TxCell Announces Positive Preliminary Results from the Phase I/IIa Clinical Trial of OvaSave® in Crohn’s Disease
News Apr 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, has announced positive preliminary results from the ongoing Phase I/IIa clinical trial regarding OvaSave®, an investigational new drug, in patients with severe and refractory Crohn’s disease. Preliminary results from the study showed that OvaSave® 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® 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.”
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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