On March 3, 2020 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, reported 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 (Press release, Can-Fite BioPharma, MAR 3, 2020, View Source [SID1234555097]). 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 1500 patients.
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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 inlater this month.