Leuven (BELGIUM) - August 7, 2015 - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic stem cells, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase III registration trial of Cx601 in the U.S. for the treatment of complex perianal fistulas in Crohn’s disease patients.
“We are very pleased with the FDA`s agreement on our clinical design and planned analysis as it represents a clearly defined development and regulatory pathway for approval of Cx601 in the U.S.,” said Dr Maria Pascual, VP Regulatory Affairs & Corporate Quality of TiGenix. “Cx601 constitutes a novel mechanism of action to treat perianal fistulas, for which there is still no cure. In the U.S. alone, every year more than 50,000 new patients are waiting for an effective treatment for this debilitating disease.”
The agreed pivotal trial is a randomised, double-blind, parallel group, placebo-controlled and multicentre study in complex perianal fistulas in Crohn’s disease patients. The study will enroll approximately 224 patients to assess the efficacy and safety of Cx601 24 and 52 weeks after a single dose administration of the product. The SPA describes the primary endpoint as combined remission, defined as clinical assessment by week 24 of closure of all treated external openings draining at baseline despite gentle compression, and absence of collections > 2cm confirmed by MRI. This primary endpoint is in line with the one for the European Phase III trial, which results are expected later this quarter. The company expects to complete the process of manufacturing technology transfer to its U.S.-based CMO, Lonza, and thereafter will start its Phase III trial of Cx601 in the U.S. in the second half of 2016.
Help employers find you! Check out all the jobs and post your resume.
