Can Fite Announces First Patient Enrolled in Phase IIb NASH Clinical Trial with Namodenoson
January 31 2022 - 7:00AM
Business Wire
Namodenoson met primary endpoint in Phase
IIa NASH study by reducing liver fat, inhibiting fibrosis, and
demonstrating anti-inflammatory effect
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 enrolled the first patient in a
Phase IIb study of its drug candidate Namodenoson in the treatment
of NASH.
The Phase IIb trial is a multicenter, randomized, double-blind,
placebo-controlled study in subjects with biopsy-confirmed NASH.
The primary efficacy objective of the trial is to evaluate the
efficacy of Namodenoson as compared to placebo in 140 subjects with
NASH, as determined by a histological endpoint. Eligible subjects
are randomly assigned in a 2:1 ratio to oral doses of Namodenoson
25 mg every 12 hours or a matching placebo for 36 weeks.
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.
“Our Phase IIa study demonstrated very encouraging results based
on key liver fibrosis and NASH biomarkers. We hope to see a similar
therapeutic effect in a larger patient population as measured by
liver biopsy,” stated Can-Fite CEO Dr. Pnina Fishman.
Can-Fite has out-licensing agreements for Namodenoson in the
treatment of NASH in Eastern Europe, China, and South Korea which
include milestone payments and double-digit royalties upon approval
and commercialization.
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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version on businesswire.com: https://www.businesswire.com/news/home/20220131005278/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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