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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该研究探讨了在患者友好的样本(尿液和宫颈阴道自收集样本)中检测卵巢癌的分子标志物,包括甲基化标志物、体细胞拷贝数变异和 DNA 片段化模式。

JCO | 芦可替尼与一线新辅助化疗联合治疗晚期卵巢癌的I期和II期随机对照研究

该研究旨在探讨芦可替尼与化疗联合用于初治晚期卵巢癌的耐受性和疗效,芦可替尼 15mg口服每日两次与紫杉醇和卡铂化疗联合应用在卵巢癌初治患者中表现出可接受的毒性,同时也达到Ⅱ期研究的主要终点。

Mol Cancer:复旦大学陈小军/吴小华等合作发现卵巢癌对PARP抑制剂获得性耐药的新机理

该研究证明,PARP1-DOT1L转录轴驱动卵巢癌对PARP抑制剂获得性耐药。