• Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the current pivotal Phase 3 clinical study

RAMAT GAN, Israel / May 13, 2024 / Business Wire / 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, today announces that it held a conference for 75 oncologists and coordinators who are conducting the pivotal Phase 3 advanced liver cancer study, to accelerate patient enrolment.

The participants have been presented with the drug chemical and biological profile and the study protocol as well as study procedures. Dr. Lencioni, a key opinion leader in radiology of liver tumors, Department of Radiology, Pisa University School of Medicine Italy, educated the oncologists on the way to measure tumor lesion size prior and post namodenoson treatment. The difference in tumor growth or regression defines progression free survival (PFS) and the objective response rate (ORR) to the drug, serving as part of the study objectives. US experts presented to the participants the electronic data entry of the patients’ data during the trial.

"The conference was very successful and we are very pleased with the enthusiasm of the participants with respect to the drug characteristics. They are looking forward to complete patient enrolment and conclude the data of this very promising anti-cancer drug," said Dr. Pnina Fishman, Can-Fite CSO and Executive Chairperson.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase 3 clinical study which is now enrolling patients is Israel, Europe and the US. The study is designed to perform an interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective.

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.

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 and is expected to commence a pivotal Phase III. Can-Fite’s cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal 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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