Can Fite BioPharma Ltd (CANF)

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Can-Fite Announces Pre-IND Submission to U.S. FDA for Piclidenoson in the Treatment of COVID-19 Infected Patients with Moderate-to-Severe Symptoms

Piclidenoson’s anti-viral, anti-inflammatory, anti-rheumatic properties and excellent safety profile make it a strong candidate for the potential treatment of COVID-19

PETACH TIKVA, Israel--(BUSINESS WIRE)-- 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 it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms. Through the pre-IND, Can-Fite anticipates receiving the FDA’s advice and guidance on its planned clinical study protocol. Following the FDA’s advice, Can-Fite plans to submit an IND application for Piclidenoson to be evaluated as a potential addition to the current standard of care treatment for COVID-19.

Piclidenoson, 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.

“We look forward to our discussions with the FDA regarding moving forward into a clinical study of Piclidenoson for COVID-19. The literature, our experience in adenosine biology, and the favorable human safety experience of the drug support the exploration of Piclidenoson as an add-on therapy to standard of care for COVID-19 patients who are hospitalized with moderate to severe symptoms,” stated Can-Fite CEO Dr. Pnina Fishman.

About Piclidenoson

Piclidenoson 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. Piclidenoson has been approved for a pilot clinical trial in Israel to treat hospitalized COVID-19 infected patients with moderate-to-severe symptoms.

About Can-Fite BioPharma Ltd.

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-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. Piclidenoson has been approved for a pilot clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms. 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.

https://finance.yahoo.com/news/fite-announces-pre-ind-submission-110000615.html