Namodenoson (CF102)

Drug Product

Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5'- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR).

Preclinical Pharmacology

Namodenoson has a potent anti-cancer effect, particularly against hepatocellular and pancreatic carcinoma, as well as anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation and MASH.

Mechanism of Action

Namodenoson's mechanism of action is mediated via de-regulation of the NF-κB and the Wnt signal transduction pathways, resulting in apoptosis of tumor cells. The protective effect of Namodenoson is mediated via the induction of positive cytokines, e.g., adiponectin and G-CSF which induce anti-inflammatory, anti-fibrosis, anti-steatosis effects in the liver.

Safety

The safety of Namodenoson has been demonstrated in preclinical studies, and in Phase I and Phase II clinical studies showing a very a favorable safety profile.

Efficacy

  1. Hepatocellular Carcinoma
    A Phase I/II study in hepatocellular carcinoma (HCC) successfully met its primary and secondary endpoints demonstrating initial indications for efficacy of Namodenoson. A global Phase II study treating patients with Namodenoson as a second-line therapy has been concluded. Although the overall survival primary endpoint failed, a robust clinical effect has been demonstrated in a sub-population of Child Pugh B7 (CPB7) patients, which constitutes 70% of the whole patient population globally. In an End-of-Phase II meeting with the FDA, the Company reached an agreement with the agency on a Phase III protocol in the CPB7 population. An agreement on the pivotal Phase III study has also been reached with the European Medicines Agency (EMA) and this pivotal Phase III study is currently ongoing. An interim analysis is planned and if successful, the company may receive a conditional approval from the agencies and will be able to start marketing the drug.
  2. MASH (Metabolic-assotiated steatohepatitis)
    A Phase II study in patients with NASLD/MASH successfully met its endpoints.  A robust anti-inflammatory effect manifested by significant decrease in the liver enzymes ALT and AST and significant improvement in the positive cytokine adiponectin was recorded. A reduced liver fat content (LFC) and a reduction in % of liver fat volume was found together with a decrease in FIB-4 and FAST, non-invasive tests used as markers to exclude advanced fibrosis. Can-Fite is currently enrolling patients for a Phase IIb study . The protocol includes liver biopsy as an inclusion criterion and 129 patients will be included. Upon successful conclusion, This study will set the stage for a pivotal Phase III trial.