OREANDA-NEWS. TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, is proud to present the week 24 positive results from its Phase III ADMIRE-CD pivotal study of Cx601 at the 2016 Digestive Disease Week (DDW) in San Diego, California (USA).

The ADMIRE-CD Phase III 24-week positive results will be presented by Professor Julian Pan?s, Head of the Gastroenterology Department, at the Hospital Clinic of Barcelona and Chairman of the TiGenix ADMIRE-CD Scientific Advisory Board in Europe, at the DDW session dedicated to Controlled Clinical Trials in Inflammatory Bowel Diseases on May 24, 2016 at 8:00am PDT. The DDW is the largest congress with international attendees organized in the US for this therapeutic field of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

In this double-blind, placebo controlled, randomized Phase III study, Cx601 met the primary endpoint of combined remission of complex perianal fistulas at week 24. As recently reported, Cx601 continued to show a sustained effect at week 52, while confirming the favorable safety and tolerability profile of the treatment. Combined remission is defined as the clinical assessment of the closure of all treated external openings draining at baseline combined with the absence of collection >2 of the treated perianal fistulas confirmed by central blinded MRI, and it is a more stringent definition of remission than the one commonly used in clinical trials on perianal fistulizing disease.

"The sustained effect of Cx601 after single injection is remarkable, particularly considering that a majority of patients treated were refractory to available therapies," said Dr. Juli?n Pan?s. "Cx601 has shown to provide a durable, effective and safe therapeutic alternative to address this serious clinical condition," he continued.

"Having been selected to present at DDW for an oral presentation, speaks of the quality of the ADMIRE-CD study," remarked Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. "We are honored to present our Phase III results to the US medical community at such a prestigious congress, and are confident this will raise the awareness of Cx601, especially as we prepare to initiate our pivotal Phase III trial for registration in the United States," she said.

"Following the FDAs agreement on the new Phase III design and planned analysis, Cx601 benefits from a clearly defined development and regulatory path for approval in the U.S.," commented Dr. William J. Sandborn, Professor of Medicine and Adjunct Professor of Surgery, Chief of Gastroenterology, and Director of the UCSD Inflammatory Bowel Disease Center, University of California San Diego and UC San Diego Health System, San Diego. Dr. Sandborn; who is also the Chairman of TiGenix's US Scientific Advisory Board, affirmed, "Cx601 has proven to be a novel approach to treat complex perianal fistulas, for which there is still no cure. In the US alone, 30,000 patients are waiting for an effective treatment for this debilitating disease."

This is the first ever positive Phase III trial with an allogeneic stem cell product, which confirms TiGenix's leadership position in the field of cell therapy. TiGenix submitted a Marketing Authorization Application for Cx601 in first quarter of 2016 to the European Medicines Agency, and expects to begin marketing in European markets in the second half of 2017.