Full Press Release Details
Phase III ACRobat Trial in Rheumatoid Arthritis Approved by Institutional Review Board
TIKVA, Israel, April 25, 2017 - 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.
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.
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.
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.
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.
arthritis is a treatment market forecast to reach $34.6 billion by 2020.
Piclidenoson (CF101)
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.
Can-Fite BioPharma Ltd.
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.
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