TiGenix NV (Euronext Brussels and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting the anti - inflammatory properties of allogeneic, or donor - derived, stem cells to develop novel therapies for serious medical conditions , today announces that it has hosted its first European investigator meeting , which formally launches the global pivotal phase III clinical trial for Cx601 for the treatment of complex perianal fistulas in patients with Crohn’s disease. Similar investigator meetings are planned to take place in Europe (EU) , Israel, the United States and Canada from the fourth quarter of 2017. Th e global trial is designed to support a future regulatory filing for Cx601 in the U.S .

The first investigator meeting , held on June 8 and June 9 in Rome, Italy, brought together more than 60 leading gastroenterologists, colorectal surgeons and study co-ordinators from 30 confirmed clinical trial sites across Belgium, Czech Republic, Italy, Poland and Spain. Presentations were given by national and regional study co-ordinators, including the principal EU/Israel gastroenterologist study co-ordinator, Professor Julián Panés, Head of the Inflammatory Bowel Disease Unit at the Hospital Clinic of Barcelona (Spain) and President of the European Crohn’s and Colitis Organization (ECCO) , and the EU/Israel surgeon study coordinator , Dr. Damián García Olmo, Chief of the Department of Surgery at Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (Spain).

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. F ood 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.

“Investigator meetings are critical to the success of any clinical trial. The attendance and support from leading experts in the GI field confirms the strong interest from the medical community in our global phase III trial and, ultimately, for Cx601 as a potential new treatment for patients , " said Dr. Marie - Paule Richard, Chief Medical Officer at TiGenix .

“ Following my participation as Principal Investigator for the European ADMIRE - CD trial, which successfully met its primary endpoint and safety and efficacy profile, I am excited to participate in this global trial as study coordinator for Europe and Israel , ” said Professor Julian Pané s . “ We are eager to continue building on the evidence gained from the ADMIRE - CD trial an d, ultimately , to offer patients a durable cure for their c omplex per ianal fistulas , which remain a severe and debilitating complication of Crohn’s disease . ”

Subscribe to Directory
Write an Article

Recent News

El diagnóstico genético neonatal mejor...

Un estudio con datos de los últimos 35 años, ind...

Más de 1.500 cambios epigenéticos en e...

Un equipo de investigadores de la Universidad Juli...

Tuneable reverse photochromes in the sol...

A new technique allows the design of solid materia...

Highlight

Eosinófilos. ¿Qué significa tener val...

by Labo'Life

​En nuestro post hablamos sobre este interesante tipo de célula del...

Un estudio de INCLIVA muestra el efecto ...

by INCLIVA

Han desarrollado un estudio para evaluar la correlación entre el teji...

Photos Stream