Market Overview

Top Line Results of the Namodenoson Phase II Advanced Liver Cancer Trial Expected by End of Year

  • Namodenoson seeks to address a major unmet need for Child Pugh B
    patients with advanced liver cancer
  • Namodenoson has received Fast Track Status in the U.S. and Orphan
    Drug Designation in Europe and the U.S.

BioPharma Ltd
. (NYSE: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 of drug candidate Namodenoson
(CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in
patients whose disease has progressed on sorafenib therapy. Top line
efficacy results are expected by end of 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.

Advanced liver cancer is categorized into 3 subclasses including Child
Pugh A, mostly treated with Nexavar, Child Pugh B and Child Pugh C.
Although a few drugs for the treatment of advanced liver cancer have
recently launched, none are specifically aimed at treating patients who
have reached the Child Pugh B stage. This represents a major unmet need
and potentially positions Namodenoson as an important drug candidate to
treat this patient population.

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, 22 completed at least 12 cycles of treatment (each
cycle is 28 days of treatment), of whom 5 completed 24 cycles. The
longest-treated subject has been receiving study medication for over 3

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.

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. We believe a major advantage of
Namodenoson stems from its favorable safety profile demonstrated thus
far, in which Namodenoson selectively targets diseased cells while
sparing normal cells which express very low levels of the A3 receptor.

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

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE: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, 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:

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