Can-Fite Gears Up to Initiate Pivotal Phase III Liver Cancer Study
July 08 2021 - 7:00AM
Business Wire
FDA Granted Namodenoson Orphan Drug and Fast
Track Status
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 completed preparatory work ahead
of the anticipated initiation of patient enrollment for its pivotal
Phase III registration trial of Namodenoson in the treatment of
hepatocellular carcinoma (HCC), the most common form of liver
cancer.
Can-Fite has received agreement from both the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) on the
protocol and plans to submit it for Institutional Review Board
(IRB) approvals in the coming weeks. Namodenoson has Orphan Drug
status with both the FDA and EMA, as well as Fast Track Status with
the FDA for the treatment of HCC. A compassionate use program has
been ongoing in Israel.
The double blind, placebo-controlled trial will enroll 450
patients diagnosed with HCC and underlying Child Pugh B7 (CPB7)
through clinical sites worldwide. Patients will be randomized to
oral treatment with either 25 mg Namodenoson or matching placebo
given twice daily. The primary efficacy endpoint of the trial is
overall survival. Other oncology trial efficacy outcomes such as
tumor radiographic response rates and median progression-free
survival, as well as standard safety parameters, will be
assessed.
The Company plans to conduct an interim analysis by an
Independent Data Monitoring Committee (IDMC) after 50% of enrolled
patients are treated. Namodenoson will be evaluated as a 2nd or 3rd
line treatment for CPB7 patients in whom other approved therapies
have not been or are no longer effective.
“We are eager to commence this study, as there is a dire need
for a safe and effective treatment for patients with advanced liver
disease, defined as CPB7, where Namodenoson has an advantage with
its liver protective effect,” stated Can-Fite CEO Dr. Pnina
Fishman.
According to the American Cancer Society, liver cancer accounts
for more than 700,000 deaths globally each year. HCC is commonly
aggressive with poor survival rates. As new drugs that effectively
and safely treat HCC are developed and approved, the market for HCC
treatments is estimated by Delveinsight to reach $3.8 billion by
2027 for 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210708005319/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