Can-Fite推进先进的肝癌治疗

StephenW

Can-Fite moves forward with advanced liver cancer therapy
May 6, 2019

The FDA granted both orphan drug designation and fast track status to Namodenoson, an advanced liver cancer therapy candidate from Can-Fite BioPharma, according to a press release.

Can-Fite recently announced results from a phase 2 study of Namodensson, in which the therapy increased overall survival in patients with hepatocellular carcinoma and Child-Pugh class B7 compared with placebo, although the trial did not meet its primary endpoint.

Despite not meeting the phase 2 primary endpoint, Can-Fite has a meeting with the FDA to review a plan for a phase 3 clinical trial.

“We look forward to our upcoming meeting with the FDA regarding our phase 3 study design,” Pnina Fishman, CEO of Can-Fite, said in the release. “We are hopeful that based on efficacy data in the largest subgroup of the patient population from our phase 2 study, we can move forward into a pivotal phase 3 trial for marketing approval with the guidance of the FDA.”

Namodenoson is a small orally bioavailable drug that binds to the A3 adenosine receptor. The therapy is also being evaluated as a treatment for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.

Reference: www.canfite.com

StephenW

Can-Fite推进先进的肝癌治疗
2019年5月6日

根据一份新闻稿，FDA向Can-Fite BioPharma的晚期肝癌治疗候选人Namodenoson颁发了孤儿药指定和快速通道状态。

Can-Fite最近公布了Namodensson的2期研究结果，其中该疗法与安慰剂相比，增加了肝细胞癌患者和Child-Pugh B7类患者的总生存期，尽管该试验未达到其主要终点。

尽管未达到第2阶段的主要终点，但Can-Fite已与FDA会面以审查第3阶段临床试验的计划。

“我们期待即将与FDA就我们的第3阶段研究设计进行会面，”Can-Fite首席执行官Pnina Fishman在发布会上表示。 “我们希望根据患者群体中最大亚组的疗效数据从我们的第2阶段研究中，我们可以在FDA的指导下进入关键的3期试验进行上市批准。”

Namodenoson是一种小的口服生物可利用药物，可与A3腺苷受体结合。该疗法还被评估为非酒精性脂肪肝和非酒精性脂肪性肝炎的治疗。

参考：www.canfite.com