Can-Fite BioPharma Ltd. (NYSEAMERICAN:CANF) has announced the FDA gas offered detailed comments in response to its Pre-Investigational New Drug filling. The IND is for the possible use of Piclidenoson in the treatment of COVID-19 patients.
Can-Fite to file IND application for Piclidenoson in COVID-19 treatment
The response from the FDA allows the company to go on with the process of submitting an IND for Piclidenoson for the treatment of COVID-19. The company’s CEO, Pnina Fishman, indicated that the company was grateful for the comprehensive and thoughtful guidance it received from the agency. He added that using the guidance from the FDA for its clinical trial, the company is planning to submit an IND soon. Pnina indicated that they are optimistic that the drug’s anti-inflammatory, antiviral, anti-rheumatic as well as good safety profile make Piclidenoson a strong potential COVID-19 treatment candidate.
The expected second phase trial will evaluate the safety and efficacy of Piclidenoson in combination with standard of care treatment in g COVID-19 patients showing moderate to severe symptoms. Piclidenoson is an A3 adenosine receptor agonist (A3AR) that has shown an excellent safety profile in clinical trials. A3AR is a potent anti-inflammatory agent when used with other standards of care treatments in acute infectious diseases where there are overwhelming host defense responses.
Can-Fite receives guidance from EMA regarding Namodenoson trial
The company has also announced a meeting with the EMA’s Scientific Advice Working Party (SAWP) about the third-phase development of Namodenoson in treating hepatocellular carcinoma (HCC) the most common liver cancer form. Namodenoson is an A3AR agonist that has recently demonstrated significant average overall survival in a select population of patients with HCC in the second phase trial.
The company sought SAWP guidance to complement previous guidance from the US FDA in its end-of-phase meeting about plans for the third phase registration study. Following the completion of the meeting with the EMA the company now has adequate regulatory input to carry out the registration trial as per the requirements of the European Union and the US.