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.

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.

• Authors: Tobias Derfuss, François Curtin, Claudia Guebelin, Claire Bridel, Maria Rasenack, Alain Matthey, Renaud Du Pasquier, Myriam Schluep, Jules Desmeules, Alois B Lang, Hervé Perron, Raphael Faucard, Hervé Porchet, Hans-Peter Hartung, Ludwig Kappos, Patrice H Lalive
• Journal: Journal of neuroimmunology (J Neuroimmunol) Vol. 285 Pg. 68-70 (Aug 15 2015) ISSN: 1872-8421 [Electronic] Netherlands
• PMID: 26198921 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier B.V. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Viral Envelope Proteins
• temelimab

Topics

• Aged
• Antibodies, Monoclonal, Humanized (pharmacology, therapeutic use)
• Cohort Studies
• Endogenous Retroviruses (drug effects, immunology)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Multiple Sclerosis (drug therapy, immunology)
• Viral Envelope Proteins (antagonists & inhibitors, immunology)