TiGenix’s Cx601 was able to resolve a painful Crohn’s disease condition known as complex perianal fistulas for a year, according to a Phase 3 trial.
Only a quarter of the patients whose condition was resolved within 24 weeks of the treatment had it recur by week 52, researchers said. That compared with 44.1 percent recurrence in a group treated with a placebo.
An anal fistula is a small channel that can develop between the end of the bowel and the skin near the anus. It can cause bleeding and discharge when defecating, and can be painful.
TiGenix will present the results of the ADMIRE-CD Phase 3 clinical trial (NCT01541579) at the Digestive Disease Week (DDW) annual meeting in Chicago, May 6-9. The presentation will be entitled “Cx601, Allogeneic Expanded Adipose-Derived Mesenchymal Stem Cells (eASC), For Complex Perianal Fistulas In Crohn’s Disease: Long-Term Results From A Phase III Randomized Controlled Trial.”
Professor Julian Panés, head of the Gastroenterology Department at the Hospital Clinic of Barcelona, will deliver the presentation. He is also president of the European Crohn’s and Colitis Organization.
Cx601 closed all external openings that had been draining at the beginning of the clinical trial, according to interim results. Researchers confirmed the absence of perianal fistulas after treatment with magnetic resonance imaging (MRI).
Seventy of the 105 patients treated with Cx601 stayed in the trial until the follow-up period ended at week 52.
The most common adverse events of the therapy were anal abscesses, or sores, and proctalgia, or pain in the rectum and anus area. Still, the frequency of the events was similar between the treatment and placebo groups.
“We are delighted that the positive 52-week results from the ADMIRE-CD Phase III trial demonstrating the long-term safety and efficacy of Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients will be presented at a dedicated lecture at the DDW,” Dr. Marie Paule Richard, chief medical officer of TiGenix, said in a press release. “The DDW is one of the most prestigious congresses in GI. We are honored that these data will be presented to the US medical community, a key milestone in the preparation for the launch of our global pivotal Phase III trial in the first half of 2017.”
TiGenix will host a meeting of gastrointestinal experts during the convention — from 5 to 6 p.m. on May 8 at the Westin Chicago River North. They will discuss what remains to be done in the treatment of complex perianal fistulas. The company will provide an overview on Cx601 at the gathering, including ways it can be used to manage the Crohn’s complication.
The meeting will be broadcast by webcast. It can be accessed at http://www.wsw.com/webcast/cc/tig.