TxCell receives approval for extension of phase I/II clinical trial
in Crohn’s disease
26 May 2011
TxCell SA, a biotechnology company developing cell-based
immunotherapies for the treatment of severe chronic inflammatory
diseases with high unmet medical need, announces today 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.”
About 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.
Source: TxCell SA