Belgium-based biopharmaceutical firm TiGenix has marked the initiation of a Phase III clinical trial of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients with its first European investigator meeting.
The firm intends to hold similar investigator meetings in Europe (EU), Israel, the US and Canada from the fourth quarter of this year.
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Cx601 is a formulation of allogeneic expanded adipose-derived stem cells (eASCs), which are being developed for local administration at present.
The global, randomised, double-blind, placebo-controlled Phase III trial is currently being conducted to support a future regulatory filing for Cx601 in the US, and will assess the safety and efficacy of a single dose of Cx601 in patients who failed prior standard therapy.
The trial design is similar to the previous European Phase III ADMIRE-CD trial for Cx601, which was conducted in August 2015, with an identical primary endpoint of greater probability of obtaining combined remission.
TiGenix chief medical officer Dr Marie-Paule Richard said: "Investigator meetings are critical to the success of any clinical trial.
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By GlobalData“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."
In January this year, the US Food and Drug Administration (FDA) said that the firm can file a US Biologics License Application (BLA) for Cx601 based on the results from the global Phase III trial with a broader patient population at week 24, instead of week 52.
The adjustments to the trial are expected to accelerate the enrolment, result in shorter timelines, earlier filing and possible early approval of the drug in the country.
