BioCentury
ARTICLE | Clinical News

TiGenix starts Phase III ADMIRE-CD II trial of Cx601

July 5, 2017 7:45 PM UTC

TiGenix N.V. (Euronext:TIG; NASDAQ:TIG) began the Phase III ADMIRE-CD II trial of Cx601 to treat complex perianal fistulas in patients with Crohn’s disease (CD). The double-blind, placebo-controlled, international trial is evaluating the combined remission of perianal fistulizing CD defined as the closure of treated external openings and absence of collections of the treated perianal fistulas.

FDA agreed to a shortened trial design that would allow the company to submit a BLA for the product earlier than originally planned. The amended protocol will evaluate safety and efficacy data at week 24, rather than at week 52 as stipulated in the original 2015 SPA (see BioCentury, March 13)...