Findings from Can-Fite’s Phase II Liver Cancer Study were Presented at ASCO Annual Meeting Late-Breaking Session

Phase III study protocol for Namodenoson in the treatment of advanced
liver cancer patients is now being prepared and will be presented to FDA
in an End of Phase II meeting

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite
BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company
with a pipeline of proprietary small molecule drugs that address cancer,
liver and inflammatory diseases, announced today that data from its
recently completed Phase II trial in patients with hepatocellular cancer
(HCC), the most common form of liver cancer, was presented at the
late-breaking abstract session of the 54^th Annual Meeting of
the American Society of Clinical Oncology (ASCO), the world’s largest
clinical cancer research meeting.

Prof. Salomon M. Stemmer, Principal Investigator of Can-Fite’s Phase II
trial, delivered the presentation on Sunday June 2, 2019 at the
Developmental Immunotherapy and Tumor Immunobiology session. The
presentation is entitled: “A phase II, randomized, double-blind,
placebo-controlled trial evaluating efficacy and safety of namodenoson
(CF102), an a3 adenosine receptor agonist (A3AR), as a second-line
treatment in patients with Child-Pugh B (CPB) advanced hepatocellular
carcinoma (HCC).” While the Phase II study did not achieve its primary
endpoint of overall survival in the whole population (n=78), superiority
in overall survival was found in the largest study subpopulation of
patients who were classified Child Pugh B7 (n=56) based on severity of
disease compared to the placebo treated group. Median survival in the
Namodenoson group (n = 34) was 6.8 months, versus 4.3 months for the
placebo group (n = 18) (Hazard Ratio = 0.77, p = 0.40). (See Figure 1 )

The most impressive finding was that 44% of the patients with Child Pugh
B7 treated with Namodenoson were alive at one year compared to 18% in
the placebo group. In the overall patient population, among patients who
had at least one assessment post baseline, disease control was
significant in the Namodenoson group, 26% versus 10% in the control
group after four months of treatment, P value 0.013. Among the other
positive findings that were presented is the 9% partial response in the
Namodenoson treated group vs. 0% in the placebo group. An example of a
patient demonstrating an excellent tumor shrinkage was presented. (See
Figure 2)

A3AR expression level at baseline was 1.98±0.36 in comparison to 1 unit
in healthy subjects and was not changed substantially during the
treatment period, demonstrating that continuous treatment with
Namodenoson does not result in de-sensitization or loss of the target.
Consistent with its previously demonstrated favorable safety profile,
Namodenoson showed an adverse event profile that was comparable to that
of placebo.

“No systemic therapies have shown clinical benefit in Child Pugh B
patients with advanced HCC, underscoring the importance of developing an
effective drug to serve this unmet medical need,” stated Can-Fite CEO
Pnina Fishman. “We believe evidence of Namodenoson’s efficacy to prolong
life in Child Pugh B7 liver cancer patients, without any deterioration
in quality of life due to the drug’s strong safety data, make it a
promising anti cancer agent to be moved into Phase III. We were pleased
that ASCO selected Prof. Stemmer’s presentation so he could share these
important findings at ASCO with the world’s leading clinical cancer
researchers and physicians.”

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.

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where securities values are highly volatile and may be influenced by
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Contacts

Can-Fite BioPharma
Motti Farbstein
[email protected]
+972-3-9241114