Novel Approach To Treating Advanced Liver Cancer With Namodenoson Published In Leading Scientific Journal: 12-Month Survival Of 44% For Namodenoson Vs. 18% For Placebo
Novel Approach To Treating Advanced Liver Cancer With Namodenoson Published In Leading Scientific Journal: 12-Month Survival Of 44% For Namodenoson Vs. 18% For Placebo
Namodenoson has been granted both Orphan Drug and Fast Track designations by the FDA and has received Orphan Drug status with the EMA.- Namodenoson is being evaluated in a pivotal Phase III study
- Namodenoson is approved for compassionate use in the treatment of liver cancer in Israel and Romania
- 一项关键的III期研究正在对Namodenoson进行评估
- 在以色列和罗马尼亚，Namodenoson被批准用于治疗肝癌
Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that Purinergic Signalling, a peer-reviewed scientific journal focused on molecules which target adenosine receptors, published an article titled "Targeting the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects" authored by Can-Fite's CEO Dr. Pnina Fishman and others.
Can-Fite BioPharma Ltd.（纽约证券交易所代码：CANF）（TASE：CFBI）今天宣布，该公司正在开发一系列治疗炎症、癌症和肝脏疾病的专有小分子药物 嘌呤能信号是一本专注于靶向腺苷受体的分子的同行评审的科学期刊，发表了一篇由Can-Fite首席执行官Pnina Fishman博士等人撰写的题为 “靶向A3腺苷受体治疗肝细胞癌：抗癌和保肝作用” 的文章。
The article includes a review of the novel approach for treating advanced liver cancer with Namodenoson, a small molecule orally bioavailable drug which specifically kills cancer cells and leaves normal liver cells unharmed. Efficacy and safety data are presented from Phase I and II human clinical studies. Treatment with Namodenoson resulted in longer overall survival in patients with advanced liver cancer as defined by Child Pugh B (CPB) stage in a statistically significant manner. The drug has shown to have a very favorable safety profile and exert a protective effect on liver cancer cells.
本文综述了使用Namodenoson治疗晚期肝癌的新方法，Namodenoson是一种小分子口服生物可利用药物，可特异性杀死癌细胞并使正常肝细胞不受伤害。疗效和安全性数据来自I期和II期人体临床研究。使用Namodenoson治疗可延长Child Pugh B（CPB）阶段定义的晚期肝癌患者的总体存活率，具有统计学意义。该药物已被证明具有非常好的安全性，并对肝癌细胞具有保护作用。
Currently, Namodenoson is being evaluated in a pivotal Phase III study. The study protocol has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with 450 patients to be enrolled in Israel, Europe, and the U.S. An interim data analysis will be performed.
目前，纳莫德诺森正在一项关键的III期研究中接受评估。该研究方案已获得美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）的批准，将在以色列、欧洲和美国招收450名患者。将进行中期数据分析。
Namodenoson has been granted both Orphan Drug and Fast Track designations by the FDA and has received Orphan Drug status with the EMA.
Namodenoson已获得美国食品药品管理局的孤儿药和快速通道认证，并获得了EMA的孤儿药资格。
"With Namodenoson, we are aiming to treat patients with the greatest need—those with advanced liver cancer CPB. Moreover, this category of patients are typically not enrolled by other clinical studies due to the severity of their disease," Dr. Fishman stated. "We are hopeful that Namodenoson's novel approach may be effective in our current pivotal Phase III trial based on positive results in our prior Phase II study with this advanced liver cancer population. Additionally, we are highly encouraged by the case of a patient from the Phase II study who cleared all liver cancer and remains cancer-free for six years while treated with Namodenoson."
“通过Namodenoson，我们的目标是治疗需求最大的患者——晚期肝癌CPB患者。此外，由于疾病的严重程度，这类患者通常不被其他临床研究纳入名单，” 菲什曼博士说。“基于我们先前对这些晚期肝癌人群的II期研究的积极结果，我们希望Namodenoson的新方法可能在我们当前的关键III期试验中有效。此外，来自II期研究的一位患者的案例令我们深受鼓舞，该患者在接受Namodenoson治疗期间清除了所有肝癌，并在六年内保持无癌状态。”
