Full Press Release Details
Completes the Design of the Rheumatoid Arthritis Phase III Study of Its Lead Drug Candidate CF101
estimated global market of Rheumatoid Arthritis is expected to reach $38B in 2017
TIKVA, Israel, December 30, 2014 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with
a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it completed
the design of the Rheumatoid Arthritis (RA) Phase III study of its lead drug candidate CF101. Dr. M. Silverman, Can Fite Medical
Director, and Dr. Lee Simon, a key opinion leader in the field of autoimmune inflammatory diseases, designed the Phase III clinical
III study will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that will investigate the
efficacy and safety of daily CF101 administered orally as a monotherapy for 12 weeks to patients with active RA. The study will
have three arms, a 2 mg CF101 dose, a 3mg CF101 dose and placebo, given orally twice daily in the form of tablets. Approximately
300 patients are expected to be enrolled in the study, where sample size for each treatment group will be approximately 100 patients
and will provide a statistical power of at least 90%. The study primary end point will be ACR 20 response at Week 12. The A3 adenosine
receptor biomarker will be evaluated prior to treatment and its correlation to patients' response to the drug will be analyzed
upon study conclusion.
III design is based on positive data received from the company's completed Phase IIb study in which CF101 was administered
as a monotherapy. The Phase IIb study was a 12-week multicenter, randomized, double-blind, placebo-controlled, parallel-group
study involving 79 patients with active RA. In the study, patients treated with 1mg CF101 met all primary efficacy endpoints with
statistically significant superiority over placebo in reducing signs and symptoms of RA as compared to the placebo.
CEO Pnina Fishman stated, "We are very pleased that the Phase III design is completed and based on the positive data of
the prior Phase II study we believe that increasing the drug dose will yield positive data and those patients with RA will be
able to benefit from our oral drug."
to independent business information provider visiongain, the global RA drug market is expected to generate revenues of $38.5bn
in 2017. Can-Fite's Phase II/III psoriasis trial is ongoing with data expected to be released in the first quarter of 2015.
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 and inflammatory diseases. The Company's
CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid
arthritis. Can-Fite's liver cancer drug CF102 is commencing Phase II trials and has been granted Orphan Drug Designation
by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon,
prostate, and melanoma. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies
to date. For more information please visit: www.can-fite.com
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