Can-Fite Submits Liver Cancer Phase III Protocol and Registration Plan to EMA for Namodenoson
13 Februar 2020 - 1:00PM
Business Wire
- Can-Fite successfully concluded its End-of-Phase II meeting
with the U.S. FDA recently
- One Phase III trial for concurrent regulatory approval in
U.S. and Europe upon successful study results
- Namodenoson has Orphan Drug and Fast Track status,
addressing projected $3.8 B market
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a
biotechnology company with a pipeline of proprietary small molecule
drugs that address inflammatory, cancer and liver diseases,
announced today it has submitted the study’s protocol design and
registration plan for its pivotal Phase III liver cancer trial to
the European Medicines Agency’s (EMA) Committee for Medicinal
Product and Human Use (CHMP). The Phase III pivotal trial will
evaluate the efficacy of its drug candidate Namodenoson in patients
with advanced hepatocellular carcinoma (HCC), with underlying Child
Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line
therapy
The filing with the EMA follows Can-Fite’s successful conclusion
of its End-of-Phase II meeting with the U.S. Food and Drug
Administration (FDA), in which the FDA agreed with Can-Fite’s
proposed pivotal Phase III trial design to support a New Drug
Application (NDA) submission and approval of Namodenoson in the
treatment of HCC.
“Having submitted our study design to both U.S. and European
regulators, we look forward to initiating this Phase III study.
Should Namodenoson meet the study’s primary endpoint of improved
overall survival for liver cancer patients, then we intend to file
for concurrent approval of our drug in both the U.S. and Europe,
two of the largest healthcare markets in the world,” stated
Can-Fite CEO Dr. Pnina Fishman.
DelveInsight estimates the HCC drug market will reach $3.8
billion in 2027 in the G8 countries. According to the American
Cancer Society, in the U.S. liver cancer incidence has tripled
since 1980, with an estimated 42,000 cases diagnosed and 32,000
deaths annually. Incidence of liver cancer is much higher in other
countries, with more than 800,000 diagnoses and 700,000 deaths
estimated globally each year.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson is being evaluated as a second line treatment for
hepatocellular carcinoma, with a recently completed Phase II trial
and planned Phase III trial in this indication. The drug is
currently in an ongoing Phase II trial 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, inflammatory disease and sexual
dysfunction. The Company's lead drug candidate, Piclidenoson, is
currently in Phase III trials for rheumatoid arthritis and
psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently
completed a Phase II trial for hepatocellular carcinoma (HCC), the
most common form of liver cancer, and is 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 in
preclinical studies and the Company is investigating additional
compounds, targeting A3AR, for the treatment of sexual dysfunction.
These drugs have an excellent safety profile with experience in
over 1,000 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 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/20200213005370/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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