24 February 2023 - - Israeli biotechnology company Can-Fite BioPharma Ltd's (NYSE MKT: CANF) (TASE: CFBI) liver drug candidate Namodenoson has been approved for compassionate use for the treatment of patients with advanced liver cancer in Romania, the company said.

Namodenoson was previously approved for compassionate use in Israel, where advanced liver cancer patients have been treated for several years.

In parallel, Can-Fite's pivotal Phase III study in patients with advanced liver cancer (hepatocellular carcinoma), is open for patient enrolment and will recruit patients in Israel, the US, and five countries in Europe.

This pivotal study received a 'green light' to proceed from the US Food and Drug Administration and the European Medicines Agency, and if successfully concluded, the company will be in a position to submit the drug for approval with each of the regulatory authorities.

Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.

The hepatocellular carcinoma drug market is expected to reach USD 3.8bn in 2027 in the G8 countries according to DelveInsight.

The American Cancer Society estimates that in the US, liver cancer incidence has tripled since 1980, with an estimated 41,000 cases diagnosed and 31,000 deaths annually.

Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated as a second line treatment for advanced hepatocellular carcinoma in a pivotal Phase III trial.

The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis.

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.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development company with a platform technology that is designed to address markets in the treatment of cancer, liver, and inflammatory disease.

The company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis.

Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis, and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma, the most common form of liver cancer.

Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.

The company said CF602, its third drug candidate, has shown efficacy in the treatment of erectile dysfunction.