Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
July 27 2020 - 7:00AM
Business Wire
- 28-day study in hospitalized patients with moderate COVID-19
symptoms
- Piclidenoson is an anti-inflammatory drug with a
well-established safety profile
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 it has submitted an Investigational
New Drug (IND) application to U.S. Food and Drug Administration
(FDA) for a Phase II study of its lead drug candidate Piclidenoson
in the treatment of COVID-19. The IND application is based on
feedback and guidance from the FDA from prior pre-IND advice.
Piclidenoson has been dosed in over 1,000 patients in prior
trials as well as two ongoing Phase III studies for the treatment
of rheumatoid arthritis and psoriasis.
“With the unfortunate resurgence of COVID-19 infections
worldwide, the urgency of finding effective treatments for COVID-19
is more pressing now than ever. Working with the FDA through its
Coronavirus Treatment Acceleration Program (CTAP), we expect IND
activation soon to begin our Phase II trial,” stated Can-Fite CEO
Dr. Pnina Fishman.
The Phase II study titled, “Piclidenoson for Treatment of
COVID-19 – A Randomized, Double Blind, Placebo-Controlled Trial” is
a pilot trial in a population of hospitalized patients who will
receive Piclidenoson in addition to standard supportive care.
Eligible patients are those with “moderate” COVID-19 per U.S.
National Institutes of Health Coronavirus Disease 2019 (COVID-19)
Treatment Guidelines. Forty patients will be randomly assigned in a
1:1 ratio to the trial arms of Piclidenoson 2 mg twice daily or
placebo, and treated for up to 28 days. Efficacy will be assessed
through standard measures of clinical and respiratory status at Day
29, including the proportion of patients alive and free of
respiratory failure, as well as the proportion discharged home
without need for supplemental oxygen. Safety and pharmacokinetic
data will also be captured.
About Piclidenoson
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. Piclidenoson is currently under development for the
treatment of autoimmune inflammatory diseases and for the treatment
of COVID-19. It is being evaluated in multinational Phase III
studies as a first line treatment to replace methotrexate in the
treatment of rheumatoid arthritis, and as a treatment for
moderate-to-severe psoriasis.
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, inflammatory disease and COVID-19. The
Company's lead drug candidate, Piclidenoson, is currently in Phase
III trials for rheumatoid arthritis and 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 successfully achieved its primary endpoint in a Phase
II 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 recent outbreak of coronavirus;
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/20200727005133/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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