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 carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation.

Mechanism of Action
Namodenoso`sn 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 down-regulation of the NF-kB signal transduction pathway and preventing apoptosis.

Safety
The safety of Namodenoson has been demonstrated in preclinical studies, and Phase I and Phase II clinical studies demonstrating 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 recently 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. 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.

2. NASH (Nonalcoholic steatohepatitis) 

A Phase II study in patients with NAFLD/NASH 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 now preparing a Phase IIb study in this indication.