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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 >Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response.
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Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response.

机译：患有继发进行性多发性硬化症的患者的I期研究结果证明了氨基酸共聚物PI-2301的安全性，并可能诱导了抗炎性细胞因子反应。

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摘要

PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS. Treatment was given subcutaneously once weekly for 8 weeks, followed by a 4-week open-label treatment period with active drug. The most common adverse event was transient injection site reactions. Non-significant trend for increases in serum levels of IL-3, IL-13, and CCL22 over time were suggestive of a beneficial T(H)2 immune response in subjects dosed with PI-2301 at 3 and 10 mg. MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301.
机译：PI-2301是一种免疫调节剂，可以作为MS的替代疗法。在继发进行性MS患者中进行了安慰剂对照，多次上升剂量，双盲研究。每周一次皮下治疗，持续8周，然后进行4周开放标签治疗期的活性药物治疗。最常见的不良事件是短暂的注射部位反应。 IL-3，IL-13和CCL22的血清水平随时间增加的非显着趋势表明，以3和10 mg的PI-2301给药的受试者具有有益的T（H）2免疫应答。 MRI数据表明，用1毫克和3毫克PI-2301治疗的受试者的病变数目减少趋势不明显。

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