On September 23, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the Company’s Medical Director, Dr. Michael Silverman, has delivered a presentation titled "The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study" at the International Liver Cancer Association (ILCA) annual conference on September 22, 2019 during the Novel Targets and Prognostic Markers Session (Press release, Can-Fite BioPharma, SEP 23, 2019, View Source [SID1234539689]). The ILCA’s 13th Annual Conference took place from September 20 to 22, 2019 in Chicago, Illinois. While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78), superiority in overall survival was found in the largest study subpopulation of patients who were classified Child Pugh B7 (CPB7, n=56) based on severity of the underlying cirrhosis, as compared to the placebo treated group. The Phase III study protocol which has already been designed by the Company will include CPB7 patients and will be presented to the U.S. FDA in a scheduled End of Phase II Meeting.
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Highlights from Dr. Silverman’s presentation included:
●Median overall survival in the CPB7 population of 6.8 months for those treated with Namodenoson as compared to 4.3 months for those treated with placebo
●A partial response rate of 9% in the Namodenoson group versus 0% in the placebo group
●1-year survival in the CPB7 population was 44% for the Namodenoson treated group, as compared to 18% for patients dosed with placebo (p=0.028)
●Subgroup analyses using a variety of demographic and baseline disease characteristics, such as sex, performance status, and HCC disease status indicate the overall survival advantage of Namodenoson over placebo persists in the vast majority of the subgroups
●The safety profile of Namodenoson continues to be highly favorable, and adverse events related to Namodenoson were generally mild or moderate and transitory, and did not require dose reduction or drug withdrawal
"These results attest to the robustness of Namodenoson activity in treating liver cancer. We have designed the Phase III trial to focus on the CPB7 subpopulation, and we look forward to meeting with the FDA soon to present the protocol and move forward with patient recruitment," stated Dr. Silverman.
The ILCA is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines. Its mission is to lead a global community of physicians, scientists and allied professionals through education and research with the goal to better prevent and treat liver cancer.
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 as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial 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.