Can-Fite: Namodenoson’s Treatment of Liver Fibrosis Receives Notice of Allowance from U.S. Patent Office
March 14 2022 - 7:00AM
Business Wire
Broad patent addresses markets for the
treatment of all advanced liver fibrosis indications
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 it has received a Notice of Allowance
from the U.S. Patent and Trademark Office (PTO) for its invention
titled “Method for Treating Fibrotic Liver Tissue Using CL-IB
MECA”.
Currently, Namodenoson (CL-IB-MECA) is being developed for two
liver indications, liver cancer and NASH. The allowance granted by
the US PTO opens the door for much broader market needs which
entail all clinical conditions with advanced liver fibrosis
including autoimmune hepatitis, primary biliary cirrhosis (PBC),
nonalcoholic fatty liver disease (NAFLD), and alcoholic liver
disease (ALD) among others. The global liver disease treatment
market was valued at approximately $20 billion in 2020 by Allied
Market Research.
Can-Fite is currently enrolling patients in a Phase IIb trial of
Namodenoson for the treatment of NASH, an advanced non-alcoholic
fatty liver disease, for which there is no U.S. FDA approved
treatment. Additionally, the Company expects to commence enrollment
in a pivotal Phase III study of Namodenoson in the treatment of
advanced liver cancer (hepatocellular carcinoma CPB7).
Can-Fite’s robust IP portfolio includes patents that address
NASH and liver cancer, issued in approximately 40 countries.
Namodenoson has been out-licensed in select countries for the
treatment of NASH and liver cancer with agreements that include
upfront and milestone payments.
“This U.S. patent is a very important addition to our growing IP
portfolio in liver diseases. It is very well timed with our Phase
IIb NASH study and Phase III liver cancer trial. Both are high
value indications in which our robust patent portfolio and
Namodenoson’s safety and efficacy profile position Can-Fite for
potential additional strategic distribution deals worldwide,”
stated Can-Fite CEO Dr. Pnina Fishman.
About NASH
There is currently no U.S. FDA approved treatment for NASH, an
addressable pharmaceutical market estimated to reach $35-$40
billion by 2025 driven by increasing incidence. The U.S. National
Institutes of Health estimate the prevalence of NASH in the U.S. at
2-5% of the population. NASH is the leading cause for liver
transplants among women and second leading cause overall in the
U.S. Given the rate of increase, it is expected to become the
leading indication for liver transplants in males as well.
About HCC
Hepatocellular carcinoma (HCC) is the most common form of liver
cancer. HCC with underlying Child Pugh B7 (CPB7) is one of the most
advanced forms of liver cancer. More than 800,000 people are
diagnosed with liver cancer annually and approximately 700,000 die
of the disease each year, according to the American Cancer Society.
The HCC drug market is projected to reach $3.8 billion by 2027.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson was 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, liver, and inflammatory disease. The
Company's lead drug candidate, Piclidenoson, is currently in a
Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson,
is headed into a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver cancer, and a Phase IIb trial
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. 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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