Full Press Release Details
Completes Phase II COVID-19 Protocol Based on FDA Guidance, Plans to File IND Shortly
to be evaluated for the treatment of COVID-19 infected patients with moderate symptoms
TIKVA, Israel, July 15, 2020 -- 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, announced today that it has
amended its Phase II COVID-19 study protocol based on inputs from the U.S. Food and Drug Administration (FDA) and its Pre-Investigational
New Drug (IND) fling. The Company plans to file an IND application with its completed protocol before the end of July.
Phase II study titled, "Piclidenoson for Treatment of COVID-19 - A Randomized, Double Blind, Placebo-Controlled Trial"
is a pilot trial in a population of hospitalized patients who all receive standard supportive care. Eligible patients are those
diagnosed with "moderate" COVID-19 per U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment
Guidelines. Forty patients will be randomly assigned in a 1:1 ratio to the trial arms of Piclidenoson 2 mg 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.
believe Piclidenoson is a promising candidate to treat COVID-19 because it combines both anti-viral and anti-rheumatic properties
in one drug. Recent studies have shown anti-viral and anti-rheumatic drugs have improved outcomes for COVID-19 patients, leading
to the U.S. FDA issuing emergency use authorization for the anti-viral drug remdesivir for the treatment of COVID-19, while some
U.S. hospitals are treating COVID-19 patients with Actemra (tocilizumab), a rheumatoid arthritis drug," stated Can-Fite
CEO Dr. Pnina Fishman.
an A3 adenosine receptor (A3AR) agonist, has a well-established safety record in the U.S. and globally, and has been dosed in
over 1,000 patients in clinical studies for the treatment of rheumatoid arthritis and psoriasis. The use of A3AR agonists as potent
anti-inflammatory agents in addition to standard of care in acute infectious diseases where host defense responses are overwhelming,
leading to cytokine storm and death, is supported by several peer reviewed studies, as well as by Can-Fite's own work in
the field of adenosine biology. A3AR agonists are effective in models of inflammation and sepsis.
is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic
index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory
diseases and for the treatment of COVID-19. It is being evaluated in multinational Phase III studies as a first line treatment
to replace methotrexate in the treatment of rheumatoid arthritis, and as a treatment for moderate-to-severe psoriasis.
Can-Fite BioPharma Ltd.
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 COVID-19. The Company's
lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver drug,
Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), 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 (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.
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