Can-Fite Successfully Completes Human Cardiodynamic Safety Trial for Piclidenoson
August 07 2017 - 7:00AM
Business Wire
Strong safety results clear Piclidenoson to
commence Phase III efficacy trials in the treatment of Rheumatoid
Arthritis and Psoriasis
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a
biotechnology company with a pipeline of proprietary small molecule
drugs that address inflammatory and cancer diseases, today
announced it has successfully concluded a cardiodynamic trial for
its lead drug candidate Piclidenoson (CF101). The trial is a
regulatory safety requirement of both the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) prior
to the initiation of Phase III studies. Based on the favorable
safety data from this cardiodynamic trial, Can-Fite is now cleared
to initiate two global Phase III studies for Piclidenoson: the
ACRobat trial in rheumatoid arthritis; and the Comfort trial in
psoriasis.
The cardiodynamic trial was a placebo-controlled crossover study
using precise methodology to determine the effect of Piclidenoson
on electrocardiograms of healthy volunteers. Such a study is
required by U.S. and European regulatory authorities before, or in
parallel with, Phase III to establish cardiac safety in humans
prior to registration for marketing approval. The primary objective
of the trial was to assess whether Piclidenoson causes a delay in
cardiac repolarization, as manifested by prolongation of the QT
interval of the electrocardiogram. A drug-induced delay in cardiac
repolarization creates an electrophysiological environment that can
lead to the development of ventricular cardiac arrhythmias.
In this study, Piclidenoson doses were up to 3-fold higher than
the highest dose expected to be used in the Company’s
registration-directed clinical trials. In yet another indication
that Piclidenoson has a favorable human safety profile, this
cardiodynamic trial showed that the Company’s highest projected
Piclidenoson dose had no clinically significant adverse
electrocardiographic effects, thereby enabling progression into
definitive Phase III trials.
“Data from this standard safety study required by the FDA and
EMA clearly demonstrated and reinforced the safety profile of
Piclidenoson. Our lead drug candidate has already been shown to be
safe and well tolerated in over 1,000 patients to date,” stated
Can-Fite Medical Director Dr. Silverman. “We look forward to
commencing patient recruitment and dosing for our Phase III trials
of Piclidenoson in rheumatoid arthritis and psoriasis.“
Rheumatoid arthritis is a treatment market forecast to reach
$38.5 billion by 2017. The psoriasis market is forecast to be $8.9
billion in 2018 and Otezla® sales are estimated to be $2.35 billion
by 2020.
About Piclidenoson (CF101)
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 including rheumatoid
arthritis (completed Phase II) and psoriasis (completed Phase
II/III).
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: 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
scheduled to enter a Phase III trial for rheumatoid arthritis in
2017 and a Phase III trial for psoriasis in early 2018. The
rheumatoid arthritis Phase III protocol has recently been agreed
with the European Medicines Agency. Can-Fite's liver cancer drug
Namodenoson is in Phase II trials for patients with liver cancer
and is slated to enter Phase II 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 hepatocellular carcinoma 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 in
preclinical studies and is being prepared for an IND submission to
the FDA and a Phase I trial. These drugs have an excellent safety
profile with experience in over 1,000 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: 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 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; estimates of our expenses,
future revenues, capital requirements and our needs for additional
financing; 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: http://www.businesswire.com/news/home/20170807005253/en/
Can-Fite BioPharmaMotti Farbstein,
+972-3-9241114info@canfite.com
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