Policy & Regulation
Can-Fite Enrolls First Patient in Phase II COVID-19 Study Under FDA Protocol
5 March 2021 - - Israel-based biotechnology company Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) has enrolled the first of 40 patients in its Phase II COVID-19 study, the company said.

The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care vs. placebo plus SSC in patients hospitalized with moderate to severe COVID-19, as defined by the US 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 US patent US7589075. Piclidenoson also inhibits cytokine release syndrome which is associated with the severity of COVID-19.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

It is currently being evaluated in a multinational Phase III study as a treatment for moderate to severe psoriasis and a Phase II US study for the treatment of moderate to severe COVID-19.

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-bn dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19.

The company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19.

Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma, the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis.

Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US 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.