Can-Fite Announces Publication of Namodenoson Liver Cancer Study in Peer Reviewed Journal—Cancers
January 08 2021 - 7:00AM
Business Wire
- Significant 12-month overall survival benefit in the CPB7
population and 2 patients are still under treatment for more than
3.5 years
- Namodenoson is headed into a global pivotal Phase III
study
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 a scientific paper titled, “Namodenoson
in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis:
Randomized Placebo-Controlled Clinical Trial” was published in the
peer reviewed journal Cancers.
The paper highlights and analyzes results from Can-Fite’s Phase
II study, a randomized placebo-controlled trial to investigate
Namodenoson as a 2nd-line treatment for advanced hepatocellular
carcinoma (HCC) and moderate hepatic dysfunction, as defined by
Child–Pugh B (CPB) scores of 7–9. Even though the trial did not
meet its primary endpoint, in patients with a CPB score of 7,
Namodenoson was associated with a significant improvement in
12-month overall survival and 2 patients are still under treatment
for more than 3.5 years.
A pivotal Phase III study of Namodenoson as a 2nd or 3rd line
treatment in HCC CPB7 patients has been designed, and both the U.S.
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) have agreed with the protocol. Upon successful
results, the trial may lead to concurrent marketing approval in the
U.S. and Europe. Namodenoson has been granted Orphan Drug Status by
both the FDA and EMA, in addition to Fast Track Status by the FDA.
Namodenoson continues to be administered to HCC patients under a
compassionate use program in Israel.
“With the publication of this study, we believe we are advancing
the body of scientific data needed to bring a treatment to HCC
patients with Child-Pugh B7. This subset of patients with advanced
disease and borderline liver function have few, if any treatment
options. Nearly all other liver cancer studies exclude these
patients due to poor prognosis. As detailed in our published paper,
Namodenoson significantly prolonged 12-month survival in HCC CPB7
patients in our Phase II study. We are hopeful that if our planned
pivotal study produces similar results, Can-Fite will be able to
offer a much needed therapy to this population of advanced liver
cancer patients,” stated Can-Fite CEO Dr. Pnina Fishman.
Liver cancer is one of the leading causes of cancer deaths
globally, with an estimated 854,000 new cases and 810,000 deaths
annually. DelveInsight estimates the HCC drug market will reach
$3.8 billion in 2027 in the G8 countries.
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, 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
2,000 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210108005113/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Mar 2024 to Apr 2024
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Apr 2023 to Apr 2024