TxCell is now preparing a Phase I/IIa clinical study with TXRAD
for the treatment of patients with moderate to severe Rheumatoid Arthritis. The clinical trial application should be submitted by Q3 2010.
TX-RAD is a preparation of autologous type 1 regulatory T cells (Tr1 cells) formulated for intravenous infusion. The Tr1 cells utilised 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.
Future development of TX-RAD is expected to benefit from a GMP (Good Manufacturing Practices) manufacturing process established during the preclinical research.
Arnaud Foussat, chief scientific officer at TxCell, said: “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.”
Frederic Hammel, CEO at TxCell, said: “This successful preclinical program is another important milestone in the development of the company and provides further validation of our technology platform. We are now ready to submit our next Clinical Trial Application and should perform our first injection by the end of the year.”
Miguel Forte, chief medical officer of TxCell, said: “This Phase I/IIa trial is planned as a dose escalation study for a first injection in Man. 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.”