PETACH TIKVA, Israel,
May 16, 2017 /PRNewswire/
-- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, announced today it has filed a Clinical Trial Application
(CTA) with Health Canada for Piclidenoson. Can-Fite has a Canadian
distribution partner, Cipher Pharmaceuticals Inc. (Cipher) (TSX:
CPH).
Can-Fite intends to commence its Phase III Acrobat trial of
Piclidenoson in the treatment of rheumatoid arthritis in the second
quarter of 2017.
"We look forward to a positive response from Health Canada to
our CTA so that we may begin enrolling patients in Canada for our upcoming Phase III study.
Having recently received Institutional Review Board (IRB) approvals
in Israel for our rheumatoid
arthritis trial, we are ready to expand into clinical sites in
Canada and Europe," said Can-Fite CEO Dr. Pnina Fishman.
"New therapies are needed for people who face the tremendously
debilitating symptoms of rheumatoid arthritis," said Robert Tessarolo, President and CEO of Cipher
Pharmaceuticals. "We are looking forward to a positive outcome from
the Piclidenoson Phase III clinical program to help manage this
chronic disease."
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 and psoriasis, both set to commence Phase 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 autoimmune-inflammatory indications, oncology
and liver diseases as well as sexual dysfunction. The Company's
lead drug candidate, Piclidenoson, is headed into Phase III trials
for two indications, rheumatoid arthritis and psoriasis. Can-Fite's
liver cancer drug Namodenoson is in a Phase II trial for patients
with liver cancer and is slated to enter another Phase II for the
treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to 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 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.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a
robust and diversified portfolio of commercial and early to
late-stage products. Cipher acquires products that fulfill unmet
medical needs, manages the required clinical development and
regulatory approval process, and markets those products either
directly in Canada or indirectly
through partners in Canada, the
U.S., and South America. For more information, visit
www.cipherpharma.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 and Can-Fite's ability
to satisfy all the conditions to the closing of the proposed
offering, 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, including, but not limited to, the
factors summarized 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.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/can-fite-files-clinical-trial-application-in-canada-for-piclidenoson-ahead-of-upcoming-acrobat-rheumatoid-arthritis-phase-iii-study-300458161.html
SOURCE Can-Fite BioPharma Ltd.