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 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
- 納米丹諾森正在一項關鍵的第三期研究中進行評估
- Namodenoson 被批准用於以色列和羅馬尼亞的肝癌治療富有同情心
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.
坎菲特生物製藥有限公司（紐約證券交易所代碼：CANF）（TASE：CFBI）是一家生物技術公司，致力於推進一系列專有的小分子藥物，以解決炎症，癌症和肝臟疾病的專有小分子藥物。 嘌呤能信號, 一份同行評審的科學雜誌，專注於靶向腺苷受體的分子, 發表了一篇題為「針對 A3 腺苷受體治療肝細胞癌:抗癌和保肝作用」的文章由 CAN-Fite 的首席執行官 Pnina Fishman 博士和其他人撰寫.
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.
本文包括對治療晚期肝癌的新方法的回顧 Namodenoson，Namodenoson 是一種小分子口服生物利用藥物，專門殺死癌細胞並使正常肝細胞不受傷害。有效性和安全性數據從 I 期和 II 期人體臨床研究中提供。Namodenoson 治療導致兒童 Pugh B（CPB）階段定義的晚期肝癌患者的整體生存期更長，具有統計學意義。該藥物已證明具有非常有利的安全性，並對肝癌細胞產生保護作用。
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，納米丹諾森正在一項關鍵的第三階段研究中進行評估。該研究協議已獲得美國食品和藥物管理局（FDA）和歐洲藥品管理局（EMA）的批准，其中 450 名患者將在以色列，歐洲和美國註冊，將進行臨時數據分析。
Namodenoson has been granted both Orphan Drug and Fast Track designations by the FDA and has received Orphan Drug status with the EMA.
Namodenoson 已被 FDA 授予孤兒藥物和快速通道名稱，並已獲得 EMA 的孤兒藥物狀態。
"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."
「與 Namodenoson 一起，我們的目標是治療最需要的患者-晚期肝癌 CPB 的患者。此外，由於疾病的嚴重程度，這類患者通常不會被其他臨床研究招收。」菲什曼博士說。「我們希望 Namodenoson 的新穎方法可能在我們目前關鍵的 III 期試驗中有效，這是基於我們先前對該晚期肝癌人群的 II 期研究的積極結果。此外，我們對第二期研究中的一名患者的高度鼓舞，該病人清除了所有肝癌，並在使用 Namodenoson 治療期間仍然無癌六年。」