Safety board clears TxCell to restart Ovasave study that was halted last year

By Gareth Macdonald

- Last updated on GMT

iStock/StanislavSalamanov
iStock/StanislavSalamanov
TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

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.

Related news

Show more

Related products

show more

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

Related suppliers

Follow us

Products

View more

Webinars