Can-Fite Announces Phase II Advanced Liver Cancer Top-Line Results for its Orphan/Fast Track Drug Namodenoson

• The study did not achieve its primary end point of median overall
  survival in the whole population of 78 patients, however, superiority
  in median overall survival was found in the largest study
  subpopulation of 56 patients and in secondary end points including
  objective response in the whole population, strongly supporting the
  progression into Phase III.
• Dr. Josep Llovet, a Key Opinion Leader in the field of liver
  cancer, said: “Considering that patients with advanced HCC and severe
  liver dysfunction do not have any accepted standard of care, the
  current data from this Phase II trial suggest a signal of efficacy
  that supports continuing the development of Namodenoson with a Phase
  III study in this population.”
• Dr. Salomon Stemmer, the Israeli principal investigator, added:
  “Given the evidence of clinical benefit of Namodenoson, I plan on
  offering it to selected HCC CPB patients with the drug in the
  compassionate use setting.”

Conference call with management scheduled for today, Tuesday March 26
at 8.30 a.m. Eastern time

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 the Phase II
advanced liver cancer study did not achieve its primary end point of
overall survival in the whole population (n=78). At the same time,
superiority in overall survival was found in the largest study
subpopulation of CPB7 (n=56) and in secondary end points in the whole
population, including objective response measured by CT or MRI. These
data strongly support the progression into Phase III.

Advanced liver cancer in patients with underlying cirrhosis is
categorized into three subclasses based on the severity of cirrhosis,
starting with Child Pugh A (CPA), mostly treated with Nexavar^®
and progressing to Child Pugh B (CPB) and Child Pugh C (CPC),
for which there are no drugs on market with proven efficacy.

In the study, the Company enrolled only patients with CPB stage liver
cancer with CBP stage patients being further divided into three
categories of increasing severity, namely CPB7, CPB8, and CPB9. These
patients already failed first line Nexavar and were treated with
Namodenoson (25mg), or placebo, as a second line treatment, twice daily,
using a 2:1 randomization. The primary endpoint of the study was defined
as the length of time the patients lived after receiving treatment or
median overall survival (OS). Secondary endpoints included
safety, the length of time tumors did not grow after treatment, or
progression free survival (PFS), the percent of patients whose
tumors partially shrank after treatment, or partial response (PR),
and the percent of patients who were PR or stable, or disease control
rate (DCR).

Findings from the study include the following:

Dr. Llovet, a Founder and Director of the Liver Cancer Program and Full
Professor of Medicine at the Mount Sinai School of Medicine, New York
University, and Professor of Research-ICREA in the BCLC Group, Liver
Unit, IDIBAPS-Hospital Clínic, University of Barcelona, stated, “The
global incidence of liver cancer continues to increase and has more than
tripled in the United States over the last three decades, and currently
there are no recommended systemic treatment options for patients with
advanced HCC and severe liver dysfunction (Child Pugh B).” Dr. Llovet
added, “Considering that patients with advanced HCC and severe liver
dysfunction do not have any accepted standard of care, the current data
from this Phase II trial suggest a signal of efficacy that supports
continuing the development of Namodenoson with a Phase III study in this
population. I will be happy to help with the design of the Phase III and
serve as the principal investigator of the trial.”

Dr. Salomon M Stemmer, Institute of Oncology, Davidoff Center, Rabin
Medical Center, Petah Tikva/Sackler Faculty of Medicine, Tel Aviv
University, Israel and the study principal investigator, added, “Given
the evidence of Namodenoson’s clinical benefit, I plan on offering it to
selected HCC CPB patients in the compassionate use setting.”

“We are encouraged by the advantage shown by Namodenoson in the CPB7 HCC
population, a group for which there are no drugs with proven
effectiveness,” stated Pnina Fishman, Chief Executive Officer of
Can-Fite. “Since Namodenoson has a favorable safety profile and shows no
evidence of hepatotoxicity, it may possess a unique therapeutic index in
this high-need population. Given that Namodenoson has been granted Fast
Track status by the FDA, we look forward to engaging regulatory
authorities in a dialog at the earliest opportunity.”

An abstract for the late-breaking session has been submitted to The
American Society of Clinical Oncology (ASCO) annual meeting, to take
place May, 2019 in Chicago, IL, USA.

Conference Call

The Company’s management will host a conference call today at 8:30 a.m.
Eastern time to discuss the results of the Phase II advanced liver
cancer trial. To participate in the conference call, please dial
877-705-6003 (domestic) or 201-493-6725 (international) or 1 809 406 247
in Israel, five minutes prior to the start of the call and provide the
Conference ID: 13689112. Investors may also listen via webcast at: http://public.viavid.com/index.php?id=133770.
A replay of the webcast will be available shortly after the conclusion
of the call and archived on the Company’s website for 90 days following
the call.

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 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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Contacts

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