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TiGenix NV (Euronext Brussels: TIG) submits MAA to EMA

March 2, 2016 2:31pm

TiGenix NV submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Cx601 for the treatment of complex perianal fistulas in adult patients with Crohn's disease.

TiGenix has submitted a European MAA for its lead product Cx601, consisting of a suspension of allogeneic expanded adipose-derived stem cells (eASC), following the positive results from the pivotal ADMIRE-CD Phase III study in Crohn's disease patients suffering from complex perianal fistulas.

A complex perianal fistula consists of abnormal tracts between the rectum and the skin surface near the anus, and is commonly associated with Crohn's disease.

It is a serious clinical condition leading to pain, discharge and that can cause severe incontinence. Complex perianal fistulas are associated with depression and may constitute a risk for anorectal carcinoma.

The Bottom Line: This submission represents an achievement for this serious and debilitating condition and brings TIG one step closer to making this therapy to EU patients in the second half of 2017.

This achievement follows the completion of the ADMIRE-CD trial in August, the recently granted license to manufacture Cx601 commercially in the EU and the agreement from the FDA through a Special Protocol Assessment (SPA) to conduct a P3 pivotal trial in the US.

The results of the ADMIRE-CD have also been accepted for oral presentation at the upcoming Annual Congress of European Crohn's and Colitis Organisation (ECCO) in Amsterdam on 17th and3/18/16. The acceptance of the abstract confirms the relevance of the results and positions Cx601 as a truly innovative treatment for complex perianal fistulas in Crohn's disease patients, a severe, debilitating and difficult to treat condition.

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. Cx601 is being developed for the treatment of complex perianal fistulas in Crohn's disease patients;

Crohn's disease is a chronic inflammatory disease of the intestine and patients can suffer from complex perianal fistulas for which there is currently no effective treatment;

Up to 120,000 adult Crohn's disease patients in Europe and the United States may eventually benefit from Cx601 in an indication for which there is no alternative satisfactory treatment.

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