Can-Fite's Piclidenoson Mechanism of Action in Psoriasis Published in 'Journal of Immunology Research'

Phase III Psoriasis Study Scheduled for Initiation During this Quarter

Psoriasis Therapeutic Market is Estimated to Reach $11.4B in 2020

Can-Fite BioPharma Ltd. CANF CFBI, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, today announced the publication of a paper entitled "Inhibition of IL-17 and IL-23 in Human Keratinocytes by the A3 Adenosine Receptor Agonist Piclidenoson" in the Journal of Immunology Research, a peer-reviewed, online open access journal.

The paper presents pre-clinical data that have been accumulated and reported earlier, demonstrating that Piclidenoson mechanism of action is manifested by the inhibition of two inflammatory cytokines, interleukin 17 (IL-17) and interleukin 23 (IL-23) which are known to play a major role in the inflammatory process of psoriasis. Currently, some of the novel biologic drugs on the market to treat psoriasis are injectable immune-modulators, which block IL-17 and IL-23. These systemic drugs offer good efficacy, however, as biologics they can cause serious side effects. The psoriasis therapeutic market is estimated to reach $11.4B in 2020 according to Visiongain.

Piclidenoson binds to the Gi protein associated A3 adenosine receptor (A3AR), which is over-expressed in psoriasis patients. This binding action has shown to induce a robust anti-inflammatory effect by inhibiting IL-17 and IL-23 as demonstrated in the in-vitro studies presented in the paper. An orally administered small molecule drug, Piclidenoson, potentially offers safety superior to biologics as shown in clinical studies in more than 1,000 people.

The paper can be accessed online at: https://www.hindawi.com/journals/jir/aip/2310970/.

The Company has completed the preparatory work for its COMFORT Phase III Psoriasis study, designed to evaluate the efficacy and safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla^®) and placebo in around 400 patients with moderate-to-severe plaque psoriasis. The study will be conducted in 5 countries in Europe, Israel and Canada. The study protocol has been already submitted to the IRB in Israel, which will be the first country and patient enrollment is scheduled to be initiated this quarter. Submissions in Europe and Canada will follow shortly.

Pnina Fishman, PhD., Can-Fite CEO commented, "We believe this pre-clinical study provides a strong rationale for the use of Piclidenoson in patients suffering from psoriasis. We look forward to initiating our Phase III study this quarter."

About Piclidenoson (CF101)

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 including rheumatoid arthritis (Phase III, ongoing) and psoriasis (Phase III to be initiated shortly).

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. CANF CFBI is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis during the second quarter of 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and 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 in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

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