 mice in which single IM dose of GA Depot was compared repeated daily subcutaneously doses of Copaxone®. Additionally, we conducted a Helsinki/IRB approved questioner study among RRMS patients that are treated with Copaxone® for at least 12 months in order to assess the clinical need for GA Depot.
Results: In vitro, GA Depot was found to release GA for 28 days in a constant rate. In vivo, EAE studies demonstrated that GA Depot effect on disease burden and symptoms is at least comparable to that of Copaxone®. In the questioner study, over 70% of subjects expressed:
(a) increased satisfaction if frequency of injections would be reduced from once daily to once monthly, and
(b) willingness to switch to IM GA Depot although it may cause increased injection site adverse events.
Conclusions: Experimental in vitro and in vivo data suggests that GA Depot has a potential beneficial effect in RRMS. Moreover, there is a clear unmet need for such treatment among Copaxone® treated RRMS patients. An open-labelled phase IIa clinical study is being conducted in Israel to test the safety, tolerability and efficacy of GA Depot.
Disclosure:
Nadav Bleich Kimelman: Mapi-pharma employee
Shai Rubnov: Mapi-pharma employee
Uri Danon: Mapi-pharma employee
Ehud Marom: Mapi-pharma employee
Ariel Miller: Consultant to Mapi-Pharma
Code of conduct/disclaimer available in General Terms & Conditions