PETACH TIKVA, Israel,
Feb. 8, 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 the Company is
ready to commence patient enrollment in the second quarter of 2017
in its global Phase III trial of its lead drug candidate
Piclidenoson as a first line treatment for rheumatoid arthritis.
The trial, titled ACRobat, will enroll approximately 500 patients
in Europe, Canada and Israel.
The estimated cost of the entire Phase III study is
approximately $5 million. This
includes the cost of the global clinical research organizations
that have been engaged to help conduct ACRobat. The required supply
of Piclidenoson has already been manufactured and paid.
Piclidenoson is being developed as a first line therapy and
replacement for the current standard of care, Methotrexate (MTX),
the most widely used drug for rheumatoid arthritis. The primary
endpoint of ACRobat, a randomized, double-blind, active and
placebo-controlled study, 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.
"We are eager to commence our Phase III rheumatoid arthritis
trial in the second quarter. We believe Piclidenoson can offer a
superior alternative to MTX, which is used at some point by
approximately 90% of rheumatoid arthritis patients. MTX is an
oncology drug known to induce severe adverse events. Piclidenoson's
well established and excellent safety profile, as demonstrated in
previous clinical studies in more than 1,000 patients, combined
with a potential for efficacy equal to or better than MTX,
positions Piclidenoson as a potential future first line therapy of
choice for doctors treating rheumatoid arthritis," stated Can-Fite
CEO Dr. Pnina Fishman.
Although approximately 90% of rheumatoid arthritis patients
receive MTX at some point in their disease according to the
Arthritis Foundation of America, 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.
Rheumatoid arthritis is a treatment market forecast to reach
$38.5 billion by 2017.
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 Phase III trials in 2017 for two indications,
rheumatoid arthritis and psoriasis. 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 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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