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Fite BioPharma Announces New Pre-clinical Data Supporting a Novel Anti-NASH Mechanism of Action for Namodenoson
TIKVA, Israel, February 12, 2018 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company
advancing a pipeline of proprietary small molecule drugs that address liver and inflammatory diseases, announced today that pre-clinical
studies show Namodenoson's novel mechanism of action which entails de-regulation of 3 key signaling pathways which mediate
the etiology and pathology of NAFLD/NASH and are responsible for the anti-inflammatory and anti-fibrogenic effect in the liver.
studies were conducted in hepato-stellate cells in vitro and in an experimental NASH CCL4 model, showing that in both systems,
the molecular mechanism of action of Namodenoson was conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate
(PI3K) which controls 3 downstream signal transduction pathways, the Wnt, NF-kB and -SMA, which control liver inflammation
and liver fibrosis. The detailed data is scheduled to be presented at the 2018 International Liver Congress (ILC), which is the
annual meeting of the European Association for the Study of the Liver (EASL) (http://www.easl.eu/discover/events/detail/2018/the-international-liver-congress-2018).
Company is currently conducting a Phase II trial with its drug candidate Namodenoson for the treatment of 60 patients with non-alcoholic
fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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. Can-Fite's 12-week study
has been designed by leading Key Opinion Leaders in the area of NASH and liver diseases in the US including the company CAB members,
Dr. Scott Friedman, Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York; Dr. Arun
Sanayal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine; Dr.
Rifaat Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and
Dr. Stephen A. Harrison, the Medical Director of Pinnacle Clinical Research.
has been tested in over 100 subjects with other liver diseases, with clinical data suggesting a very favorable safety profile.
believe that the anti-inflammatory and anti-fibrogenic effects of Namodenoson, together with the favorable safety profile to date
make it a promising drug candidate for the treatment of NAFLD/NASH," stated Prof. Rifaat Safadi.
is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a study published
in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes.
Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced
form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect
2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little
or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH
is estimated to reach $35-40 billion.
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 is believed to account for the excellent safety profile
of the drug. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status
in the U.S. as a second line treatment for hepatocellular carcinoma.
Can-Fite BioPharma Ltd.
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 early 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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