On 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, reported 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 (Press release, Can-Fite BioPharma, OCT 31, 2018, View Source [SID1234530414]). Due to patient survival, top line efficacy results are expected during the first quarter of 2019.
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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.
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.