CRX.L Regulatory News (CRX)

4th September 2014

Cyprotex PLC

Cyprotex joins CiPA initiative

 Selected as testing facility for new in vitro cardiac safety testing strategies

Cyprotex PLC (AIM:CRX), a specialist ADME-Tox Contract Research Organisation (CRO), announces its membership and its selection as a testing facility in the CiPA (Comprehensive in vitro Proarrythmia Assay) initiative. The aim of the CiPA initiative is to devise new approaches for cardiac safety testing. Cyprotex plays an important role in the assessment of these new approaches and is expected to start testing for the project in October/November this year. Other partners in the initiative include the Cardiac Safety Research Consortium (CSRC), the Health and Environmental Sciences Institute (HESI), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Safety Pharmacology Society (SPS), Health Canada, the Japan National Institute of Health Sciences (NIHS) and the Pharmaceutical and Medical Devices Agency (PMDA) as well as several large Pharmaceutical companies.

The current testing strategy performed as part of a regulatory safety testing package under the ICH S7B and E14 guidelines are thought to be overtly stringent in determining proarrhythmic effects leading to potentially valuable therapies being terminated unnecessarily and not reaching the market. The new initiative is intended to address these concerns and revise the current practices used for cardiac safety testing. This will entail evaluating a novel array of nonclinical proarrhythmia assessments combined with in silico predictive modelling of cellular electrophysiological effects.

Cyprotex's Chief Executive Officer, Dr Anthony Baxter, commented, "Cyprotex is actively involved in the CiPA paradigm and is a leader in the field of in vitro cardiac safety testing, helping to determine future effective strategies for drug development.

"Cyprotex has specialist expertise in microelectrode array (MEA) testing and last year we were first to market with our eCiphrCardio service which assesses MEA activity of iPS (induced pluripotent stem) cell derived cardiomyocytes. Within the CiPA initiative, Cyprotex is involved in the Cardiomyocyte MEA sub-team which has a vital role in the evaluation and development of new testing methods.

"We look forward to commencing testing as part of the CiPA initiative in October/November this year."

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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.