The global presence of COVID-19 has caused so much tension and pressure to businesses and particularly the pharmaceutical industry. There is a rush against time in trying to develop a vaccine, which can combat the spread of coronavirus. Today, Can Fite Biopharma (NYSEAMERICAN:CANF) did confirm that it had revised its Phase II COVID-19 study protocol to incorporate additional inputs as advised by the FDA and its Pre-Investigational New Drug (IND) filing.
Phase II study will enroll 40 patients; the participants will be required to have been diagnosed with “moderate” COVID-19. This should be under the guidelines of the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.
The Phase II study titled, “Piclidenoson for Treatment of COVID-19 – A’’ is a trial pilot
The trial arms of Piclidenoson of 2mg will be administered twice daily or placebo. This will happen for 28 days, and on the 29th day, there will be an assessment of its efficacy through standard measures of clinical status. This will include evaluating the percentage of patients alive and free of respiratory failure and the percentage of those discharged without the requirement of additional oxygen.
Piclidenoson, an A3 adenosine receptor agonist (A3AR) and an orally bioavailable drug are under development as a potential treatment for autoimmune inflammatory diseases. Likely, it could also treat COVID-19, according to Dr. Pnina Fishman, Can-Fite CEO.
‘’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’’, Fishman commented.
Can-Fite’s Technology Addresses Multi-Billion Dollar Markets
The company has a wide portfolio of registered small molecule drugs. A majority of them address liver, inflammatory, and cancer diseases. Its platform technology is exceptional because it is designed for the needs of a multi-billion dollar market in cancer treatment.
Can-Fite already has a liver drug, Namodenoson, which has been granted Orphan Drug Designation in the U.S. and Europe. It is in the Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Additionally, it has demonstrated the capability of treating other cancers such as prostate, colon, and melanoma.