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TxCell Presents Immuno-Monitoring Results of Its Phase I/II Clinical Trial With Antigen-Specific Treg Cells in Crohn's Disease


2/21/2012 9:42:18 AM

Valbonne, France, February 21, 2012 - TxCell SA, a biotechnology company developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical need, announces today immuno-monitoring results of the phase I/II study in Crohn’s disease (CATS1) with its leading product candidate Ovasave(R). The results of this study, performed on 20 patients, were presented at the seventh European Crohn’s and Colitis Organization meeting, in Barcelona, held February 16 -18.

The CATS1 study was a first in man, open label, multicenter phase I/II study in France to evaluate the tolerability and efficacy of Ovasave(R), an antigen-specific regulatory T cell-based immunotherapy. The CATS1 study included patients with severe chronic active Crohn’s disease, who had failed current treatments, including multiple biologics. An immuno-monitoring study of CATS1 patients was performed in order to evaluate the potential impact of Ovasave(R) on the patient’s immune system. Results indicate that the Ovasave(R) treatment impacted the immune system specifically in patients responding to Ovasave(R) with a decrease in blood pro-inflammatory monocytes subpopulations and with an inhibition of the immune response to Ovasave(R)-specific antigen. The correlation between patient’s clinical improvement and antigen-specific immuno-suppression is supportive of the mechanism of action of Ovasave(R), composed of antigen-specific Treg cells.

“The antigen-specificity of the Treg cells in Ovasave(R) represents an important component of their therapeutic potential,” said Arnaud Foussat, chief scientific officer at TxCell. “Our immuno-monitoring results indicate that antigen-specific immune suppression was obtained in patients responding to the treatment.”

“In addition to the positive clinical results of the phase I/II, the immuno-monitoring data adds important information to the mechanism of action of Ovasave(R),” added François Meyer, chief executive officer at TxCell. “The confirmation of this antigen-specific suppressive activity in the planned phase II clinical trial in the same refractory patient population could become an important marker to assess the patient’s biologic response to treatment.”

About the phase I/II clinical trial

The concluded 12 week, multicenter, open label, uncontrolled and dose-escalation phase I/II study was designed to evaluate the safety and efficacy of OvaSave(R) therapy in patients with severe and refractory Crohn’s disease. The product was injected intravenously as a single administration to patients with chronic active Crohn's disease. Six sites in France enrolled patients distributed into four different groups with doses of 10^6, 10^7, 10^8 and 10^9 cells.

About Ovasave

Ovasave, an antigen-specific type one regulatory T (Ag-Treg) cell based immunotherapy, is TxCell’s leading product candidate for the treatment of inflammatory bowel diseases like Crohn’s disease. The Ag-Treg cells utilized in Ovasave are isolated from whole blood of the patient, activated by the specific antigen, ovalbumin. The cloned Ag-Treg cells are expanded ex vivo before their reinjection into that same patient. The injected Ag-Treg cells home to sites of inflammation and are activated locally by the specific food antigen, ovalbumin.

About TxCell SA

TxCell, a spin off of Inserm (France’s National Institute for Health and Medical Research) is located in the technology park of Sophia Antipolis, near Nice in southern France. It is developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary technology platform based on the properties of antigen-specific type one regulatory T lymphocytes (Ag-Treg). The company ended in 2011 a phI/II study in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy. 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.

For more information, please visit http://www.txcell.com

Mark Tidmarsh

ANDREW LLOYD & ASSOCIATES

http://www.ala.com

mark@ala.com

Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND

Tel: +44 1273 675100 Fax: +44 1273 675400

55 rue Boissonade 75014 Paris FRANCE

Tel: +33 1 56 54 07 00 Fax: +33 1 56 54 07 01

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