Full Press Release Details
Can-Fite Updates on Status
of Phase II Advanced Liver Cancer Trial
PETACH TIKVA, Israel, June 19, 2018 --
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
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
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.
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
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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
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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
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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.