肝癌用药cf102，值得期待！

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FDA授予肝癌治疗药物CF102快速审定资格
来源：医脉通时间：2015-09-28

　　根据一份新闻稿显示，FDA已授予Can-Fite生物制药公司的CF102快速审定资格，这是治疗肝细胞癌的一种潜在药物。

　　据Can-Fite公司介绍，CF102是一种口服分子生物利用药物，作为A3腺苷受体激动剂，在多阶段1期和2期临床试验中具有抗肿瘤作用，可导致肝癌细胞死亡。

　　在美国、欧洲和以色列，一项2期随机安慰剂对照研究中，正在研究CF102用于原发性肝癌治疗的情况。这项研究预计将在2016上半年末完成研究对象的纳入，包括78例经Nexavar（索拉非尼，拜耳）治疗失败的Child-Pugh B级肝硬化患者。纳入患者接受25 mg CF102一日两次治疗。据Can-Fite公司介绍，这个剂量在先前的1期和2期临床试验中已经证明是安全有效的。

　　“我们非常庆幸，FDA认识到CF102用来治疗对Nexavar无应答的经治肝癌患者的潜力，” Can-Fite公司的首席执行官Pnina Fishman博士在新闻稿中说道。“我们认为快速审定资格是我们CF102发展过程中一个重要的催化剂，我们相信它能缩短CF102上市的时间，从而对患者产生相当大的影响。”

　　2014年，Can-Fite公司获得了CF102的FDA孤儿药审定资格，以及来自欧盟的专利。

英文原文

FDA grants fast track designation to CF102 for HCC

The FDA has granted fast track designation to Can-Fite BioPharma Ltd.’s CF102, a potential drug to treat hepatocellular carcinoma, according to a press release.

CF102, an oral molecular bioavailable drug, acts as an agonist at the A3 adenosine receptor and has demonstrated antitumor effects in multiple phase 1 and 2 clinical trials, resulting in liver cancer cell death, according to Can-Fite.

CF102 is currently being investigated for the treatment of HCC in a phase 2 randomized, placebo-controlled study in the U.S., Europe and Israel. The study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh B cirrhosis who failed treatment with Nexavar (sorafenib, Bayer). The enrolled patients are treated with 25 mg of CF102 twice per day. This dosage has been found to be safe and efficacious in previous phase 1 and 2 clinical trials, according to Can-Fite.

“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar,” Pnina Fishman, PhD, CEO of Can-Fite, said in the release. “We consider fast track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”

Can-Fite received orphan drug designation from the FDA for CF102 and a patent from the European Union in 2014.