PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biopharmaceutical company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it is submitting its annual Drug Safety Update Reports (DSUR) for both Piclidenoson and Namodenoson to the governing health regulatory agencies where its drug candidates are currently treating patients. Submission of the DSUR is an annual requirement for investigational-stage new drugs under development in territories which subscribe to the International Council for Harmonization guidelines, including the U.S. Food and Drug Administration and the European Medicines Agency. The DSUR includes updates on drug safety information such as adverse events, suspected unexpected serious adverse reactions, and other indicators of potential risk. Can-Fite’s reports being filed this year extend the growing body of documentation showing both Piclidenoson and Namodenoson have favorable safety profiles and risk-benefit ratios in more than 1,500 patients.

Dr. Michael Silverman, M.D., Can-Fite’s Medical Director, commented, “We welcome the opportunity to compile our cumulative data on a regular basis, as afforded by the DSUR process. As in years past, these snapshots of our safety data continue to confirm that both of our A3AR drugs in development are well-tolerated. We are pleased that there are no emerging safety concerns that could put patients at risk or impede our efforts to develop new drugs to meet unmet patient needs. These latest data are particularly robust, as we have achieved over 50% enrollment in both of our Phase III studies for Piclidenoson, as well as having completed two Phase II trials for Namodenoson.”

Piclidenoson is currently in two Phase III studies, one for the treatment of moderate-to-severe psoriasis to establish superiority versus placebo and non-inferiority versus Otezla® with over 50% of the planned 407 patients already enrolled; and another for the treatment of moderate-to-severe rheumatoid arthritis in newly diagnosed patients to establish non-inferiority to MTX, the standard of care, with over 50% of the planned 500 patients enrolled, and an interim analysis is planned. Namodenoson has completed a 78-patient Phase II study in liver cancer, and Can-Fite is currently preparing for a Phase III trial in this indication. Namodenoson has also recently completed enrollment in a 60 patient Phase II study in the treatment of NASH, with topline results expected later this month.

About Can-Fite BioPharma Ltd.

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 multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite’s liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.