Enhanced SenCeeTox® technology

14 October 2014

Cyprotex PLC

Enhanced SenCeeTox® technology

for prediction of in vitro skin sensitisation

Cyprotex PLC (AIM: CRX), a specialist ADME-Tox Contract Research Organisation (CRO), today announces significant advances in its SenCeeTox® model for the prediction of in vitro skin sensitisation.

SenCeeTox®, originally developed by CeeTox in Kalamazoo, was acquired by Cyprotex when it purchased the business and assets of CeeTox, Inc. in January 2014. SenCeeTox® is an in vitro model which assesses multiple endpoints to determine general cytotoxicity, binding of reactive compounds (one of the initial steps in skin sensitisation) and regulation of genes involved in skin sensitisation. Cyprotex has utilised its internal expertise in skin sensitisation and predictive modelling to significantly improve the predictivity of the SenCeeTox® model over the currently available in vitro approaches. Furthermore, it is one of the only in vitro models on the market which can accurately predict skin sensitisation potency for categorising into non/minimal, moderate, strong and extreme sensitisers in both 2D and 3D cellular systems.

Within the EU, there has been a complete ban on animal testing of cosmetics and personal care ingredients and finished products. This has placed a much greater emphasis on developing alternative in vitro methods. The majority of cosmetic and personal care products are applied topically to the skin, and therefore skin sensitisation is a critical part of the testing strategy before a product reaches the market. Regulatory guidelines have been drafted for two in vitro skin sensitisation methods, the Direct Peptide Reactivity Assay (known as DPRA) and KeratinoSensTM, both of which are offered as services by Cyprotex. However, these single endpoint assays only define individual mechanisms and do not categorise skin sensitisation potency. For this reason, the regulatory authorities recommend a tiered testing strategy using multiple mechanistic endpoints. SenCeeTox® addresses these concerns by monitoring multiple endpoints from a single incubation, by providing potency categorisation and exceeding the predictive capability of both DPRA and KeratinoSensTM. An additional advantage of SenCeeTox® is that it can be used either within a 2D cell-based model or in a 3D skin tissue model. The development of the 3D model is essential for testing finished products such as lotions and creams which cannot be applied directly to single layers of cells.

Commenting on the launch of the improved SenCeeTox® technology, Dr Anthony Baxter, CEO of Cyprotex said: "This improved SenCeeTox® approach provides a robust and accurate method for assessing skin sensitisation potential which is superior to existing methods currently recommended by the regulatory authorities. Cyprotex continues to lead the research in this field through its expertise in skin science and in silico modelling, providing cutting edge solutions for our customers."

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Notes to Editors

Cyprotex PLC

Cyprotex is listed on the AIM market of the London Stock Exchange (CRX). It has sites at Macclesfield and Alderley Park, both of which are near Manchester in the UK, and at Watertown, MA and Kalamazoo, MI in the US. The Company was established in 1999 and works with more than 900 partners within the pharmaceutical and biotech industry, cosmetics and personal care industry and the chemical industry. Cyprotex acquired Apredica and the assets of Cellumen Inc. in August 2010 and the combined business provides support for a wide range of experimental and computational ADME-Tox and PK services, extending from early drug discovery through to IND submission. The acquisition of the assets and business of CeeTox in January 2014 has enabled Cyprotex to expand its range of services to target the personal care, cosmetics and chemical industries. The Company's core capabilities include high quality in vitro ADME screening services, mechanistic toxicology and high content toxicology screening services, including our proprietary CellCiphr® toxicity prediction technology, predictive modelling using PBPK and QSAR techniques, including Cloe® PK for in vivo PK prediction, and a range of skin, ocular and endocrine disruption services. For more information, see www.cyprotex.com.