PETACH TIKVA, Israel, June 17, 2014 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today it has finalized enrollment in its Phase II/III trial of CF101 for the treatment of psoriasis with over 300 patients through 17 clinical centers in the U.S., Israel and Europe. Top line results from the trial are expected in the first quarter of 2015.
The psoriasis therapeutic market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018, according to Global Data. The market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects.
“Based on our studies to date, we believe that, if approved, CF101 would have the potential to offer an oral, safe and well-tolerated treatment alternative for people living with psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman. “Now that we have completed patient enrollment, we hope that the upcoming conclusion of this Phase II/III trial will yield additional data which may prove the efficacy of CF101 in the treatment of psoriasis.”
About the Trial
The Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in 300 patients with moderate-to-severe plaque psoriasis. 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 Physicians’ Global Assessment (PGA) score as well as various safety parameters.
Interim safety and efficacy results were released from the first 103 patients who completed 24 weeks of treatment in the trial. The positive clinical effects of CF101 at the 2 mg dose relative to placebo were observed through PASI and PGA scores, with the responses accumulating steadily over the 24-week treatment period. To allow the trial to meet its full objectives, the study protocol has been amended to enroll patients for the 2 mg dose and placebo administration for an extended study period of 32 weeks.
