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 all patients enrolled in its Phase II/III psoriasis trial for the Company’s drug candidate CF101 have completed the study’s 32 week treatment protocol. The trial has been completed and the final data is ready for analysis. The Company plans to publish top line results by the end of March 2015. Interim results from this Phase II/III trial and final results from the prior Phase II trial for CF101 in psoriasis were both positive.
“Following a thorough analysis of the data over the coming weeks, we look forward to announcing top line results on the efficacy and safety of CF101 in the treatment of moderate-to-severe plaque psoriasis. If these results are in line with the previously published favorable interim data, then we believe CF101 could offer a much-needed treatment alternative to patients living with psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.
The psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. According to Global Data, the psoriasis treatment market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018.
This Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis. Can-Fite enrolled 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study cohort was comprised of three arms with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The primary efficacy endpoints are a statistically significant improvement in standard measures used by dermatologists to assess psoriasis including the Psoriasis Area Sensitivity Index (PASI) score and the secondary end points among others are the Physicians’ Global Assessment (PGA) score as well as various safety parameters.
Can-Fite BioPharma Ltd.