TxCell Receives Approval for Phase I/II Clinical Trial Extension
TxCell SA, a biotechnology company developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high unmet medical need, recently 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.
“There are limited options for the management of severe refractory Crohn’s Disease patients. We have conducted CATS1 to explore our innovative cellular-based immuno-regulatory approach for the treatment of these patients,” said Miguel Forte, Chief Medical Officer of TxCell. “The open label study extension now approved will help to address the unmet medical need in some of the severe patients recruited in CATS1.”
“We are delighted and encouraged by the investigators’ and patients’ assessment of Ovasave treatment benefit,” added Francois Meyer, Chief Executive Officer of TxCell. “We are now committed to confirm these results in a controlled Phase IIb study and to progress the development plan of our lead product candidate, Ovasave.”
Ovasave, a type 1 regulatory T cell-based immunotherapy, is TxCell’s leading product candidate for the treatment of inflammatory bowel diseases like Crohn’s Disease. The Tr1 cells utilized in Ovasave are isolated from whole blood of the patient, activated by the specific antigen, ovalbumin. The cloned Tr1 cells are expanded ex vivo before their reinjection into that same patient. The injected Tr1 cells home to sites of inflammation and are activated locally by the specific food antigen, ovalbumin.
TxCell, a spin-off of Inserm (France’s National Institute for Health and Medical Research) located in the technology park of Sophia Antipolis, near Nice in southern France, is developing cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary technology platform based on the properties of Type 1 regulatory T lymphocytes (Tr1 cells). The company has completed enrollment of a Phase I/II study in refractory Crohn’s Disease patients and has reported first positive results. The company plans to initiate a Phase IIb study in the same patient population and to bring a second product candidate into a Phase I/II study in refractory rheumatoid arthritis patients.
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