Valbonne, France, June 15, 2010 – TxCell SA, a French biotechnology company developing autologous cell-based therapies using Type 1 T-regulatory lymphocytes (Tr1) for the treatment of chronic inflammatory and autoimmune diseases, today announced the successful completion of the preclinical development of its TX-RAD product for the treatment of inflammatory arthritis.
As a result of this strong preclinical data, TxCell is now preparing a Phase I/IIa clinical study with TX-RAD for the treatment of patients with moderate to severe rheumatoid arthritis. The clinical trial application should be submitted by Q3 2010.
“Preclinical pharmacology, including pharmacodynamic, pharmacokinetic and toxicology data have shown concrete evidence for the tolerability and efficacy of TX-RAD, a new investigational cell therapy product to treat inflammatory arthritis,” said Arnaud Foussat, Chief Scientific Officer at TxCell.
Future development of TX-RAD will benefit from a robust GMP (Good Manufacturing Practices) manufacturing process established during the preclinical research.
“This successful preclinical program is another important milestone in the development of the company and provides further validation of our technology platform,” said Frederic Hammel, Chief Executive Officer at TxCell. “We are now ready to submit our next Clinical Trial Application and should perform our first injection by the end of the year.”
Rheumatoid Arthritis is a chronic, often disabling disorder with a significant unmet medical need. Existing treatments still do not provide a complete answer.
TX-RAD is a preparation of autologous type 1 regulatory T cells (Tr1 cells) formulated for intravenous infusion. The Tr1 cells utilized in TX-RAD are isolated from a whole blood sample of the patient, activated by the specific target antigen, identified and expanded ex vivo before their reinjection into the patient. The injected Tr1 cells home to sites of inflammation and are activated locally by the specific antigen, collagen Type II, which is a major protein present in the joints.
TX-RAD represents a potential new treatment opportunity for patients with moderate to severe rheumatoid arthritis who do not respond to existing conventional treatments.
The strong evidence of tolerability and efficacy of this investigational product in treating rheumatoid arthritis will be further assessed through the planned clinical trial. The pre-submission documentation has already been completed and the final clinical trial application will be submitted by the end of the summer.
“This Phase I/IIa trial is planned as a dose escalation study for a first injection in Man,” said Miguel Forte, TxCell Chief Medical Officer. “The tolerability and efficacy data obtained in preclinical studies and the preliminary positive signal detected in the Phase I/IIa trial for Crohn’s disease with Tr1 cells are providing us with relevant information to select the doses and regimens for the design of this exploratory, open label Phase I/IIa trial in rheumatoid arthritis.”
About the Phase I/IIa clinical trial in rheumatoid arthritis
The planned 12 week, multicenter, open label, dose-escalation Phase I/IIa study is designed to evaluate the safety and explore efficacy of TX-RAD therapy in patients with moderate to severe rheumatoid arthritis. The study will be conducted in France and is part of the CellArthrix project.
About the CellArthrix project
The CellArhtrix project is the result of collaboration between TxCell (Valbonne), Inserm U844 of Professeur Jorgensen and the Centre Hospitalier Régional Universitaire (Montpellier) and TcLand, (Nantes).
The CellArthrix project has received official recognition from the cluster Eurobiomed and is partly funded by the Fonds Unique Interministériel (FUI), the Regions Provence Alpes Côte d’Azur and Pays de la Loire, and by the Conseil Général des Alpes Maritimes.
TxCell SA was spun out of Inserm (France's National Institute for Health and Medical Research) in 2001. The company develops an innovative immunomodulating approach, using living cells to regenerate the equilibrium of the immune system in chronic inflammatory and autoimmune diseases. TxCell products are injectable cell suspensions of therapeutic autologous antigen specific Tr1 clones.
TxCell is currently conducting its first clinical trial of a Tr1 lymphocyte-based therapy in Crohn's disease. The final results of this Phase I/IIa are expected by the end of 2010. The company is based in the Sophia Antipolis technology park, near Nice in southern France.
For more information, please visit http://www.txcell.com