Full Press Release Details
Can-Fite's Phase III Psoriasis
Study to Complete 16-Week Treatment of Last
Patient in January; Topline Data Expected Q1 2022
Piclidenoson is seeking to address $11 billion
psoriasis market in need of treatments with minimal-to-no side effects
PETACH TIKVA, Israel, December 7, 2021 -- 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, today announced the last of approximately 400 psoriasis patients enrolled in its Phase
III Comfort study is scheduled to complete a 16-week cycle of treatment
with Piclidenoson, the Company's lead drug candidate, at the beginning of January 2022. The 16-week treatment period is the primary
endpoint of the study, and the Company expects to announce topline results during Q1 2022.
Piclidenoson is a novel, first-in-class, A3 adenosine
receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical
The randomized, double blind, active and placebo
controlled study is being conducted in Europe, Israel, and Canada. The study's primary endpoint is the proportion of patients who
achieve a PASI score response of 75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla
in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of A3AR, Can-Fite's therapeutic
"Completion of treatment in a Phase III
study is a significant milestone for our lead drug candidate. We were encouraged by the positive interim data analysis provided by the
Independent Data Monitoring Committee following treatment of the first 200 patients in this study. We are hopeful that Piclidenoson has
helped the treated patients and that it may provide safe, long term relief from the symptoms of psoriasis," stated Can-Fite CEO
Otezla reported generating $2.2 billion in
sales in 2020. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson
has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential
upcoming milestone payments and double-digit royalties upon regulatory approval.
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, is currently
in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver cancer, and a Phase IIb 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. 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.
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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
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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 impact
of the COVID-19 pandemic; 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.