Full Press Release Details
Can-Fite: Namodenoson Significantly Inhibits
Pancreatic Cancer in Preclinical Studies-A Patent Has Been Filed
PETACH TIKVA, Israel,
January 24, 2023 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company
advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that its
anti-cancer drug Namodenoson significantly inhibits the growth of pancreatic carcinoma as a stand-alone treatment. In combination with
the leading chemotherapy used in pancreatic cancer, gemcitabine, Namodenoson demonstrated a significant additive effect. These pre-clinical
studies were conducted on advanced pancreatic carcinoma patient cells. Namodenoson's molecular mechanism of action in pancreatic
cancer involves the regulation of the NF- B /I B /STAT3-mediated pathway.
Namodenoson is currently being evaluated in a
pivotal Phase III study in advanced liver cancer and has completely cleared cancer in an advanced liver cancer patient who remains cancer-free
6 years after starting treatment.
"Following Namodenoson's successful
results in advanced liver cancer, we continue to develop our oncology drug for the treatment of additional aggressive tumors including
pancreatic cancer. There is a dire need for a safe and effective treatment for patients with pancreatic carcinoma where Namodenoson has
an advantage due to its protective effects on the cardiovascular system, liver, and bone marrow," stated Can-Fite CEO Dr. Pnina
Fishman "Our pre-clinical Namodenoson studies in pancreatic cancer, combined with the clinical data from liver cancer, may open
the door for an effective and safe treatment in this devastating disease which accounts for nearly a half-million diagnoses and deaths
Based on these findings, Can-Fite has filed a
patent application that covers the use of Namodenoson for the treatment of pancreatic cancer.
The highest incidence
rates for pancreatic cancer are in Asia, Europe, and North America. According to the American Society of Clinical Oncology (ASCO), in
2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally and an estimated 466,000 died from the disease. The 5-year
survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen Research estimates the
global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected to grow to approximately
$6.6 billion by 2030.
Namodenoson is a small orally bioavailable drug
that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was 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: CANF) 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
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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.