TxCell SA, has announces 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,” said François 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.”