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Can-Fite Reports on New Pre-clinical Developments with its NASH Drug Namodenoson Robust anti-NASH effects when drug is administered orally Data support the selection of the primary endpoint for the ongoing Phase II study

Key Takeaway: Can-Fite Reports on New Pre-clinical Developments with its NASH Drug Namodenoson Robust anti-NASH effects when drug is administered orally Data support the selection of the primary endpoint for the ongoing Phase II study Enrollment for the Phase II study is expected to be

Full Press Release Details

Can-Fite Reports on New Pre-clinical
Developments with its NASH Drug Namodenoson
Robust anti-NASH effects when drug is administered orally
Data support the selection of the primary endpoint for the ongoing Phase II study
Enrollment for the Phase II study is expected to be completed by the end 2018; data release expected in H1/2019
TIKVA, Israel, June 11, 2018 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company
advancing a pipeline of proprietary small molecule drugs that address inflammatory and liver diseases, today provided an update
on new pre-clinical data supporting the selection of the primary endpoint for the current ongoing Phase II study in NAFLD/NASH
The data came out of a recently signed
collaborative research agreement with Hadassah Medical School, directed by Rifaat Safadi, M.D., Head of the Liver Unit, Gastroenterology
and Liver Diseases, Division of Medicine at Hadassah Medical Center and Professor of Internal Medicine, Bowel, Liver Disease, and
Metabolic Syndrome at Hebrew University in Israel.
In an experimental non-alcoholic steatohepatitis
(NASH) CCL4 model, Namodenoson had a highly significant effect against inflammation, necrosis, fibrosis and biliary hyperplasia,
while treating the animals orally with the drug. More specifically, the liver enzymes ALT and AST were dramatically reduced and
reversed to normal values upon treatment of the NASH bearing animals with Namodenoson. Further studies on the molecular mechanism
of action are ongoing.
Dr. Safadi commented: "These data
are very encouraging in light of the fact that the drug has been administered orally and induced robust effect on liver enzyme
levels." Dr. Safadi added that "ALT is the primary end point of the current ongoing Phase II study based on former
pre-clinical data and the current results support and strengthen our belief that we will be able to see similar data in the patients".
The detailed data has been submitted for
presentation at the American Association for the Study of Liver Diseases (AASLD) annual conference, The Liver Meeting in San
Francisco, Moscone Center California, USA to be held on November 9-13, 2018.
The current Phase II study is currently
ongoing in Israel and aimed at the enrollment of 60 patients who suffer from NAFLD/NASH with evidence of active inflammation. The
patients are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo for 12 weeks. The primary end point of the
Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include
percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The Company anticipates the completion of patient
enrollment toward the end of 2018 and data release in the first half of 2019.
Recent safety data showed that Namodenoson
has a favorable profile and lack of hepatotoxicity in patients.
There is currently no U.S. FDA approved drug for the treatment
of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications,
as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential
effect accounts for the excellent safety profile of the drug.
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 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
in 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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or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial
condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have
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Many factors could cause Can-Fite's actual activities or results to differ materially from the activities and results anticipated
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our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability
to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other
product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete
our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other
regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates;
our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business
model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain
for intellectual property rights covering our product candidates and our ability to operate our business without infringing the
intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the
political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite's filings
with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values
are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation
to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
Last updated: Jun 11, 2018