ISSN: 1745-7580
						Tatiana Reitblat 
	
					    												
Israel						                            
                            
						
 Research Article
												Therapeutic Effect of Oral CF101 in Patients with Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Phase II Study 						
Author(s): Rumen M Stoilov, Rodina N Licheva, Mariyana K Mihaylova, Tatiana Reitblat, Emil A Dimitrov, Krasimira M Shimbova, Girish Bhatia, Ameet Pispati, Alexandra Gurman- Balbir, BR Bagaria, Boytcho Aleksandrov Oparanov, Sari Fishman, Zivit Harpaz, Motti Farbstein, Shira Cohen, David Bristol, Michael H Silverman and Pnina Fishman
Rumen M Stoilov, Rodina N Licheva, Mariyana K Mihaylova, Tatiana Reitblat, Emil A Dimitrov, Krasimira M Shimbova, Girish Bhatia, Ameet Pispati, Alexandra Gurman- Balbir, BR Bagaria, Boytcho Aleksandrov Oparanov, Sari Fishman, Zivit Harpaz, Motti Farbstein, Shira Cohen, David Bristol, Michael H Silverman and Pnina Fishman
             
						
												
				 Background: CF101, an orally bioavailable A3 adenosine receptor (A3AR) agonist, demonstrated very good safety and anti-inflammatory effect in Phase II clinical studies in patients with rheumatoid arthritis (RA) and psoriasis. A3AR expression level in peripheral blood mononuclear cells has been defined as a biological predictive marker, based on a significant correlation found in a former RA Phase II study between its over expression at baseline and positive patients’ response to CF101 treatment.
Methods: 79 patients were enrolled to a phase II, multicenter, randomized, double-blind, Placebo controlled, parallel-group study designed to assess the efficacy and safety of CF101 1mg vs. placebo, administered orally twice daily to patients with active RA for 12 weeks. Primary efficacy endpoint was ACR20 response at week 12 and secondary efficacy included ACR 50/70. Patients wer.. View More»
				  
												DOI:
												 10.4172/1745-7580.1000087