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Patients enrolled into VIPES phase II clinical study have completed 6 months
VIPES' Data and Safety Monitoring Board meeting met in February 2014 and concluded that the study presented no safety concerns and recommended to proceed per protocol
VIPES drop-out rate below expectations, at 4% as of today
DBV anticipates reporting VIPES 12-month topline data in October 2014
DBV to hold "R&D Day" for the investment community in New York City on May 21st
BAGNEUX, France, March 17, 2014 (GLOBE NEWSWIRE) -- DBV Technologies (Euronext: DBV - ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergy, announced today its full year 2013 results, approved by the Board of Directors on March 14, 2013. DBV also provided an update on 'VIPES' phase IIb clinical study of Viaskin® Peanut and precised the date on which it will hold an R&D day for the investment community.
Peanut Allergy phase IIb study ('VIPES') update
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 third Data and Safety Monitoring Board meeting held on February 24, 2014, the independent members reviewed the safety data of all the 221 subjects randomized and treated in the VIPES study. 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 in October 2014. Furthermore, as of today, VIPES' drop-out rate stands at 4%, far below the 15% drop-out rate initially anticipated at the end of the study.
Viaskin® Peanut was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).