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Can-Fite: Findings Showing the Complete Clearance of Cancer in Patient Treated with Namodenoson will be Presented at the AASLD Liver Meeting Namodenoson is now in a global pivotal Phase III study for advanced liver cance

Key Takeaway: Can-Fite: Findings Showing the Complete Clearance of Cancer in Patient Treated with Namodenoson will be Presented at the AASLD Liver Meeting Namodenoson is now in a global pivotal Phase III study for advanced liver cancer PETACH TIKVA, Israel, October 25, 2022 -- Can-Fite Bi

Full Press Release Details

Can-Fite: Findings Showing the Complete Clearance
of Cancer in Patient Treated with Namodenoson will be Presented at the AASLD Liver Meeting
Namodenoson is now in a global pivotal Phase
III study for advanced liver cancer
PETACH TIKVA, Israel, October 25, 2022 -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address inflammatory, cancer and liver diseases, announced today that a poster entitled "Complete Response Induced by Namodenoson,
an A3 Adenosine Receptor Agonist, in a Patient with Advanced Hepatocellular Carcinoma" will be presented at the American Association
for the Study of Liver Diseases' (AASLD) The Liver Meeting at 1:00 pm on Monday, November 7, 2022 in Washington, D.C. The findings
are published, Abstract 4413, in the October 2022 supplement of HEPATOLOGY, a premier peer-reviewed journal in the field of liver
disease published on behalf of the AASLD.
CT images of the tumor at baseline as well
as 7 weeks and approximately 5 years after treatment initiation.
Summary of Abstract:
The patient, a 61-year-old woman with hepatocellular
carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite's
prior Phase II study. The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for 5 years
under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.
This case report demonstrates that treatment with
Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.
"A Complete Response of HCC in an advanced
stage is rare, and we are pleased to report that under treatment with Namodenoson, this patient has now survived more the five years,
returning to normal liver function with the disappearance of ascites and peritoneal carcinomatosis," stated Can-Fite CEO Dr. Fishman.
"We look forward to sharing our findings on this case with the community of hepatologists at The Liver Meeting in order to advance
scientific knowledge and bring to market safe and effective treatments for liver cancer."
Can-Fite's pivotal Phase III study in patients
with advanced liver cancer is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe.
If the study achieves its endpoint, the Company will be in a position to submit Namodenoson for approval with the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA). Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with
the FDA. A registration plan has been submitted to and accepted by the FDA.
The Liver Meeting, which takes place in Washington,
D.C. from November 4 - 8, 2022, brings together clinicians, associates, and scientists from around the world to exchange information
on the latest research, discuss new developments in liver treatment and transplantation, and network with leading experts in the field
The HCC drug market is expected to reach $3.8
billion in 2027 in the G8 countries according to DelveInsight.
Namodenoson is a small orally bioavailable drug
that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated for two indications,
as a second line treatment for hepatocellular carcinoma in a pivotal Phase III study, and as a treatment for non-alcoholic steatohepatitis
(NASH) in a Phase IIb study. 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, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver cancer. 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. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical
studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking
statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those
relating to historical facts, are "forward looking statements". 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. 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 known and unknown risks, uncertainties and other factors that may cause
Can-Fite's actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements
to differ materially from those anticipated in these forward-looking statements include, among other things, 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; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine;
risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political
and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time
to time in the "Risk Factors" section of Can-Fite's Annual Report on Form 20-F filed with the SEC on March 24, 2022
and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation
to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise,
except as may be required by any applicable securities laws.
Last updated: Oct 25, 2022