Can-Fite Reports on the Progress of Its Phase II Liver Cancer with Namodenoson
18 December 2017 - 11:00PM
Business Wire
- Accumulated safety data to date
indicate potential favorable drug safety profile without
hepatotoxicity
- Company anticipates data release to
occur in 2H2018
Can-Fite BioPharma Ltd. (NYSEAM:CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, today provided an update on its Phase II clinical trial
with drug candidate Namodenoson (CF102) in the treatment of
advanced hepatocellular carcinoma (HCC). Ongoing close observation
of enrolled subjects indicates a potentially favorable drug safety
profile. The Company previously announced in August that it had
successfully completed enrollment of 78 patients.
The global Phase II study is being conducted in the U.S., Europe
and Israel. Patients with advanced HCC, Child Pugh B, who failed
Nexavar (sorafenib) as a first line treatment are treated twice
daily with 25 mg of oral Namodenoson or placebo using a 2:1
randomization. The primary endpoint of the Phase II study is
Overall Survival (OS). Secondary endpoints include Progression Free
Survival (PFS), safety, and the relationship between outcomes and
A3AR expression.
Although the trial remains blinded to the Company, accumulated
safety data to date indicate a potentially favorable drug safety
profile without hepatotoxicity and possible positive clinical
effects. There are now subjects treated for more than one year and
in some cases, two years. To date, 15 subjects have completed at
least 12 cycles of treatment (each cycle is 28 days of treatment)
of which two completed 24 cycles. The Company anticipates data
release to occur in 2H2018.
Can-Fite CEO Dr. Pnina Fishman commented, “We are pleased with
the progress so far in our clinical trial for Namodenoson for the
treatment of advanced HCC, the third leading cause of cancer deaths
worldwide, and look forward to data release later in 2018.”
Can-Fite received Orphan Drug Designation for Namodenoson in
Europe and the U.S., as well as Fast Track Status in the U.S. as a
second line treatment for HCC.
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 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. (NYSEAM:CANF) (TASE:CFBI) is an advanced
clinical stage drug development Company with a platform technology
that is designed to address multibillion-dollar markets in the
treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is currently in a
Phase III trial for rheumatoid arthritis and is expected to enter a
Phase III trial for psoriasis in early 2018. Can-Fite's liver
cancer drug, Namodenoson, is in Phase II trials for hepatocellular
carcinoma (HCC), the most common form of liver cancer, and 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: 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 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; estimates of our expenses,
future revenues, capital requirements and our needs for additional
financing; 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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Can-Fite BioPharmaRobert Haag(800)
716-4880IR@canfite.co.ilcanf@irthcommunications.com
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