Cyprotex PLC Cyprotex joins CiPA initiative
September 04 2014 - 2:00AM
RNS Non-Regulatory
TIDMCRX
Cyprotex PLC
04 September 2014
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."
For further information:
Cyprotex PLC Tel: +44 (0) 1625 505
100
Dr Anthony Baxter, Chief Executive Officer ir@cyprotex.com
John Dootson, Chief Financial Officer www.cyprotex.com
Mark Warburton, Chief Operating Officer
and Legal Counsel
N+1 Singer (Nomad and broker to Cyprotex) Tel: +44 (0)20 7496 3000
Shaun Dobson shaun.dobson@n1singer.com
Jen Boorer jennifer.boorer@n1singer.com
www.n1singer.com
FTI Consulting Tel: +44 (0) 20 3727 1000
Simon Conway cyprotex@fticonsulting.com
Mo Noonan www.fticonsulting.com
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(R) toxicity prediction technology, predictive modelling
using PBPK and QSAR techniques, including Cloe(R) PK for in vivo PK
prediction, and a range of skin, ocular and endocrine disruption
services. For more information, see www.cyprotex.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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