TxCell Announces Positive Preliminary Results from the Phase I/IIa Clinical Trial of OvaSave(R) in Crohn's Disease
Valbonne, France, April 29, 2010 – TxCell SA, a French biotechnology company developing autologous cell-based therapies using Type 1 T-regulatory lymphocytes (Tr1) for the treatment of chronic inflammatory and autoimmune diseases, today announced positive preliminary results from the ongoing Phase I/IIa clinical trial regarding OvaSave(R), an investigational new drug, in patients with severe and refractory Crohn’s disease. Preliminary results from the study showed that OvaSave(R) is well-tolerated and that an encouraging efficacy signal has been observed.
The announcement comes as TxCell is planning a Series C financing round in the near future as part of its clinical development program. This will focus on confirming these positive results and providing a human proof of concept for inflammatory bowel diseases and rheumatoid arthritis.
“The positive signal observed in this study is an excellent start to the process of demonstrating the clinical benefit of our cell based therapy,” said Frederic Hammel, Chief Executive Officer at TxCell. “It also creates a real hope for severe refractory patients.”
Crohn’s disease is a chronic, often disabling disorder with a significant unmet medical need since existing treatments still do not provide a complete answer. OvaSave(R) is a new advanced medicinal product in clinical development based on autologous Tr1 cells. It represents a potential new treatment opportunity for patients with severe Crohn’s disease who do not respond to existing conventional treatments.
These initial results mean that TxCell can proceed with designing a Phase IIb trial. "The Phase I/IIa trial was planned as a dose escalation study for a first injection in Man,” said Miguel Forte, TxCell Chief Medical Officer. “The preliminary evidence of tolerability and positive efficacy signal detected in this study is providing us with relevant data to select the doses and regimens for the design of an European Phase IIb randomized controlled confirmatory trial in Crohn’s disease, as well as for two exploratory, open label Phase I/IIa trials in Rheumatoid Arthritis and in Ulcerative Colitis.”
TxCell will attend BIO Chicago, USA, booth 3712, France Pavillon, May 3-6.
About the Phase I/IIa clinical trial
The ongoing 12 week, multicenter, open label, uncontrolled and dose-escalation Phase I/IIa study is designed to evaluate the safety and efficacy of OvaSave(R) therapy in patients with severe and relapsing Crohn’s disease. The product is injected intravenously as a single administration to patients with chronic active Crohn's disease. Six sites in France enrolled patients distributed into four different cohorts with doses of 106, 107, 108 and 109 cells.
About TxCell
TxCell SA was spun out of Inserm (France's National Institute for Health and Medical Research) in 2001. The company develops an innovative immunomodulating approach, using living cells to regenerate the equilibrium of the immune system in chronic inflammatory and autoimmune diseases. TxCell products are injectable cell suspensions of therapeutic autologous antigen specific Tr1 clones.
The Afssaps (the French Agency for Health Product Safety) authorized the company to start its first clinical trial of a Tr1 lymphocyte-based therapy in Crohn's disease. The final results of this Phase I/IIa are expected by the end of 2010. The firm is based in the Sophia Antipolis technology park, near Nice in southern France.
For more information, please visit http://www.txcell.com