- Q1 2022: Psoriasis Phase III Data & Commencement of
Enrollment in Phase IIb NASH
- H1 2022: Commencement of Enrollment in Phase III Liver
Cancer
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 issued a Letter to Shareholders from its Chief
Executive Officer, Dr. Pnina Fishman.
Dear Can-Fite Shareholders,
Beginning in the first quarter of 2022, we expect several
significant and value-driving events during the calendar year. We
are building upon the solid progress achieved in 2021 which
included the completion of a 400-patient Phase III psoriasis study,
the design, preparation, and clearance to commence our Phase III
liver cancer and Phase II NASH studies, as well as several
inventions and patents.
Topline Phase III Psoriasis Data Expected Q1 2022 – Our
Comfort™ Phase III study of Piclidenoson enrolled and treated
approximately 400 patients with moderate to severe plaque
psoriasis. In the first quarter, we expect to announce results from
the first 16 weeks of treatment, with the primary endpoint of the
study being a statistically significant improvement in achieving a
PASI score of 75 in Piclidenoson treated patients vs. placebo.
Later in 2022, we expect to announce the study’s secondary endpoint
at 32 weeks of treatment which is non-inferiority of Piclidenoson
vs. Otezla. The study has four treatment arms: Piclidenoson 2 mg,
Piclidenoson 3 mg, Otezla®, and placebo.
Should the topline results confirm Piclidenoson’s efficacy at 16
weeks as compared to placebo, we believe this would be a
significant value-driving event. Piclidenoson has already been
out-licensed to distribution partners in some European countries,
Canada, South Korea, and China through agreements that include
milestones payments, and we believe that positive results would
trigger high interest in Piclidenoson in other major healthcare
markets in which we are currently talking with potential
partners.
Following 32 weeks of treatment, if Piclidenoson proves
non-inferior to Otezla, we believe this would be a significant
event in the psoriasis treatment market, as Piclidenoson and Otezla
are both oral drugs in a market dominated by injection-based
biologics. We believe it is Otezla’s oral dosing advantage that has
led to the drug capturing robust market share and being acquired by
Amgen for $13 billion in 2019.
Phase IIb NASH Study Expected to Commence Patient Enrollment
in Q1 2022 - The study will enroll 140 patients with
biopsy-confirmed NASH with a primary endpoint to evaluate the
efficacy of Namodenoson as compared to placebo, as determined by a
histological endpoint. Patients will be randomly assigned in a 2:1
ratio to oral doses of Namodenoson 25 mg or placebo every 12 hours
for 36 weeks. There is currently no FDA approved treatment for
NASH, an urgent unmet need that is a leading cause of liver
transplants.
Patient Enrollment Expected to Commence in Pivotal Phase III
Liver Cancer Study H1 2022 – In December, we announced that a
prior Phase II liver cancer study patient who continues to be
treated with Namodenoson has survived five years and cleared all
cancer lesions. We see this as a very positive sign as we expect to
commence enrollment in the first quarter of 2022. Approximately 450
patients diagnosed with hepatocellular carcinoma (HCC) and
underlying Child Pugh B7 (CPB7) who have not responded to other
approved therapies will be enrolled through clinical sites
worldwide. Patients will be randomized to oral treatment with
either 25 mg Namodenoson or matching placebo given twice daily. The
primary efficacy endpoint of the trial is overall survival. An
interim analysis will be conducted by an Independent Data
Monitoring Committee after 50% of patients are enrolled.
While several approved therapies exist for liver cancer,
advanced patients often become unresponsive to treatment. With its
liver protective properties, Namodenoson helped CPB7 patients who
were unresponsive to approved treatments achieve a statistically
significant improvement in overall survival as compared to placebo
in our prior Phase II study. Namodenoson has been out-licensed to
three partners in the indications of liver cancer and NASH in
Eastern Europe, South Korea, and China.
We enter 2022 with a strong balance sheet, having raised $10
million in December in addition to the $13.3 million we reported at
the end of Q3 2021. While our advanced clinical trials addressing
multi-billion markets in psoriasis, liver cancer, and NASH are
expected to be our main drivers, we also expect continued
development and potential value events from our out-licensing of
Piclidenoson to treat osteoarthritis in the veterinary market, as
well as development of CF602 in the treatment of erectile
dysfunction, and our preclinical work with cannabinoids.
We wish all of you a healthy and happy 2022, and we look forward
to sharing significant news during the year.
Sincerely,
Pnina Fishman, Ph.D.
Chief Executive Officer
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
This 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220105005462/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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