TiGenix And Lonza Partner For Complex Perianal Fistulas In Crohn’s Disease Treatment

TiGenix And Lonza Partner For  Complex Perianal Fistulas In Crohn’s Disease Treatment
TiGenix, an advanced biotechnological company committed to developing and marketing new therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) for autoimmune and inflammatory diseases, together with Lonza, a leading and global company of biological and cell therapy manufacturing, have recently announced an agreement for Cx601, TiGenix's eASC product, to address Crohn's disease. The new agreement stipulates that Lonza will manufacture material for the Cx601 Phase 3 trial in the US, to be conducted at Lonza's cell therapy production facility in Walkersville, Maryland (US). Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) appropriated to treat complex perianal fistulas in patients suffering with Crohn's disease; the drug is currently in ongoing Phase 3 studies in Europe. Since TiGenix received positive feedback from the US Food and Drug Administration (FDA) at a recent meeting, the company is advancing Cx601's development for the US market. In order to be prepared to start a Phase 3 trial of Cx601 in the US and to supply the American market once the product is fully approved, TiGenix decided to partner with Lonza. In the following weeks, the technology transfer process between the two companies will begin. In late December 2014, TiGenix submitted a Special Protocol Assessment (SPA) requirement to the FDA. The understanding between the company and the FDA about the SPA assures that the trial is designed in tune with the FDA's requirements to have the drug approved. If this Phase 3 program in the US shows positive results, together with the European trial, TiGenix will be able to file a Biologics License Application (BLA) with the FDA. Eduardo Bravo, TiGenix's CEO, said in a pre
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