CF102 (Namodenoson) is a small molecule compound. Its mechanism of action is mediated via de-regulation of the NF-κB and the Wnt signal transduction, resulting in apoptosis of tumor cells; and conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which confers three downstream signal transduction pathways, the Wnt, NF-κB and α-SMA, altogether, controlling liver inflammation, fibrosis and steatosis. 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 product. CF102 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. FDA.
In April 2020, the Group’s partner Can-Fite BioPharma announced that CF102 achieved positive top-line results in the phase II study for NAFLD/NASH: meeting the efficacy endpoints and continuing to demonstrate good safety.
Primary liver cancer is currently the fourth most common malignant tumor in China and the third leading cause of death by cancer, among which, HCC accounts for 85% to more than 90%. NAFLD is the most common chronic liver disease worldwide, and the spectrum of NAFLD diseases includes non-alcoholic hepatic steatosis, NASH, etc. The prevalence of NAFLD in ordinary adults ranges from 6.3% to 45%, with 10% to 30% of cases being NASH. The prevalence of NAFLD in most Asian countries including China is at the middle-to-upper level (>25%), which has overtaken developed countries in Europe and the U.S. and become a new challenge in the field of liver disease and metabolism in China. Once proven in rigorous clinical trials, CF102 will provide a new treatment option for patients.
