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Title

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

Authors
Derfuss, Tobias
Guebelin, Claudia
Rasenack, Maria
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Published in Journal of Neuroimmunology. 2015, vol. 285, p. 68-70
Abstract 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.
Keywords AgedAntibodiesMonoclonalHumanized/pharmacology/therapeutic useCohort StudiesEndogenous Retroviruses/drug effects/immunologyFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple Sclerosis/drug therapy/immunologyViral Envelope Proteins/antagonists & inhibitors/immunology
Identifiers
PMID: 26198921
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Research group Groupe Desmeules Jules (pharmacologie/toxicologie) (567)
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DERFUSS, Tobias et al. 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. In: Journal of Neuroimmunology, 2015, vol. 285, p. 68-70. https://archive-ouverte.unige.ch/unige:78723

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Deposited on : 2015-12-16

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