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news.TxCell has received AFSSAPS, the French regulatory agency, approval for phase I/II clinical trial to evaluate the safety and efficacy of its second product candidate TX-RAD in patients with moderate to severe rheumatoid arthritis, who failed current treatments.
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TX-RAD is a type 1 regulatory T cell based immunotherapy used for the treatment of joint inflammatory diseases like rheumatoid arthritis.
The study RATS1 (Rheumatoid arthritis And Tr1 Study), an open label, 12 weeks multicenter phase I/II clinical trial, 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 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 injected to sites of inflammation and are activated locally by the specific antigen, collagen Type II, a major protein present in the joints.
TxCell chief medical officer Miguel Forte said the pre-clinical data in arthritis and the clinical results of cell based immunotherapy obtained in Crohn’s disease makes believe that TXRAD can represent an innovative and promising new treatment modality for patients with rheumatoid arthritis.
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.