Full Press Release Details
Announces Compelling Pre-Clinical Data on CF102 in the
Treatment of Non-Alcoholic Steatohepatitis (NASH)
patent for CF102 in the treatment of NASH
unmet need for 2-5% of U.S. population living with NASH
$35-40 billion market by 2025
FDA approved therapies currently exist
TIKVA, Israel, November 23, 2015 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with
a pipeline of proprietary small molecule drugs that address inflammatory diseases, cancer, and sexual dysfunction, today announced
development of its drug candidate CF102, which is currently in Phase II trials for hepatocellular carcinoma (HCC) the most common
form of liver cancer, will be expanded into treatment for non-alcoholic steatohepatitis (NASH).
is characterized by excess fat in the liver along with inflammation and liver damage. It resembles alcoholic liver disease; however,
it occurs in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. According to the
National Institutes of Health, NASH affects between 2% and 5% of Americans and the prevalence of NASH has been increasing,
potentially due to increasing rates of obesity and diabetes. By 2025, Deutsche Bank estimates the addressable pharmaceutical market
for NASH will reach $35-40 billion in size. As of today, while there are several companies developing drugs to treat NASH that
are in preclinical and clinical development, no specific U.S. Food and Drug Administration (FDA) approved treatment for NASH exists.
from our recently concluded preclinical study of CF102 in liver disease revealed compelling data. Based on these findings, we've
filed a patent for CF102 in the treatment of NASH," stated Can-Fite CEO Dr. Pnina Fishman. "Because the prevalence
of NASH continues to grow and no treatment currently exists, our data support the development of CF102 for the treatment of NASH."
its capability to improve liver pathology in a NAFLD (non-alcoholic fatty liver disease)/diabetes animal model of NASH. The data
prior preclinical studies, CF102 has shown efficacy in the treatment of liver regeneration and function following liver surgery.
Can-Fite currently has a U.S. Investigational
New Drug (IND) application active with the U.S. FDA for CF102. CF102 is currently being evaluated as a second-line treatment for
HCC through a global Phase II trial. Can-Fite has received Orphan Drugs Designation for CF102 for this indication in Europe and
the U.S., as well as Fast Track Status in the U.S. Data from the Phase II HCC study is expected in 2016.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is
highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent
safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect
via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE MKT: 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 is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced
psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation
in the U.S. and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and
Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.
The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program
for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile
with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.
press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other
things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition,
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from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized
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
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