13 June 2017
TiGenix Launches Global Phase III Trial for Cx601
Leuven (BELGIUM) – June 13, 2017, 07:00h CEST – 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. The 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. 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.
“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 Panés. “We are eager to continue building on the evidence gained from the ADMIRE-CD trial and, ultimately, to offer patients a durable cure for their complex perianal fistulas, which remain a severe and debilitating complication of Crohn’s disease.”