Can-Fite To Initiate Phase IIb NASH Study with its Drug Candidate Namodenoson
June 02 2021 - 7:35AM
Business Wire
A prior Phase IIa clinical trial has been
successfully concluded and met study end points
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 clearance from the
Israeli Ministry of Health to commence a Phase IIb study of its
drug candidate Namodenoson in the treatment of NASH. Can-Fite
expects to commence enrollment in Q3 2021, ahead of the prior
expected start date of Q4 2021. The Company expects to expand the
study at additional clinical sites in Europe. A prior Phase IIa
clinical trial of Namodenoson in the treatment of NASH met study
endpoints showing anti-steatotic, anti-inflammatory, and
anti-fibrotic effects.
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
will be randomly assigned in a 2:1 ratio to oral doses of
Namodenoson 25 mg every 12 hours or a matching placebo every 12
hours for 36 weeks.
“We are very pleased to receive the Israeli Ministry of Health’s
approval to proceed with our Phase IIb NASH study. Namodenoson has
the potential to offer a safe and effective treatment for NASH with
the aim of reducing liver transplants and improving quality of life
and longevity for patients,” stated Can-Fite CEO Dr. Pnina
Fishman.
NASH is a clear and urgent unmet medical need, as there
currently is no U.S. approved drug to treat the disease. As of
2016, NASH was the leading cause for liver transplants among women
and second leading cause for liver transplants overall. NASH is
expected to become the leading indication for liver transplants in
males as well. The NIH estimates the incidence of NASH in the U.S.
at 2-5% of the population. Incidence is increasing based on rising
obesity rates. By 2025, the addressable pharmaceutical market for
NASH is estimated to reach $35-40 billion.
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, inflammatory disease and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for psoriasis and a Phase II study
in the treatment of moderate COVID-19. 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
successfully achieved its primary endpoint in a Phase II 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/20210602005577/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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