RAMAT GAN, Israel, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient currently treated with Namodenoson in a compassionate use program in Can-Fite’s  Phase II Liver Cancer Study has an overall survival time of 8 years with a complete response.

The patient, who suffered from advanced liver cancer was enrolled in the former Can-Fite Phase II study,  continue to be treated with Namodenoson, and has now an overall survival of 8 years, with  disappearance of ascites, normal liver function, good quality of life and is defined as a long term complete response.

Can-Fite is currently enrolling patients in Israel, Europe and the US for a pivotal Phase III clinical study for patients with advanced HCC as a 2nd or 3rd line treatment and Namodenoson is administered twice daily orally.  The study protocol has been agreed upon with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

“With a very favorable safety profile and anti-cancer effect of Namodenoson, we are now enrolling patients for the pivotal Phase III clinical study where we expect to prolong patients’ overall survival, and see a response similar to that of the patient who has now been treated with Namodenoson for 8 years. The uniqueness of Namodenoson which specifically acts against the tumor cells and protects the normal liver cells, is the rationale for the conductance of the current trial,” stated Prof.  Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar 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 MASH a Phase III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: https://www.canfite.com/.

Forward-Looking Statements

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Contact

Can-Fite BioPharma
Motti Farbstein
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