Due to Patient Survival Top line Results of the Namodenoson Phase II
Advanced Liver Cancer Trial Expected Q1/19
|●||Namodenoson seeks to address a major unmet need for Child Pugh B patients with advanced liver cancer|
|●||Namodenoson has received Fast Track Status in the U.S. and Orphan Drug Designation in Europe and the U.S.|
PETACH TIKVA, Israel, October 31, 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 provided an update on its Phase II clinical trial of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child Pugh B whose disease has progressed on sorafenib therapy. Due to patient survival, top line efficacy results are expected during the first quarter of 2019.
Enrollment of 78 patients was completed in August 2017 and the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo).
The statistical plan for this trial requires that the primary efficacy analysis occurs when no more than 3 of the original 78 patients survive. At the outset of the trial, it was assumed that patients with advanced HCC with Child-Pugh B had a relatively poor prognosis, and that within approximately a year of enrollment of the last subject, primary efficacy analysis could be conducted. In order to maintain the statistical integrity of the trial as well as adhere to the principles of Good Clinical Practice, the Company estimates that it will un-blind the data during Q1/19.
Can-Fite’s CEO, Dr. Pnina Fishman, commented, “This unexpectedly prolonged longevity is unquestionably beneficial for the individual patients, and gives us hope that Namodenoson may eventually prove its value in this patient population.”
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 Phase III trials for rheumatoid arthritis and psoriasis. 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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