Antigen-Specific Treg Cells For Crohn's Disease Treatment - TrialEditor's Choice
Main Category: Crohn's / IBD
Article Date: 31 Oct 2011 - 8:00 PDT
Antigen-Specific Treg Cells For Crohn's Disease Treatment - Trial
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TxCell presents final positive results of the phase I/II clinical trial with antigen-specific Treg cells in Crohn's disease.
At the United European Gastroenterology Week (UEGW) in Stockholm, TxCell SA presented the final positive results of its phase I/II study of OvaSave ® developed for the treatment of patients with severe chronic active Crohn's disease (CATS-1). TxCell SA is a French biotechnology company that develops Treg cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical needs.
Crohn's disease is a chronic, inflammatory bowel disease that can affect any part of the gastrointestinal tract from mouth to anus, causing a wide variety of symptoms that can be disabling. So far, existing treatments do not provide satisfactory relief to patients.
The CATS-1 study was the first human, open label, uncontrolled, multi center phase I/II study to assess the tolerability and efficacy of OvaSave®, an antigen-specific regulatory T cell-based immunotherapy in 20 patients with severe and chronic and relapsing active Crohn's disease, who had failed current treatments, including multiple biologics. During the 12-week study period, patients from six sites in France were divided into four groups to receive a single dose of either 106, 107, 108 or 109 cells of OvaSave® injected intravenously.
The trial results showed that OvaSave(R) is well tolerated and displayed a positive efficacy trend, with 40% of all patients responding positively five weeks after treatment.
A significant 75% of patients responded positively in the best dose group, with 38% going into remittance five weeks following treatment. Based on the results TxCell plans to continue its clinical development of OvaSave® with a controlled phase II study.
François Meyer, chief executive officer of TxCell, commented: "The results indicate the potential of our antigen-specific Treg cell approach for the management of multiple chronic inflammatory diseases. 160,000 people are affected by severe Crohn's disease in Europe and US. Confirmation of these positive results will provide a new hope for patients in a refractory state of the disease."
Miguel Forte, chief medical officer of TxCell added: "The open label evidence on the tolerance profile and the dose-related significant clinical effect are very encouraging. This will be the basis for the next steps in the clinical development plan of OvaSave® in Crohn's disease. The company will initiate a phase II study in the same patient population."
Written by: Petra Rattue
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