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
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Date
Authors
Derfuss, Tobias
Curtin, François
Guebelin, Claudia
Bridel, Claire
Rasenack, Maria
Matthey, Alain
Du Pasquier, Renaud
Schluep, Myriam
Desmeules, Jules
Lang, Alois B.
Journal Title
Journal ISSN
Volume Title
Publisher
Elsevier
Abstract
GNbAC1 is a humanized monoclonal antibody targeting MSRV-Env, an endogenous retroviral protein, which is
expressed inmultiple sclerosis (MS) lesions, is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation.
This paper describes the open-label extension up to 12 months of a trial testing GNbAC1 in 10 MS
patients at 2 and 6 mg/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.
Description
Keywords
Human endogenous retrovirus (HERV), Monoclonal antibody (MAb), Clinical trial, Safety, Multiple sclerosis (MS)
Sustainable Development Goals
Citation
Derfuss, T, Curtin, F, Guebelin, C, Bridel, C, Rasenack, M, Matthey, A, Du Pasquier, R, Schluep, M et al 2015, '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', Journal of Neuroimmunology, vol. 285, pp. 68-70.