title: Treatment of plaque-type psoriasis with oral CF101: data from an exploratory randomized phase 2 clinical trial.
abstract: OBJECTIVE
  CF101 demonstrated a marked anti-inflammatory effect in Phase 2 studies conducted in patients with rheumatoid arthritis and dry eye syndrome. The aim of this study was to evaluate the safety and efficacy of CF101 for the treatment of patients with moderate to severe plaque-type psoriasis.
  
  
  METHODS
  This was a phase 2, multicentre, randomized, double-blind, dose-ranging, placebo-controlled study. Seventy five patients with moderate to severe plaque-type psoriasis were enrolled, randomized and treated with CF101 (1, 2, or 4 mg) or placebo administered orally twice daily for 12 weeks. Safety and change from base line of Psoriasis Area and Severity Index (PASI) score and physician's global assessment (PGA) score over 12 weeks.
  
  
  RESULTS
  In the 2 mg CF101-treated group, a progressive improvement in the mean change from baseline in the PASI score vs. placebo throughout the study period was observed, with a statistically significant difference on weeks 8 and 12 (P = 0.047; P = 0.031, respectively). In this group, 35.3% of the patients achieved PASI ≥ 50 response, and 23.5% of the patients achieved a PGA score of 0 or 1. CF101 was safe and well tolerated.
  
  
  CONCLUSIONS
  CF101 was well tolerated and demonstrated clear evidence of efficacy in patients with moderate to severe plaque psoriasis.
authors.affiliation: Department of Dermatology, Rabin Medical Center, Tel Aviv University, Petah-Tikva, Israel.
authors.forename: M
authors.initials: M
authors.lastname: David
authors.forename: L
authors.initials: L
authors.lastname: Akerman
authors.forename: M
authors.initials: M
authors.lastname: Ziv
authors.forename: M
authors.initials: M
authors.lastname: Kadurina
authors.forename: D
authors.initials: D
authors.lastname: Gospodinov
authors.forename: F
authors.initials: F
authors.lastname: Pavlotsky
authors.forename: R
authors.initials: R
authors.lastname: Yankova
authors.forename: V
authors.initials: V
authors.lastname: Kouzeva
authors.forename: M
authors.initials: M
authors.lastname: Ramon
authors.forename: M H
authors.initials: MH
authors.lastname: Silverman
authors.forename: P
authors.initials: P
authors.lastname: Fishman
mesh_terms: D000241:Adenosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: C478920:CF101; D010919:Placebos; D000241:Adenosine