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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Authors

Derfuss, Tobias
Curtin, François
Guebelin, Claudia
Bridel, Claire
Rasenack, Maria
Matthey, Alain
Du Pasquier, Renaud
Schluep, Myriam
Desmeules, Jules
Lang, Alois B.

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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.

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Keywords

Human endogenous retrovirus (HERV), Monoclonal antibody (MAb), Clinical trial, Safety, Multiple sclerosis (MS)

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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.