Takeda (TYO:4502) and TiGenix (EBR:TIG) today touted long-term data from its phase III Admire-CD trial evaluating its suspension of allogenic expanded adipose-derived stem cells, Cx601, in patients with Chron’s disease. The study showed that Cx601 maintained long-term remission of treatment refractory complex perianal fistulas over 52 weeks.
The randomized, phase III trial compared Cx601 to a placebo control, which researchers gave in combination with standard of care. A significantly greater proportion of patients in the stem cell therapy group met clinical and radiological combined remission compared to their counterparts in the control arm after 52 weeks. The rates and types of treatment related adverse events were similar in both groups, the companies reported.
“Perianal fistulizing Crohn’s disease is difficult to treat with currently available therapies and often leads to pain, swelling, infection and incontinence,” Dr. Asit Parikh, head of Takeda’s gastroenterology therapeutic area unit, said in prepared remarks. “Existing therapies are limited and associated with complications and a high failure rate. Cx601 may offer patients an alternative treatment option.”
“These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up,” TiGenix chief medical officer Dr. Marie Paule Richard added. “It is important to also note that the definition of combined remission used in the Admire-CD study, which includes both clinical and radiological assessment by MRI, is more stringent than the criteria commonly used in previous large scale, randomized clinical trials evaluating perianal fistulas in Crohn’s disease, based only on clinical assessment.”
The European Commission gave Cx601 orphan designation for the treatment of anal fistula in 2009 and TiGenix said it expects to apply for fast track designation from the FDA. The company also said it plans to initiate a global pivotal phase III trial for U.S. registration with Cx601 this year.
TiGenix inked a licensing agreement with Takeda in July last year, granting Takeda exclusive rights to commercialize Cx601 outside of the U.S.