with Mechanism of Action Utilized by Namodenoson are recommended by Leading
U.S. Researchers to be Developed to Combat Liver Cancer
|●||A third party validation for the Can-Fite scientific approach to combat Liver Cancer (https://www.dovepress.com/article_39060.t87482447)|
|●||A Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) is currently ongoing with Namodenoson and completed patients’ enrolment|
|●||Namodenoson has an Orphan Drug Designation in Europe and the U.S., as well as Fast Track Status in the U.S.|
PETACH TIKVA, Israel, 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, today announced that U.S. researchers published scientific findings recommending development of anti-Liver Cancer Drugs based on a mechanism of action utilized by Namodenoson.
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 hepato-cellular 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. https://www.dovepress.com/article_39060.t87482447)
“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.
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.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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