RTL therapy for multiple sclerosis: a Phase I clinical study.
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.
Offner
Halina
H
Neuroimmunology Research, Veterans Affairs Medical Center, 3710 SW US Veterans' Hospital Rd., Portland, OR 97239, United States. offnerva@ohsu.edu
Sinha
Sushmita
S
Burrows
Gregory G
GG
Ferro
Adolph J
AJ
Vandenbark
Arthur A
AA
D000818:Animals; D004306:Dose-Response Relationship, Immunologic; D004311:Double-Blind Method; D004681:Encephalomyelitis, Autoimmune, Experimental / Q000188:drug therapy / Q000276:immunology; D006801:Humans; D051379:Mice; D008810:Mice, Inbred C57BL; D008822:Mice, Transgenic; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000276:immunology; D017433:Protein Structure, Secondary; D051381:Rats; D011917:Rats, Inbred Lew; D011993:Recombinant Fusion Proteins / Q000737:chemistry / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000737:chemistry / Q000627:therapeutic use
C542328:RTL1000 protein; D011993:Recombinant Fusion Proteins; D011994:Recombinant Proteins