Following Pre-IND Guidance from FDA Can-Fite to Advance Piclidenoson into Phase II COVID-19 Trial in the U.S.
IND and Phase II protocol expected to be filed by end of June to evaluate COVID-19 infected patients with moderate-to-severe symptoms
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, announced today that in response to Can-Fite’s Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), the FDA has provided detailed comments regarding the prospective use of Piclidenoson to treat patients suffering from COVID-19. The FDA’s response allows Can-Fite to proceed to the next step of formally submitting an IND for Piclidenoson in this indication.
Can-Fite CEO, Dr. Pnina Fishman commented, “We are grateful for the thoughtful and comprehensive guidance from the FDA. Using the FDA’s feedback on our clinical trial, we anticipate submitting an IND shortly. We believe that 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.”
The planned Phase II trial will evaluate the efficacy and safety of Piclidenoson, when added to the current standard of care treatment, for COVID-19 infected patients with moderate-to-severe symptoms.
Piclidenoson, an A3 adenosine receptor (A3AR) agonist, has a well-established safety profile in clinical studies in the U.S. and abroad, and has been dosed in over 1,000 patients 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 have been shown to be effective in models of inflammation and sepsis.
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.
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Source: Can-Fite BioPharma Ltd.
Released June 9, 2020