TxCell SA has announced that the United States Food and Drug Administration (FDA) has accepted TxCell’s Investigational New Drug (IND) application for the company’s lead product, Ovasave®, currently in a phase 2b clinical trial for the treatment of patients with refractory Crohn’s disease. The study is currently one of largest ever-controlled studies for a personalized T cell immunotherapy product.
The activation of the IND authorizes TxCell to extend the CATS29 study to the United States. The CATS29 study is currently on-going in Europe following its start in December 2014. There are currently 30 study sites operating the study in 6 countries in the EU. It has been designed to include 160 severe refractory Crohn’s disease patients.
The extension of this study to U.S. sites could be initiated in the first part of 2016. Ovasave materials manufactured in a US or EU GMP facility will be required to start enrolment in a clinical trial under the IND.
“This active US IND is a very important milestone for TxCell as it is the first ever obtained by the Company with one of its products,” said Stéphane Boissel, Chief Executive Officer of TxCell. “It is a sign of maturity for TxCell and, importantly, for its cellular immunotherapy technology based on regulatory T cells products, a field in which our Company is a pioneer and a world leader.”
“The receipt of the IND for the CATS29 study with Ovasave from the FDA will give TxCell an option to extend the trial in the US. The extension to this trial, already one of largest ever-controlled studies for a personalized T cell immunotherapy product, could give additional resources, namely in terms of patient recruitment, to accelerate the study,” said Miguel Forte, Chief Operating Officer of TxCell.
Forte continued, “The IND provides further opportunities for Ovasave to progress smoothly and rapidly to phase 3 and commercialization. It also opens the possibility to assess the benefit of our antigen specific T regulatory cell therapy in refractory Crohn’s disease patients who have no alternative treatment options, from US sites.”