Can-Fite is Filing Drug Safety Update Report Showing Positive Safety Results from Phase II & Phase III Studies of Namodenoson...
03 März 2020 - 1:00PM
Business Wire
Favorable safety profile is a substantial
benefit in the treatment of chronic diseases that require long-term
dosing
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biopharmaceutical company with a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, today announced it is submitting its annual Drug Safety
Update Reports (DSUR) for both Piclidenoson and Namodenoson to the
governing health regulatory agencies where its drug candidates are
currently treating patients. Submission of the DSUR is an annual
requirement for investigational-stage new drugs under development
in territories which subscribe to the International Council for
Harmonization guidelines, including the U.S. Food and Drug
Administration and the European Medicines Agency. The DSUR includes
updates on drug safety information such as adverse events,
suspected unexpected serious adverse reactions, and other
indicators of potential risk. Can-Fite’s reports being filed this
year extend the growing body of documentation showing both
Piclidenoson and Namodenoson have favorable safety profiles and
risk-benefit ratios in more than 1,500 patients.
Dr. Michael Silverman, M.D., Can-Fite’s Medical Director,
commented, “We welcome the opportunity to compile our cumulative
data on a regular basis, as afforded by the DSUR process. As in
years past, these snapshots of our safety data continue to confirm
that both of our A3AR drugs in development are well-tolerated. We
are pleased that there are no emerging safety concerns that could
put patients at risk or impede our efforts to develop new drugs to
meet unmet patient needs. These latest data are particularly
robust, as we have achieved over 50% enrollment in both of our
Phase III studies for Piclidenoson, as well as having completed two
Phase II trials for Namodenoson.”
Piclidenoson is currently in two Phase III studies, one for the
treatment of moderate-to-severe psoriasis to establish superiority
versus placebo and non-inferiority versus Otezla® with over 50% of
the planned 407 patients already enrolled; and another for the
treatment of moderate-to-severe rheumatoid arthritis in newly
diagnosed patients to establish non-inferiority to MTX, the
standard of care, with over 50% of the planned 500 patients
enrolled, and an interim analysis is planned. Namodenoson has
completed a 78-patient Phase II study in liver cancer, and Can-Fite
is currently preparing for a Phase III trial in this indication.
Namodenoson has also recently completed enrollment in a 60 patient
Phase II study in the treatment of NASH, with topline results
expected later this month.
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 sexual
dysfunction. The Company's lead drug candidate, Piclidenoson, is
currently in Phase III trials for rheumatoid arthritis and
psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently
completed a Phase II trial for hepatocellular carcinoma (HCC), the
most common form of liver cancer, and is 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 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/20200303005502/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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