Can-Fite Seeks FDA Orphan Drug Status for Namodenoson in Pancreatic Cancer

PETACH TIKVA, Israel, July 11, 2024 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology firm focused on developing small molecule drugs for cancer and inflammatory conditions, has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its drug Namodenoson for treating pancreatic carcinoma.

The U.S. Orphan Drug Act of 1984 defines an orphan drug as one intended to treat conditions affecting fewer than 200,000 people in the U.S. Obtaining orphan designation provides several benefits, including seven years of market exclusivity upon approval, a tax credit covering 50% of clinical trial expenses, exemption from Prescription Drug User Fee Act (PDUFA) application fees, assistance in drug development, and eligibility for Orphan Products Grant funding.

Can-Fite intends to launch a Phase IIa clinical trial soon. This will be a multicenter, open-label study involving patients with advanced pancreatic adenocarcinoma who have not responded to at least one prior therapy. The study aims to assess the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson. All participants will receive 25 mg of oral Namodenoson twice daily over 28-day cycles, with regular safety evaluations. Around 20 patients will be recruited for this trial. The primary goal is to determine the safety profile of Namodenoson, while the secondary goal is to evaluate its clinical activity using various metrics such as Objective Response Rate (ORR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS) based on RECIST 1.1 criteria.

Namodenoson has already received Orphan Drug Status from both the FDA and the European Medicines Agency (EMA) for treating advanced liver cancer.

Motti Farbstein, CEO of Can-Fite, emphasized the significance of the Orphan Drug application for Namodenoson, highlighting the urgent need for safe and effective treatments for pancreatic carcinoma. Farbstein expressed confidence that Namodenoson could offer both efficacy and safety, which has been demonstrated in other clinical contexts. Market exclusivity upon approval would be a substantial advantage for Can-Fite.

Namodenoson is an orally available small molecule that selectively binds to the A3 adenosine receptor (A3AR). It has been tested in Phase II trials for hepatocellular carcinoma and for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells and minimally in normal cells, contributing to Namodenoson’s excellent safety profile.

Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company targeting cancer, liver, and inflammatory diseases. Its platform aims to penetrate multi-billion dollar markets. The company's lead drug candidate, Piclidenoson, has recently reported positive results in a Phase III trial for psoriasis. Namodenoson is also under evaluation in a Phase IIb trial for NASH and a Phase III trial for hepatocellular carcinoma (HCC), with plans for a Phase IIa study in pancreatic cancer. Besides its orphan drug status in the U.S. and Europe, Namodenoson has Fast Track Designation for HCC by the FDA. It has shown potential in treating other cancers, such as colon, prostate, and melanoma. Can-Fite’s third drug candidate, CF602, has demonstrated efficacy in treating erectile dysfunction. These drugs have shown excellent safety profiles with extensive clinical experience in over 1,600 patients.

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