Can-Fite Updates on Status of Phase II Advanced Liver Cancer Trial
June 19 2018 - 7:00AM
Business Wire
- Accumulated safety data to date
continues to indicate a favorable drug safety profile without
hepatotoxicity
- Namodenoson has an Orphan Drug
Designation in Europe and the U.S., as well as Fast Track Status in
the U.S.
Can-Fite BioPharma Ltd. (NYSE American: 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) in patients whose disease
has progressed on sorafenib therapy. Can-Fite anticipates analyzing
the results of this important trial before the end of the current
year.
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.
The trial first opened to enrollment in December 2014 and
enrollment of 78 patients was completed in August 2017. While the
trial continues treating subjects in a blinded fashion (either
Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of
the 78 subjects originally enrolled, 19 completed at least 12
cycles of treatment (each cycle is 28 days of treatment) of which
three completed at least 24 cycles. The longest-treated
subject has been receiving study medication for approximately 3
years.
Accumulated safety data to date continues to indicate a
favorable safety profile, with no clinically significant novel or
emerging events attributed to chronic treatment with
Namodenoson.
Michael Silverman, MD, FACP, Can-Fite’s Medical Director says,
“While the final analysis of this trial, based on survival, has
been delayed past our original projections, we are very happy that
the reason for this is the unexpected longevity of patients
enrolled into this trial. Historically, HCC patients who have
failed treatment with sorafenib and are Child Pugh B, have very
limited life expectancy. Although the trial data are still blinded,
we are encouraged by the unexpectedly long survival for some
patients and hope that this will translate into a survival
advantage for the Namodenoson group over the placebo group, and a
critical advance for treating patients with HCC.”
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. (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 a Phase III trial for rheumatoid arthritis and is
expected to enter a Phase III trial for psoriasis in 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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