On July 2, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that U.S. researchers published scientific findings recommending development of anti-Liver Cancer Drugs based on a mechanism of action utilized by Namodenoson (Press release, Can-Fite BioPharma, JUL 2, 2018, View Source [SID1234527537]).
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Can-Fite extensively published that its anti-cancer drug candidate, Namodenoson, inhibits a specific molecular signaling pathway in the liver cancer cells, designated as the Wnt/β-catenin, and is responsible for the development and progression of hepatocellular carcinoma (HCC). The scientific article published on June 28, 2018 by key opinion leaders from the University of Texas MD Anderson Cancer Center, Houston, TX, USA, recommends that targeting and inhibiting the very same Wnt/β-catenin pathway leads to an anti-cancer effect against hepatocellular carcinoma (Role of Wnt/β catenin signaling in hepatocellular carcinoma pathogenesis and clinical significance; Authors: Khalaf AM, Fuentes D, Morshid AI, Burke MR, Kaseb AO, Hassan M, Hazle JD, Elsayes KM. View Source)
"We are very excited to read the MD Anderson group article which we consider as important validation of Can-Fite’s scientific approach to the development of Namodenoson for the treatment of liver cancer. We’re proud to be working in the forefront of research of HCC with our orally available drug Namodenoson with its unique mechanism of action as an anti-cancer agent and its favorable safety profile. We look forward to data release from our ongoing Phase II advanced liver cancer trial," stated Can-Fite CEO Dr. Pnina Fishman.
The currently ongoing global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.
Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.
Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.