tKanVriezenEnDooien schreef op 22 november 2017 20:11:
Tigenix staat vlak voor goedkeuring van Cx601 / Alofisel in Europa en is nu ook bezig met recruiteren voor de Global fase 3 trial ter ondersteuning van de aanvraag in de VS.
Zie
clinicaltrials.gov/ct2/show/NCT032790...The global pivotal Phase III trial is a randomized, double-blind, placebo-controlled study designed to
confirm the efficacy and safety of a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients. The trial design is similar to the European Phase III ADMIRE-CD trial for Cx601 with an identical primary endpoint. In January 2017, the U.S. Food and Drug Administration (FDA) agreed to the design of the protocol for the global Phase III trial, and confirmed that a future U.S Biologics License Application (BLA) could be filed based on the study results at week 24, instead of week 52, from a broader patient population than the initial Special Protocol Assessment (SPA) formally endorsed in August 2015. With these adjustments, the trial should benefit from an expedited recruitment process, leading to shorter timelines, an earlier filing, and the possibility of an earlier approval in the U.S.