|Can Fite Biopharma Ltd (ADR) NYSEMKT CANF) Slumps On Drug Trial Failure|
|By Josh Gee|
|Tuesday, 31 March 2015 14:31|
Biotechnology Company Can Fite Biopharma Ltd (ADR) (NYSEMKT CANF) that is involved in a pipeline of proprietary small molecule drugs addressing cancer and inflammatory diseases has confirmed that the Phase II/III psoriasis trial for the firm’s drug candidate CF101 could not get the desired first endpoint.
This Phase II/III double-blind and placebo-controlled study was made to look at the effectiveness of CF101 in patients having moderate-to-severe plaque psoriasis.
All in all, the firm has confirmed 326 patients in 17 clinical centers in Europe, U.S and Israel. In the first study segment, there were three arms having 103 patients and all patients who got placebo were moved to either 1 mg or 2 mg of CF101 post 12 weeks and the treatment was there till week 24.
The company continued second study for patients after a positive interim analysis. On the other hand, the second study was of two arms for 223 patients and the ones who received placebo were changed to 2 mg of CF101 after 16 weeks and they got treatment till 32nd week.
The first efficacy endpoint was significant improvement in Psoriasis Area Sensitivity Index (PASI) score whereas the second one was Physicians' Global Assessment (PGA) score.
The number of patients getting CF101 who got 75% improvement by week 12 vis-a-vis PASI 75 was 8.5% vs. 6.9% in the placebo group. On the other hand, 6.4% of patients treated with CF101 got clear or almost clear skin at week 12 compared to 3.4% of the placebo patients.
Can-Fite CEO Dr. Pnina Fishman, stated that the firm is unhappy about the trial not meeting the primary endpoint as the PASI 75 and PGA didn’t get any real effect vis-a-vis placebo.
He added that the company has not finished analysis of secondary endpoint as well as sub-group analysis and plans to finish it in the future as the firm would carry on with the R&D.
Shares of the company slumped 45%.