Clinical Trials

Date: 2012-10-24

Type of information: Results

phase: 1-2

Announcement: publication of CATS1 study results in Gastroenterology
presentation of the long term treatment extension data at UEGW

Company: TxCell (France)

Product: OvaSave® (antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy)

Action mechanism:

• cell therapy/immunotherapy product. OvaSave® is an antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy. 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.

Disease: Crohn's disease

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Country: France

Trial details:

• The CATS-1 study was a first in man, open label, multicenter phase I/II study in France to evaluate the tolerability and efficacy of OvaSave®, an antigen-specific regulatory T cell-based immunotherapy. The CATS-1 study was for patients with severe chronic active Crohn’s disease, who had failed current treatments, including multiple biologics. 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 10⁶, 10⁷, 10⁸ and 10⁹ cells.

Latest news:

• • On October 24, 2012, TxCell, a biotechnology company developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases has announced the publication of the complete results of CATS1 Crohn’s Disease study in Gastroenterology, and the presentation of the long term treatment extension data at UEGW, the main European gastroenterology meeting. The peer-reviewed published results of the single injection of Ovasave® indicated a good tolerability and an apparent dose-related effect. The one-year extension data now presented, also show good tolerability and are judged as beneficial to the patients. • On February 21, 2012, TxCell has presented immuno-monitoring results of the phase I/II study in Crohn's disease (CATS1) with its leading product candidate Ovasave®. Results indicate that the Ovasave® treatment impacted the immune system specifically in patients responding to Ovasave® with a decrease in blood pro-inflammatory monocytes subpopulations and with an inhibition of the immune response to Ovasave®-specific antigen. The correlation between patient's clinical improvement and antigen-specific immuno-suppression is supportive of the mechanism of action of Ovasave®, composed of antigen-specific Treg cells. The results of this study, performed on 20 patients, were presented at the 7th European Crohn's and Colitis Organization meeting, in Barcelona, held February 16 -18. • On October 25, 2011,TxCell has announced the presentation of final positive results of the phase I/II study in Crohn’s disease (CATS-1) with its leading product candidate, OvaSave®. The results of this study, performed on 20 patients, were announced at the United European Gastroenterology Week (UEGW) in Stockholm, held Oct 22 to 26. The results presented at the United European Gastroenterology Week show that OvaSave® is well tolerated. The results also showed a positive efficacy signal, with 40 per cent of the patients positively responding five weeks after treatment in the overall population group. This positive effect was particularly relevant in the best dose group with 75 per cent of patients responding and 38 per cent remitting five weeks after treatment. The present evidence has led TxCell to plan the continuation of the clinical development of OvaSave® for the treatment of Crohn’s disease with a controlled phase II study. • On May 18, 2011, TxCell  has announced the approval by AFSSAPS, the French regulatory agency, of its application to extend treatment of patients included in the Crohn’s Disease Phase I/II study (CATS1) with Ovasave®, a type 1 regulatory T cell based immunotherapy. CATS1 (Crohn And Tr1 Study) is a phase I/II trial designed to evaluate the tolerability and explore the efficacy of Ovasave in patients with severe chronic active Crohn’s Disease, who failed current treatments, including biologics. In the first part of the study completed in April 2010, Ovasave® administration was well tolerated and showed evidence of a beneficial effect in the overall population of patients. The now approved extension of CATS1 is destined to address the requests from Investigators of continuing treatment in patients that benefited from the initial Ovasave® administration.

Is general: Yes