RTL therapy for multiple sclerosis: a Phase I clinical study.

RTL therapy for multiple sclerosis: a Phase I clinical study.
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DOI:
10.1016/j.jneuroim.2010.09.013
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发表时间:
2011-02
影响因子:
3.3
通讯作者:
Vandenbark, Arthur A.
Vandenbark, Arthur A.
中科院分区:
医学4区
文献类型:
--
作者:
Offner, Halina;Sinha, Sushmita;Burrows, Gregory G.;Ferro, Adolph J.;Vandenbark, Arthur A.

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由DR 2 α1和β1结构域与MOG-35-55肽共价连接组成的人重组T细胞受体配体(RTL 1000)可逆转实验性自身免疫性脑脊髓炎(EAE)的临床和组织学体征,并在34例多发性硬化症(MS)受试者中进行的I期随机、安慰剂对照、剂量递增研究中评价了其安全性。RTL 1000在剂量≤ 60 mg时安全且耐受性良好,该剂量完全在EAE的有效剂量范围内,并且在剂量≤ 200 mg时不会导致MS疾病恶化。RTL 1000代表了一种治疗MS的新方法,该方法有望实现有效的免疫调节和CNS修复,而无需全面的免疫抑制。
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 ≤60mg that is well within the effective dose range for EAE and did not cause worsening of MS disease at doses ≤200mg. RTL1000 represents a novel approach for the treatment of MS that promises potent immunoregulation and CNS repair without global immunosuppression.
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