Journal
JOURNAL OF NEUROIMMUNOLOGY
Volume 246, Issue 1-2, Pages 100-107Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jneuroim.2012.03.007
Keywords
S1PR1; Lymphopenia; CD8 T cell subsets; Bradycardia; Fingolimod; Autoimmune disease
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Funding
- Daiichi Sankyo, Inc.
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CS-0777 is a selective sphingosine 1-phosphate receptor-1 modulator under investigation for treatment of multiple sclerosis (MS). We conducted an open-label, pilot study in 25 MS patients to assess the safety, pharmacokinetics, pharmacodynamics and exploratory efficacy of oral CS-0777 (0.1, 0.3 and 0.6 mg), administered once weekly or every other week for 12 weeks. CS-0777 resulted in a pronounced, dose-dependent decrease in lymphocytes and CD4 T cell subsets, which returned to baseline within 4 weeks after the last dose. Overall, CS-0777 was safe and well-tolerated. These results require confirmation in a double-blind, placebo-controlled and adequately powered phase 2 study in MS. (C) 2012 Elsevier B.V. All rights reserved.
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