Can-Fite Granted Key NASH Patent in Israel
May 16 2022 - 7:00AM
Business Wire
Phase IIb NASH study is currently enrolling
patients; Phase IIa met endpoints including reduced liver fat
content
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, today announced that its patent titled "An A3 Adenosine
Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has
been granted by the Israel Patent Office.
This patent has been issued in approximately 40 countries and
territories including Japan, South Korea, Hong Kong, Mexico, and in
the European Union. It addresses the use of the A3 Adenosine
Receptor (A3AR) ligand, the target receptor for Can-Fite's drug
platform technology, for the treatment of ectopic fat accumulation
particularly in fatty liver as manifested in non-alcoholic fatty
liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The
treatment of NASH is a market estimated to reach $35 billion by
2025.
Can-Fite is currently enrolling and treating patients in a Phase
IIb NASH study of its liver drug candidate Namodenoson. The
multi-center, randomized, double blind, and placebo controlled
study of biopsy-confirmed NASH patients will measure efficacy
periodically through biomarkers, with a primary efficacy endpoint
determined by liver biopsy at the end of the treatment period. In a
prior Phase IIa study, Namodenoson met endpoints including reduced
liver fat content, anti-inflammatory effects, and decreased body
weight with excellent safety.
“The treatment of NASH is an enormous unmet need that Can-Fite
seeks to meet through our advanced stage clinical trial and our
expanding patent estate for the use of our target A3AR in the
treatment of fatty liver disease,” stated Can-Fite CEO Dr. Pnina
Fishman.
About Namodenoson
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 a pivotal Phase III trial as a
second line treatment for hepatocellular carcinoma, and in a Phase
IIb trial as a treatment for 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, liver, and inflammatory disease. The
Company's lead drug candidate, Piclidenoson has completed
enrollment in a Phase III trial for psoriasis. Can-Fite's liver
drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of non-alcoholic steatohepatitis (NASH), and enrollment
is expected to commence in a Phase III trial for hepatocellular
carcinoma (HCC), the most common form of liver cancer. 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. These
drugs have an excellent safety profile with experience in over
1,500 patients in clinical studies to date. For more information
please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite’s expectations, beliefs 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 made or may make
forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words
such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or
“anticipate” or their negatives or other variations of these words
or other comparable words or by the fact that these statements do
not relate strictly to historical or current matters. These
forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or
with the approval of one of Can-Fite’s authorized executive
officers. Forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they
are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to
risks and uncertainties that could cause Can-Fite’s actual results
to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause
Can-Fite’s actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ
materially from those expressed or implied in such forward-looking
statements include, but are not limited to: our history of losses
and needs for additional capital to fund 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 impact of the COVID-19 pandemic; 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.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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