New Positive Data from Can-Fite’s Liver Cancer Phase II Clinical Study with Namodenoson
February 22 2021 - 7:10AM
Business Wire
Overall survival of nearly 4 years in two
patients with disappearance of ascites, normal liver function, and
good quality of life
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company with a pipeline of proprietary small molecule
drugs that address inflammatory, cancer and liver diseases, today
announced new data from the Phase II advanced liver cancer study
including overall survival of nearly 4 years in two patients who
are under namodenoson treatment. Additional findings show
disappearance of ascites, normal liver function and good quality of
life. In one patient stable disease has been recorded with
disappearance of peritoneal carcinomatosis. Namodenoson continues
to demonstrate a good safety profile and is well tolerated with no
severe adverse events reported.
Recently, the Company successfully concluded End-of-Phase II
meetings with the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA). Both agencies agreed with
Can-Fite’s proposed pivotal Phase III trial design of Namodenoson
for the treatment of patients with advanced hepatocellular
carcinoma (HCC), with underlying Child Pugh B7 (CPB7) cirrhosis to
support a New Drug Application (NDA) submission and approval. The
trial is expected to enroll 450 patients through multiple centers
worldwide. Namodenoson has Orphan Drug Designation for HCC in the
U.S. and Europe, has Fast Track Status in the U.S., and is
currently treating liver cancer patients through a compassionate
use program in Israel.
“We are very pleased to see prolonged survival, good quality of
life, and in particular clearance of peritoneal carcinomas in these
two patients. The FDA and EMA gave a green light to one pivotal
Phase III study which, upon positive conclusion, would lead to
registration of Namodenoson for the treatment of this devastating
disease. To our knowledge, Can-Fite is the only company developing
a drug for this advanced patient population defined as Child Pugh
B7 (CPB7) cirrhosis,” 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 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
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/20210222005458/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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