Abstract
A human recombinant T cell receptor ligand (RTL1000) consisting of DR2 α1 and β1 domains linked covalently to MOG-35-55 peptide can reverse clinical and histological signs of experimental autoimmune encephalomyelitis (EAE), and was evaluated for safety in a Phase 1 randomized, placebo-controlled, escalating dose study in 34 subjects with multiple sclerosis (MS). RTL1000 was safe and well tolerated at a dose of ≤60 mg that is well within the effective dose range for EAE and did not cause worsening of MS disease at doses ≤200 mg. RTL1000 represents a novel approach for the treatment of MS that promises potent immunoregulation and CNS repair without global immunosuppression.
Copyright © 2010 Elsevier B.V. All rights reserved.
Publication types
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Clinical Trial, Phase I
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, Non-P.H.S.
MeSH terms
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Animals
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Dose-Response Relationship, Immunologic
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Double-Blind Method
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Encephalomyelitis, Autoimmune, Experimental / drug therapy
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Encephalomyelitis, Autoimmune, Experimental / immunology
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Humans
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Mice
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Mice, Inbred C57BL
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Mice, Transgenic
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Multiple Sclerosis / drug therapy*
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Multiple Sclerosis / immunology
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Protein Structure, Secondary
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Rats
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Rats, Inbred Lew
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Recombinant Fusion Proteins / chemistry
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Recombinant Fusion Proteins / therapeutic use*
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Recombinant Proteins / chemistry
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Recombinant Proteins / therapeutic use
Substances
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RTL1000 protein
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Recombinant Fusion Proteins
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Recombinant Proteins