FDA接受新药申请肝癌T细胞治疗

StephenW

FDA accepts new drug application for liver cancer T-cell therapy
January 30, 2019

Eureka Therapeutics announced that the FDA has cleared its investigational new drug application for ET140202 ARTEMIS T-cell therapy for patients with hepatocellular carcinoma who are positive for alpha-fetoprotein, according to a press release.

“This is an exciting time for Eureka as we prepare to initiate our U.S. clinical trial in patients with hepatocellular carcinoma,” Cheng Liu, PhD, president and CEO of Eureka Therapeutics, said in the release. “HCC is an area of significant unmet medical need and patient options are currently limited. We intend to advance ET140202 as rapidly as possible in the U.S. and to build upon the experience from our promising proof-of-concept study in China.”


Eureka plans to initiate a phase 1/2 multicenter clinical trial in the U.S. during the first half of 2019. Investigators will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ET140202 through dose escalation in phase 1 followed by dose expansion in phase 2.

Previously reported results from a first-in-human study in China showed that ET140202 demonstrated a favorable safety profile in six patients with no observed cytokine release syndrome or drug-related neurotoxicity. Additionally, three of the six patients achieved tumor regression.

Reference: www.eurekatherapeutics.com

StephenW

FDA接受新药申请肝癌T细胞治疗
2019年1月30日

根据一份新闻稿，Eureka Therapeutics宣布FDA已经批准了针对甲胎蛋白阳性的肝细胞癌患者的ET140202 ARTEMIS T细胞治疗的新药申请。

Eureka Therapeutics公司总裁兼首席执行官Cheng Liu博士在发布会上表示，“对于Eureka来说，这是一个激动人心的时刻，因为我们准备启动我们在肝细胞癌患者的美国临床试验。” “HCC是一个未满足医疗需求的领域，目前患者选择有限。我们打算在美国尽快推进ET140202，并借鉴我们在中国有前途的概念验证研究的经验。“


Eureka计划于2019年上半年在美国启动1/2阶段多中心临床试验。研究人员将通过第1阶段的剂量递增评估ET140202的安全性，耐受性，药代动力学和初步抗肿瘤活性，随后进行剂量扩增。阶段2。

先前报道的中国首次人体研究结果显示，ET140202在6名未观察到细胞因子释放综合征或药物相关神经毒性的患者中表现出良好的安全性。此外，六名患者中有三名达到肿瘤消退。

参考：www.eurekatherapeutics.com