以治愈艾滋病为目标!FDA批准美国基因技术公司(AGT)推进HIV治愈计划的I期临床

2020-08-12 Allan MedSci原创

AGT103-T是一种基于慢病毒载体的基因疗法,旨在彻底清除HIV,该疗法可以修复HIV对免疫系统造成的损害,并允许自然免疫反应来控制病毒。

艾滋病已经影响社会超过四十年。在全球范围内,将近3800万人感染了艾滋病病毒,在美国,有超过100万人感染了艾滋病病毒。迄今为止,治愈该疾病的努力一直没有成功。

美国基因技术公司(AGT)今日宣布,已获得FDA的批准,将开始进行I期临床试验,以验证基因疗法AGT103-T治疗艾滋病的有效性和安全性,这也是AGT103-T的首次人体试验。AGT将在华盛顿健康研究所、马里兰大学、人类病毒研究所和乔治敦大学的临床中心进行其I期研究。这些中心预计将于2020年9月开始注册,AGT希望在年底之前报告初始数据。AGT的I期临床试验将研究AGT103-T的安全性、测量关键的生物标志物并探索功效的替代标志物。 

AGT103-T是一种基于慢病毒载体的基因疗法,旨在彻底清除HIV,该疗法可以修复HIV对免疫系统造成的损害,并允许自然免疫反应来控制病毒。根据其研究,AGT认为AGT103-T可以治愈艾滋病。AGT103-T细胞产品是由血细胞经11天的过程制成的,该过程可增加对抗HIV的T细胞并使用基因疗法帮助这些细胞在体内存活。临床前研究表明,AGT103-T能够清除HIV。

AGT对AGT103-T的表征是与美国国立卫生研究院(National Institutes of Health)的国家过敏和传染病研究所(NIAID)合作完成的。由AGT和NIAID科学家共同撰写的同行评议文章于2020年6月发表在《分子疗法》上,该文章描述了AGT103-T制造工艺的演变过程。

 

原始出处:

https://www.firstwordpharma.com/node/1748453?tsid=4

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    2020-10-15 bugit
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    2020-08-13 Jessica

    希望临床实验成功#艾滋病#

    0

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    2020-08-12 176AebO2054

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