Can-Fite BioPharma (CANF) Announces Milestones for 2018

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced its near-term milestones for 2018, including events related to the rheumatoid arthritis/psoriasis drug Piclidenoson and the liver disease drug Namodenoson.

The Company believes that it is close to reaching certain significant clinical milestones in its efforts to bring the two lead drug candidates, Piclidenoson and Namodenoson, to market. Both drug candidates are administered to patients orally in the form of a tablet and have demonstrated an excellent safety profile in prior clinical trials. The below near-term key events provide an outlook of Can-Fite's objectives and potential for increased growth.

Piclidenoson

• A pivotal Phase III study, ACRobat®, for the treatment of patients with rheumatoid arthritis is currently enrolling patients to evaluate the drug as a first line treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis.
• A pivotal Phase III study, Comfort®, for the treatment of patients with moderate-to-severe plaque psoriasis in comparison to placebo and as compared to apremilast (Otezla®) is expected to commence during 2018.Can-Fite expects that these pivotal Phase III studies will serve as the first of two pivotal studies required for European Medicines Agency (EMA) drug approval.

Namodenoson

• Top-line results from the ongoing Phase II study with Namodenoson for patients with advanced liver cancer is expected in the second half of 2018. Enrollment of all 78 subjects in Israel, Europe and the U.S. has been completed and the Company continues to follow up on patients’ overall survival.
• Phase II study in patients with NAFLD/NASH has commenced in Israel, and is expected to enroll approximately 60 patients. The Company aims to complete enrollment for this study in the next twelve months.

Biomarker

• The Company has already developed a high throughput screening assay which is conducted in a central lab for the evaluation of the A3AR Biomarker in a small blood sample withdrawn from the patients in each of the trials. The purpose of analyzing the biomarker prior to treatment is to help identify an individual patient's responsiveness to the Company's drugs, providing more personalized medicine. In case a direct correlation between biomarker level prior to treatment and patients’ response to the drug is demonstrated, the Company expects this to have additional commercial applications. The U.S. Patent and Trademark Office previously issued a patent for the utilization of A3AR as a biomarker to predict patient response to Piclidenoson in autoimmune inflammatory indications.

“We are very excited at the opportunity of potentially receiving further validation of our drug candidates, which represents significant steps forward in our commitment to delivering treatments to patients. We hope to see this come to fruition upon conclusion of our various trials,” stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite's Piclidenoson and Namodenoson are focused on multibillion-dollar market opportunities. The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet-need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

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 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 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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