Results and outcome of the study demonstrate very good safety and efficacy profiles

· Cx601 is a cell therapy for the treatment of complex perianal fistulas in Crohn´s patients.

· It is part of a new generation of products based on adult donor derived (allogeneic) expanded stem cells obtained from adipose tissue (eASCs).

· These results are extremely important and add value to CELLERIX as they represent a step forward in the development of therapies for autoimmune indications.

Madrid, 15 February, 2011.- CELLERIX, a product-focused biopharmaceutical company developing innovative medicines based on cell therapy, has disclosed the results of a Phase IIa clinical trial of its stem cell therapy Cx601 demonstrating very good safety and efficacy profiles.

Cx601 is part of a new generation of products based on adult donor derived (allogeneic) expanded stem cells obtained from adipose tissue (eASCs) which is being developed for the local treatment of complex perianal fistulas in Crohn´s patients.

The primary end-point of the Phase IIa trial was a safety evaluation, with efficacy-related data being a secondary objective. The trial was conducted in six Spanish hospitals, with 22 evaluated patients out of the recruited 24 patients completing the trial. eASCs (at a dose of 20 million cells) were implanted into the wall of a single fistula tract and a second dose (40 million cells) was implanted if closure of the tract was not observed at 12 weeks. A final evaluation was made after 24 weeks of follow-up.

The results of the trial provide an excellent demonstration of the safety profile of the product as only 5 patients experienced adverse events considered to be potentially eASC related. Of these patients only 2 were considered ”severe” and subsequently withdrawn from the study, however being probably more related to the disease itself than to study treatment.

The trial also provided promising data on the efficacy of the Cx601 therapy, as it was confirmed that treated tracts have a better outcome than non-treated ones. This was established both in terms of closure and reduction of draining fistulas. More than half of patients experienced closure of the external fistula orifice, many of them additionally showing re-epithelization of the opening. In most patients at least one previously draining fistula ceased suppuration.

Also, and extremely importantly, immunogenicity tests of blood samples of recruited patients analyzed by CELLERIX confirmed the low immunogenicity of allogenic expanded stem cells obtained from adipose tissue, demonstrating the viability of the allogeneic platform.

José Luis Bravo, CELLERIX’s VP Global Medical - R&D commented “the results obtained with Cx601 provide hope to patients suffering this disease as they presently do not count with a safe and really efficient treatment”

Eduardo Bravo, CELLERIX’s CEO has said “during the last year we have make a great effort to focus Cellerix’s activity in our allogeneic platform. These results add to the progresses made with other programs and demonstrate that the company is moving towards the right direction”

Complex perianal fistulas is a first indication for CELLERIX’s eASC platform and it is expected to advance in the near future in other autoimmune pathologies where treatment with eASC therapy could be effective.

Cx601 has been granted orphan status by the European Medicines Agency (EMA), for the treatment of perianal fistula.

Notes to the editor:

CELLERIX is a biopharmaceutical company developing innovative medicines based on cell therapy. It leads the development of a new generation of medicines based on expanded adult stem cells of allogeneic origin derived from the adipose tissue (eASCs).

CELLERIX’s focus is on inflammatory and autoimmune diseases, areas with high unmet need. Its allogeneic platform includes the Cx601 product –designated orphan status by the EMA- for the treatment of complex perianal fistulas in Crohn’s patients.