Cf101 In Psoriasis Can-fite Originally Initiated A Phase 2/3 Clinical Trial Of Cf101 In Patients With Moderate To Severe Psoriasis In 2011 ( 16 ).
Based upon the Phase 1 studies, 4 mg total was selected as the highest dose for Phase 2 studies. CF101 in Psoriasis Can-Fite originally initiated a Phase 2/3 clinical trial of CF101 in patients with moderate to severe psoriasis in 2011 ( 16 ). The study enrolled 103 patients into one of three arms: 1 mg of CF101; 2 mg of CF101; or placebo. After 12 weeks of treatment, those in the placebo arm were randomized to receive either 1 or 2 mg of CF101 and the study continued for an additional 24 weeks. View gallery . An interim analysis was performed after 24 weeks of treatment, with the results showing a clear difference between patients in the 2 mg cohort and those receiving placebo. Importantly, there was also a marked improvement in patients who were randomized to the 2 mg cohort following the first 12 weeks on placebo in both PGA and PASI75, as shown in the following figure. View gallery . However, on March 30, 2015 Can-Fite announced topline results from the Phase 2/3 study showing that treatment with CF101 did not achieve the study’s primary endpoint, which was evaluation of PASI75 after 12 weeks of treatment ( 17 ). The proportion of patients treated with CF101 who achieved PASI75 was 8.5% compared to 6.9% in the placebo group.
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