The study – named CATS29 – stopped last year after regulator ANSM (Agence nationale de sécurité du medicament) raised concerns about the potential risk of microbial contamination at a manufacturing facility in Besancon where Ovasave was being produced.
Since then TxCell has hired contract manufacturers - Caladrius Biosciences’ subsidiary PCT in the US and MaSTherCell in Belgium – and amended the trial protocol.
In addition, the data and safety monitoring board (DSMB) overseeing CATS29 conducted a review of all available data from previously treated patients.
A spokeswoman for TxCell told us approval to restart study was granted by European authorities through the Voluntary Harmonisation Procedure (VHP) based on the DSMB's recommendations.
She added that: "The DSMB is made up of four independent experts in the field, using unblinded data."
TxCell plans to resume CATs29 as soon as possible and expects top-line data within 21 months of the restart.
Ovasave
The news follows just a few months after TxCell regained full rights to Ovasave from cell therapy development firm Trizell.
Trizell had been working on Ovasave – including running the CATS29 study - since January 2014 when TxCell and partner Ferring Pharmaceuticals handed over development rights.
However, last December TxCell paid Trizell €15m ($15.9m) to regain full rights to the product. At the time TxCell outlined how it would modify the trial protocol.
The firm said while it would retain the primary endpoint of a Crohn's disease activity index (CDAI) response to a 1 million cell dose of the product vs placebo it would omit the dose-ranging arms of the trial.