Full Press Release Details
Gears Up for ACRobat, its Phase III Trial of Piclidenoson in Rheumatoid Arthritis
TIKVA, Israel, February 8, 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 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.
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
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.
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.
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.
arthritis is a treatment market forecast to reach $38.5 billion by 2017.
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 (completed Phase II) and psoriasis (completed Phase II/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 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.
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