CIT to distribute hES based tox test in Europe

By Gareth Macdonald

- Last updated on GMT

Related tags European union

Non-clinical CRO CIT will distribute Stemina’s hES-based toxicity testing platform to pharmaceutical and cosmetics developers in Europe under an agreement announced late last week.

The deal, financial terms of which were not disclosed, will see Stemina’s DevTox human embryonic stem cell (hES) based technology used to test the toxicity of candidate compounds as an alternative to animal testing.

A CIT spokeswoman told Outsourcing-pharma that: “[The] chemical and pharmaceutical industries face a real challenge to identify the safety liabilities for their products with highly predictive fast in vitro assays.

Teratogenicity is a major safety issue and devTOX appears as the optimal alternative to the current animal testing as it is the only one to use human cell lines and to provide quantitative endpoints.”

The firm’s also plan to develop DevTox for application in client’s compliance with the European Union’s registration, evaluation, authorisation and restriction of chemicals (REACH) regulations.

“As all in vitro assays, devTOX should proceed through the ECVAM validation process before being proposed for regulatory use under REACH regulation. However, it may be used before completion of this process for screening purposes, especially for early screening of pharmaceutical teratogenicity liabilities. “

In vitro expansion

The agreement, which is likely to involve transfer of Stemina tech to CIT for European production, fits with the Evreux, France-based preclinical contract research organisation’s (CRO) recent efforts to expand in in vitro​ testing.

Earlier this year​ CIT announced its involvement in the European Commission’s “ScreenTox” project, which is focused on the development of in vitro toxicity testing technologies for pharmaceuticals and cosmetics.

At the time CIT CSO Roy Forster said that the CRO was “confident that our involvement in the project will potentiate our activity in in vitro testing​,” and added that the firm had already invested in the field.

This was echoed in comments by CIT's spokeswoman who said the addition of the DevTox platform to the firm's exisiting in vitro range will “reduce attrition during regulatory in vivo safety tests and reduce the cost of development and the number of animals used​.”

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