Can-Fite: Namodenoson Gets Approval In Romania For Compassionate Use To Treat Advanced Liver Cancer

(RTTNews) - Can-Fite BioPharma Ltd. (CANF), an advanced clinical stage drug development company, announced Tuesday that its liver drug candidate Namodenoson has received approval in Romania for compassionate use for the treatment of patients with advanced liver cancer.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). It is being evaluated as a second line treatment for advanced hepatocellular carcinoma in a pivotal Phase III trial.

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 U.S., and five countries in Europe.

The trail received a 'green light' to proceed from the U.S. Food and Drug Administration or FDA and the European Medicines Agency or EMA. 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.

Can-Fite CEO Pnina Fishman said, "The anti-cancer effect of Namodenoson together with its liver protective properties make it unique among anti-cancer drugs for this devastating disease."

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

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