Can-Fite Enters Into Collaboration Agreement to Explore Namodenoson’s Anti-NASH Effect With Icahn School of Medicine at Mount Sinai in NYC

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, announced a collaborative research agreement with the Icahn School of Medicine at Mount Sinai in New York City. The agreement will support research directed by Scott Friedman, M.D., Dean for Therapeutic Discovery and Chief of the Division of Liver Diseases at the Icahn School of Medicine. The research is aimed at transcriptomic and molecular analyses to further explore the mechanisms of action of Namodenoson (CF102) in human hepatic stellate cells in order to clarify its effect on fibrogenesis that occurs in non-alcoholic steatohepatitis (NASH).

"We are privileged to work with Dr. Friedman, a Key Opinion Leader in the arena of nonalcoholic fatty liver disease (NAFLD) and NASH, to further study and advance our understanding of the molecular mechanism of action of Namodenoson," said Pnina Fishman, Ph.D., Founder and Chief Executive Officer of Can-Fite. “This work aims to provide a more solid foundation for our ongoing efforts to understand the potential of Namodenoson in these therapeutic areas.”

In the transcriptomic bioinformatics analysis, Dr. Friedman will research differentially expressed genes and modulated molecular pathways in the transcriptome datasets in association with the experimental perturbations. Integrative (cross-species) analysis with clinical datasets for assessment of association with clinical disease phenotypes and outcomes will be performed. An emphasis will be given to the analysis of the PI3K and the Wnt/β-catenin pathways, which are up-regulated in NAFLD/NASH livers and found to be improved upon treatment with Namodenoson.

Recent preclinical studies with Namodenoson in collaboration with Rifaat Safadi, M.D., the Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center in Israel, showed an improvement in three cardinal NASH parameters including steatosis, inflammation and fibrosis.

Can-Fite is currently enrolling patients in a Phase II study of Namodenoson in NAFLD/NASH. Based on the recent preclinical data, the primary endpoint of the Phase II study is Percent Change From Baseline (PCFB) in serum alanine aminotransferase (ALT) levels at Week 12 for each dose of CF102 compared to placebo, with the major secondary endpoint being percentage of liver fat as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).