Can-Fite BioPharma (CANF) Expands its Phase II COVID-19 Study to Europe

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced the expansion of its Phase II COVID-19 study of Piclidenoson to two European countries, Romania and Bulgaria.

The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment of Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson twice daily or placebo, and treated for up to 28 days. Efficacy will be assessed through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen. Safety and pharmacokinetic data will also be captured.

Piclidenoson’s robust anti-inflammatory effect has the potential to treat COVID-19 and its mutations because it treats disease manifestations. The drug has anti-inflammatory effects proven in Phase II psoriasis clinical studies and in an interim analysis of an ongoing Phase III psoriasis study. The drug’s anti-viral properties are protected by U.S. patent US7589075. Piclidenoson also inhibits cytokine release syndrome which is associated with the severity of COVID-19.

“We are making efforts to continue and test the effect of Piclidenoson on patients with COVID-19 since we believe that the robust anti-inflammatory effect of the drug together with its excellent safety profile may improve outcomes and we look forward to seeing its impact following 28 days of treatment. With the reduction in COVID-19 cases in Israel, we believe expansion into Europe will help speed up recruitment ” stated Can-Fite CEO Dr. Pnina Fishman.

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