TiGenix submitted the required documentation for a Special Protocol Assessment of its pivotal Phase III trial design for Cx601 to the U.S. Food and Drug Administration.
Cx601 is designed for use in the treatment of complex perianal fistulas in patients with Crohn's disease. The randomized, double-blind, placebo-controlled Phase III trial in the United States aims to evaluate the safety and efficacy of Cx601. The trial will enroll 180 patients and its primary endpoint will be the remission of fistulous disease. The study design is similar to the ongoing Phase III trial in Europe.
FDA approval of the SPA ensures that the trial design is aligned with the FDA's requirements for the future Cx601 approval.
"This is another important milestone, achieved according to plan, to prepare Cx601 for approval in the United States, the largest healthcare market in the world," said María Pascual, vice president of regulatory affairs and corporate quality at TiGenix. "The product's novel mechanism of action in treating perianal fistulas, and its advanced stage of clinical development in Europe, enables Cx601 to move directly into Phase III in the U.S., significantly shortening timelines, and the financial burden, of bringing the product to Crohn's disease patients in the U.S."
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