Date: 2015-03-30
Type of information: Results
phase: 2-3
Announcement: results
Company: Can-Fite BioPharma (Israel)
Product: CF101 (IB-MECA (methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-b-D-ribofuronamide)
Action
mechanism: CF101 is an A3 adenosine receptor agonist. CF101 mechanism of action includes modulation of key signaling proteins, such as PI3K, PKA, PKB/Akt, IKK and NF-?B, resulting in inhibition of inflammatory cytokine production.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: USA, Israel, Bulgaria, Romania
Trial
details: 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. (NCT01265667)
Latest
news: * On March 30, 2015, Can-Fite BioPharma, a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced that its Phase II/III psoriasis trial for the Company's drug candidate CF101 did not achieve its primary endpoint. This Phase II/III double-blind, placebo-controlled study was designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis. Can-Fite enrolled a total of 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study segment was comprised of three arms with 103 patients who received either 1 mg of CF101; 2 mg of CF101; or placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks and continued receiving treatment until week 24. Following a positive interim analysis, Can-Fite continued to enroll patients to the second segment of the study. The second study segment was comprised of two arms with 223 patients receiving either 2 mg of CF101 or placebo. All patients receiving placebo were switched to 2 mg of CF101 after 16 weeks and continued receiving treatment until week 32. The primary efficacy endpoint was a statistically significant improvement in the Psoriasis Area Sensitivity Index (PASI) score relative to placebo treatment, and the secondary endpoints were, among others, the Physicians' Global Assessment (PGA) score as well as various safety parameters. The proportion of patients treated with CF101 who achieved at least a 75% improvement from baseline in disease severity at week 12, as measured by PASI 75 was 8.5% vs. 6.9% in the placebo group. With respect to PGA, 6.4% of patients treated with CF101 achieved clear or almost clear skin at week 12 compared to 3.4% of the placebo patients. CF101 was found to be safe and well tolerated. * On February 4, 2015, Can-Fite BioPharma announced 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. * On August 6, 2014, Can-Fite BioPharma announced new data from a retrospective analysis of its autoimmune disease advanced trials that shows high efficacy of its orally bioavailable drug CF101. The retrospective study, conducted by a third party statistician group, analyzed the correlation between response to CF101 and patients' body mass index (BMI) in the Phase II/III Psoriasis interim results as well as the recently completed Phase II Rheumatoid Arthritis trial. The data shows a significant increase in the response to CF101 in patients with a BMI of over 25 in both studies. These findings corroborate the efficacy seen with other FDA approved drugs such as cyclosporine A which was more effective in patients with high BMI. The company believes these findings will enable it to optimize the design of its forthcoming Phase III studies. Can-Fite's Phase II/III Psoriasis trial is ongoing with data expected to be released in the first quarter of 2015. * On June 17, 2014, Can-Fite BioPharma announced 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. 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.
