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A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients - a twelve month follow-up
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
ID
4378947
Author(s)
Derfuss, T.; Curtin, F.; Guebelin, C.; Bridel, C.; Rasenack, M.; Matthey, A.; Du Pasquier, R.; Schluep, M.; Desmeules, J.; Lang, A. B.; Perron, H.; Faucard, R.; Porchet, H.; Hartung, H. P.; Kappos, L.; Lalive, P. H.
A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients - a twelve month follow-up
GNbAC1 is a humanized monoclonal antibody targeting MSRV-Env, an endogenous retroviral protein, which is expressed in multiple sclerosis (MS) lesions, is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation. This paper describes the open-label extension up to 12months of a trial testing GNbAC1 in 10 MS patients at 2 and 6mg/kg. The primary objective was to assess GNbAC1 safety, and other objectives were pharmacokinetic and pharmacodynamic assessments. During the extended study, no safety issues occurred in the 8 remaining patients. No anti-GNbAC1 antibodies were detected. GNbAC1 appears well tolerated.
