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DBV Technologies SA Provides Safety Update on Viaskin Peanut


Tuesday, 15 Oct 2013 02:01am EDT 

DBV Technologies SA (DBV) announced a clinical update on VIPES (Viaskin Peanut's Efficacy and Safety), a randomized, Phase IIb clinical trial of Viaskin Peanut in peanut allergic patients. DBV initiated VIPES in August 2012, enrolling 221 peanut-allergic patients including children, adolescents and adults. The trial is being conducted in Europe and North America by 22 different investigators. During the second Data and Safety Monitoring Board meeting held on September 9, 2013, the independent members reviewed the safety data of all the 221 subjects randomized and treated in the VIPES study. The safety data reviewed covered duration of treatments from 1 month up to 11 months. The DSMB concluded that the VIPES study presented no safety concerns and recommended DBV to proceed with the study as per protocol. DBV anticipates reporting VIPES 12-month topline data during the second half of 2014. Viaskin Peanut was granted Fast Track designation by the United States Food and Drug Administration (FDA).