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 publication of the complete results of CATS1 Crohn’s disease study in Gastroenterology, the most prominent journal in the field of gastrointestinal disease, and the presentation of the long term treatment extension data at UEGW, the main European gastroenterology meeting.
CATS1 was a phase I/II study using Ovasave(R), TxCell’s lead product candidate for the treatment of Crohn’s disease. The study was a first in man, open label, multicenter phase I/II study performed to evaluate the tolerability and efficacy of Ovasave(R), an antigen-specific regulatory T cell-based immunotherapy for the treatment of patients with moderate to severe refractory Crohn’s disease. The study was designed to assess a single injection of Ovasave(R) and was subsequently amended to include multiple injections at regular intervals. The peer-reviewed published results of the single injection of Ovasave(R) 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.
“Crohn’s Disease continues to represent an unmet medical need, in particular in patients refractory to the approved biologics,” said Professor Jean-Frederic Colombel, the senior investigator from CATS1. (Lille, France). “That is why promising new treatments, like antigen-specific Treg cell therapy, need to be evaluated and could represent a significant opportunity.”
“The good tolerability in the CATS1 extension together with the apparent dose-related effect after the first injection, provide us with valuable information and support for the design of subsequent pivotal studies with Ovasave(R) in Crohn’s disease”, said Miguel Forte, TxCell’s chief medical officer.
Chief executive officer Francois Meyer confirmed the company’s full commitment to continue the development of Ovasave(R): “The acceptance of this pioneering study for publication in a prominent journal in addition to the preliminary results from the extension study encourage us to pursue the development of this very innovative approach for the treatment of refractory patients with Crohn’s disease. This data will be of great relevance to develop further treatment options for the over 160,000 people affected by severe Crohn’s disease in Europe and the US alone.”*
* According to PharMetrics Analysis, September 2008.
About the phase I/II clinical trial
The concluded 12 week, multicenter, open label, uncontrolled and dose-escalation phase I/II study was designed to evaluate the safety and efficacy of OvaSave(R) therapy in patients with severe and refractory Crohn’s disease. 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 10^6, 10^7, 10^8 and 10^9 cells. In view of the preliminary results and the apparent patient benefit, the study was extended to assess the impact of additional injections at regular intervals up to one year of exposure.
Ovasave(R), an antigen-specific type 1 regulatory T (Ag-Treg) cell based immunotherapy, is TxCell’s lead product candidate for the treatment of inflammatory bowel diseases including Crohn’s disease. The Ag-Treg cells utilized in Ovasave(R) 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.
About TxCell SA
TxCell, a spin off of Inserm (France’s National Institute for Health and Medical Research) is located in the technology park of Sophia Antipolis, near Nice in southern France. It 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 antigen-specific Type 1 regulatory T lymphocytes (Ag-Treg). The company has completed a PhI/II study in refractory Crohn’s disease patients and has reported good tolerability and positive signals of efficacy. The company plans to initiate a PhIIb study in the same patient population.