PETACH TIKVA, Israel,
April 25, 2017 /PRNewswire/ --
- Barzilai Medical Center in Israel ready to enroll patients
- IRB approvals in European and Canadian medical centers
expected to follow
- Can-Fite to conduct Investigator Meeting in Europe with approximately 100 doctors from
participating clinical sites
- Piclidenoson being evaluated as first line therapy and
replacement for current standard of care Methotrexate
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 that Barzilai Medical Center's
Institutional Review Board (IRB) has approved the Phase III ACRobat
trial protocol and patient enrollment for the study at the 627-bed
hospital in Ashkelon, Israel. This
marks the first of several expected IRB approvals in medical
centers in Israel, Europe and Canada.
Piclidenoson is being developed as a first line therapy for
rheumatoid arthritis and replacement for the current standard of
care, Methotrexate (MTX). MTX is the most widely used drug for
rheumatoid arthritis, with approximately 90% of rheumatoid
arthritis patients receiving MTX at some point in their disease,
according to the Arthritis Foundation of America.
However, 40-50% of patients stop taking MTX after five years,
primarily due to the presence of serious side-effects, as indicated
in some published studies. Other studies show that between 10% and
30% of patients are intolerant of MTX, creating a significant need
in the market for a new, safe and effective treatment option.
The primary endpoint of ACRobat is low disease activity after 12
weeks of treatment in patients dosed with Piclidenoson compared to
those dosed with MTX. Piclidenoson at 1 mg and 2 mg, or placebo,
will be administered twice daily, and MTX or placebo will be
administered once weekly. The total study duration will be 24 weeks
in order to provide more data on long term efficacy and safety.
This randomized, double-blind, active and placebo-controlled study
will enroll approximately 500 patients through clinical sites in
Israel, Europe and Canada. On May 24,
2017, Can-Fite plans to conduct an Investigator Meeting in
Europe. During the meeting,
approximately 100 doctors participating as clinical investigators
in the global study will partake in a series of educational
sessions regarding Piclidenoson and the ACRobat protocol.
"Piclidenoson has demonstrated its safety profile in over 1,000
patients and prior clinical data show its potential to be as
effective, or more effective, than MTX in treating rheumatoid
arthritis. Our ACRobat trial is powered to demonstrate
Piclidenoson's potential as a first line therapy and superior
alternative to MTX, which unfortunately can have severe side
effects for patients who need a long-term treatment solution,"
stated Can-Fite CEO Dr. Pnina
Fishman.
Rheumatoid arthritis is a treatment market forecast to reach
$34.6 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 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.
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
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SOURCE Can-Fite BioPharma Ltd.