Israel’s Can-Fite BioPharma Ltd., a biotechnology company which develops proprietary small molecule drugs for treating cancer and inflammatory diseases, has completed the Design of the Rheumatoid Arthritis Phase III Study of Its Lead Drug Candidate CF101.
The company said that the Phase 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%. T
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The study’s 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.
The Phase 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.
Can-Fite 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.”
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 study.
The company stated that according to independent business information provider visiongain, the global RA drug market is expected to generate revenues of $38.5 billion in 2017. Can-Fite’s Phase II/III psoriasis trial is ongoing with data expected to be released in the first quarter of 2015.