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首页> 外文期刊>Journal of Neuroimmunology: Official Bulletin of the Research Committee on Neuroimmunology of the World Federation of Neurology >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
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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

机译：IIa期随机临床研究测试GNbAC1，这是一种针对多发性硬化症患者的多发性硬化症相关内源性逆转录病毒包膜蛋白的人源化单克隆抗体-十二个月的随访

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摘要

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 12 months of a trial testing GNbAC1 in 10 MS patients at 2 and 6 mg/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. (C) 2015 Elsevier B.V. All rights reserved.
机译：GNbAC1是一种针对MSRV-Env的人源化单克隆抗体，MSRV-Env是一种内源性逆转录病毒蛋白，在多发性硬化症（MS）病变中表达，具有促炎作用并抑制少突胶质前体细胞分化。本文介绍了以10 mg / kg和2 mg / kg剂量对10名MS患者进行GNbAC1试验的开放标签扩展期，最长可达12个月。主要目标是评估GNbAC1安全性，其他目标是药代动力学和药效动力学评估。在扩展研究中，其余8名患者未发生安全性问题。未检测到抗GNbAC1抗体。 GNbAC1的耐受性良好。 （C）2015 Elsevier B.V.保留所有权利。

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