基因疗法抗击卵巢癌:欧洲药品管理局授予GEN-1孤儿药认定

2020-03-24 Allan MedSci原创

肿瘤药物开发公司Celsion今日宣布,欧洲药物管理局(EMA)的孤儿药物产品委员会(COMP)已建议授予GEN-1孤儿药物资格,以治疗卵巢癌。

肿瘤药物开发公司Celsion今日宣布,欧洲药物管理局(EMA)的孤儿药物产品委员会(COMP)已建议授予GEN-1孤儿药物资格,以治疗卵巢癌。GEN-1是使用Celsion专有的TheraPlas平台技术设计的,是一种白介素12(IL-12)DNA载体,载体包裹在非病毒纳米颗粒递送系统中,该载体能够进行细胞转染,然后持续局部分泌IL-12蛋白。GEN-1先前曾获得美国食品药品监督管理局(FDA)的孤儿称号,目前正在I/II期临床试验(OVATION 2研究)中进行评估,以治疗初治III期和IV期卵巢癌患者。

卵巢癌是发源自女性卵巢的癌症,会产生会入侵以及转移到其他部位的异常细胞。卵巢癌初期症状不明显,随病情进展,才会出现许多癌症的典型症状,包括胀气、腹胀、骨盆痛等。癌症较容易扩散到腹膜、淋巴结、肺脏、肝脏等部位 。

 

原始出处:

https://www.firstwordpharma.com/node/1710199?tsid=4

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