Takeda, TiGenix report positive data from phase III Admire-CD clinical trial: 3 key notes

Japan-based Takeda and Leuven, Belgium-based TiGenix NB reported positive data from Admire-CD's Cx601 phase III clinical trial.

Researchers conducted a randomized, double-blind, controlled phase III trial to test the efficacy and safety of Cx601, stem cells designed to treat complex perianal fistulas in Crohn's Disease patients.

Patients received either a single dose of Cx601 cells or a control.

Here's what they found.

1. Fifty-six percent of the Cx601 group versus 38.6 percent of the control group achieved clinical and radiological combined remission. Fifty-nine percent and 41 percent achieved clinical remission.

2. Of the patients who showed remission at week 24, a greater number in the Cx601 group reported no relapse than the control group.

3. Adverse events were similar between the two groups.

CMO at TiGenix Marie Paule Richard, MD, concluded, "These data highlight that the efficacy and safety of a single administration of Cx601 were maintained during one year of follow up. 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 most 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."

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