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TxCell Receives Approval for a Phase I/II Clinical Trial in Rheumatoid Arthritis

4/4/2011 9:43:46 AM

Valbonne, France, April 4th, 2011 - TxCell SA, a biotechnology company developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical need, announces today the approval by AFSSAPS, the French regulatory agency, of its application to carry out a phase I/II clinical trial of its second product candidate, TX-RAD.

The study RATS1 (Rheumatoid arthritis And Tr1 Study) will evaluate the safety and efficacy of the administration of TX-RAD, a type 1 regulatory T cell based immunotherapy, in patients with moderate to severe rheumatoid arthritis, who failed current treatments.

The planned study is an open label, 12 weeks multicenter phase I/II clinical trial. It will assess the tolerability and explore the efficacy of three consecutive injections of TX-RAD at escalating doses in patients with rheumatoid arthritis refractory to standard treatments including biologics. The trial will be conducted in several clinical sites in France. The study will include clinical, quality of life and joint imaging assessments.

“Despite multiple treatment options for rheumatoid arthritis, the disease continues to represent a high unmet medical need, particularly for patients failing currently available therapies,” said Miguel Forte, chief medical officer of TxCell. “The pre-clinical data in arthritis and the clinical results of our cell-based immunotherapy obtained in Crohn’s disease makes us believe that TX-RAD can represent an innovative and promising new treatment modality for patients with rheumatoid arthritis.”

“The go-ahead for TxCell’s second product candidate for another major chronic inflammatory disease further validates our therapeutic approach. This trial offers the opportunity to provide additional clinical evidence on the potential of our technology platform for the treatment of severe chronic inflammatory diseases”, said François Meyer, chief executive officer of TxCell. “This study will support our vision to establish our cell-based therapy as a leading standard of care in severe chronic inflammatory diseases.”

About TX-RAD

TX-RAD, a type 1 regulatory T cell based immunotherapy, is TxCell’s product candidate for the treatment of joint inflammatory diseases like rheumatoid arthritis. The Tr1 cells utilized in TX-RAD are isolated from whole blood of the patient and activated by the specific antigen. The cloned Tr1 cells are expanded ex vivo before their reinjection into that same patient. The injected Tr1 cells home to sites of inflammation and are activated locally by the specific antigen, collagen Type II, a major protein present in the joints.

About TxCell SA

TxCell, a spin off of Inserm (France’s National Institute for Health and Medical Research) located in the technology park of Sophia Antipolis, near Nice, is developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need. TxCell uses a unique and proprietary technology platform based on the properties of Type 1 regulatory T lymphocytes (Tr1 cells). The company has completed enrollment of a PhI/II study in refractory Crohn’s disease patients and has reported first positive results. The company plans to initiate a PhIIb study in the same patient population and to bring a second product candidate into a PhI/II study in refractory rheumatoid arthritis patients.

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