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Due to Patient Survival Top line Results of the Namodenoson Phase II Advanced Liver Cancer Trial Expected Q1/19 Namodenoson seeks to address a major unmet need for Child Pugh B patients with advanced liver cancer Namoden

Key Takeaway: to Patient Survival Top line Results of the Namodenoson Phase II Liver Cancer Trial Expected Q1/19 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 Des

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to Patient Survival Top line Results of the Namodenoson Phase II
Liver Cancer Trial Expected Q1/19
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.
TIKVA, Israel, October 31, 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 of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC)
in patients with Child Pugh B whose disease has progressed on sorafenib therapy. Due to patient survival, top line efficacy results
are expected during the first quarter of 2019.
of 78 patients was completed in August 2017 and the trial continues treating subjects in a blinded fashion (either Namodenoson
25 mg BID or matching placebo).
statistical plan for this trial requires that the primary efficacy analysis occurs when no more than 3 of the original 78 patients
survive. At the outset of the trial, it was assumed that patients with advanced HCC with Child-Pugh B had a relatively poor prognosis,
and that within approximately a year of enrollment of the last subject, primary efficacy analysis could be conducted. In order
to maintain the statistical integrity of the trial as well as adhere to the principles of Good Clinical Practice, the Company
estimates that it will un-blind the data during Q1/19.
CEO, Dr. Pnina Fishman, commented, "This unexpectedly prolonged longevity is unquestionably beneficial for the individual
patients, and gives us hope that Namodenoson may eventually prove its value in this patient population."
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.
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.
Can-Fite BioPharma Ltd.
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, 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.
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: our history of losses and needs for additional capital to fund our operations and
our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working
capital needs; 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 strategic partnerships and other 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; 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.
Last updated: Oct 31, 2018