Madrid, 7th September, 2009.- Cx601 from CELLERIX (a product-focused biopharmaceutical company which develops innovative medicines based on cell therapy) has been designated as an Orphan Medicinal Product by the EMEA (European Medicines Agency) for the treatment of anal fistula. CELLERIX also has another two products under development with the designation of orphan status: Ontaril^® (Cx401), also for the treatment of anal fistula, currently in Phase III, and Cx501 for skin regeneration (epidermolysis bullosa - EB), currently in Phase II.

Cx601 is part of a new generation of products based on expanded stem cells obtained from adipose tissue (eASCs) taken from donors (allogenic origin). Cx601 is currently in Phase II trials and it is being developed for the local treatment of complex perianal fistulas in Crohn 's patients.

“The orphan status designation for our product Cx601 is a great milestone for our company. It also implies an important step in the investigation and development of our innovative allogenic platform, which will allow us to fulfill current clear medical needs in the near term” commented Eduardo Bravo, CELLERIX CEO.

CELLERIX recently started a multicenter trial for Cx601 with 24 patients with complex perianal fistulas with Crohn 's disease and it is expected that it will conclude by the end of 2009. The results are expected to be ready by the second semester of 2010. This trial in complex perianal fistulas is a first indication and CELLERIX expects to advance towards other pathologies in the near future, where local treatment with expanded stem cells obtained from the adipose tissue of allogenic origin could prove effective.

Orphan Medicinal Products (orphan status)

The products under this designation are those whose objective is to diagnose, prevent or treat life threatening or very serious rare diseases affecting not more than 5 people out of 10.000 in the EU, and which address a clear unmet need.

Notes to the editor

CELLERIX is a biopharmaceutical company developing innovative medicines based on cell therapy. The company has three products undergoing clinical trials: Ontaril^® (Cx401) for the treatment of perianal fistulas, currently in Phase III, Cx501 for skin regeneration, currently in Phase II and Cx601 for the treatment of perianal fistulas, in phase II.