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US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

By Gareth MacDonald+

30-Jun-2015
Last updated on 30-Jun-2015 at 13:07 GMT2015-06-30T13:07:00Z

Ovasave set for US trials after TxCell's IND Approved by US FDA
Ovasave set for US trials after TxCell's IND Approved by US FDA

TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

The candidate therapy – known as Ovasave – entered a Phase IIb trial in Europe in December in a programme that has enrolled 160 patients with severe refractory Crohn’s disease at sites in six countries.

The plan now is to extend the study to the US according to CEO Stephane Boissel, who told us: “The intention is to supply US trials from a CMO. CMO will be either US or EU, but most likely EU-based at least for 2016-2017 supply needs.”

Initially, trial supplies of Ovasave – which consists of shots of white cells harvested from the patient that have been taught to recognise disease targets – were produced at a pilot plant in Besancon, France.

However, last week , TxCell voluntarily halted production after French regulator ANSM (Agence Nationale de Sécurité du Médicament) told it environmental monitoring at the site could be improved.

TxCell said the suspension was a precautionary measure and stressed that contamination had not been detected in any products made at the site.

The firm also said that, prior to the production halt, it had already started looking for a contractor to take over Ovasave production to enable expansion of the trial programme.

If this contractor is also chosen to support the study in the US, it will need capacity to make "3 to 4 batches of Ovasave each week" Boissel said. Previously, the Besancon site had produced enough to treat only one to two trial participants each week.

Eventually, TxCell plans to build its own manufacturing facility to support late-phase clinical development of Ovasave and is assessing sites in France.

Transatlantic CRO

The US part of the Ovasave trial – which is known as CATS29 – will be run by a contract research organisation (CRO) according to COO Miguel Forte, who suggested the contractor in charge of the study in Europe is likely to be given the job.

Forte told us "The operational conduct of the study will be done by a CRO established in the US like the CRO that is conducting, together with the TxCell Clinical Operations team, the CATS29 study in Europe.

He added that: “We have the option to use the current CRO that is also established in the US, which is the preferred option for logistics perspective, or to contract with an alternative one in the US.”

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