Prior to Phase III Psoriasis Data Release Can Fite Reports that Piclidenoson Destroys Pathological Skin Cells in vitro
13 Enero 2022 - 6:00AM
Business Wire
Piclidenoson has been out-licensed for the
indication of psoriasis in certain major markets
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 that pre-clinical studies with skin
cells, modeling psoriasis in humans, show that Piclidenoson, the
Company’s drug candidate for the treatment of psoriasis, destroys
pathological skin cells. The Company’s scientists reported that in
a cell culture of human HaCaT cells, incubated with Piclidenoson,
cell apoptosis was induced with an increase in the caspase protein,
known to mediate apoptotic responses.
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
studies.
The Company expects to announce topline results during Q1 2022
from its randomized, double blind, active and placebo-controlled
study currently 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 target.
“The data shown in our lab experiments are important and support
the mechanism of action of Piclidenoson and supply additional
support for the drug effect. We are encouraged by the positive
interim analysis data reported last year based on 200 patients’
data and hope that it will be reproducible and that psoriasis
patients will benefit from safety and long term relief from the
symptoms of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.
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.
Forward-Looking Statements
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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
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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
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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
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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.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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