Chiltern - Spectratox Drug Photoxicity Collaboration Celebrates 25 Years

By Chiltern, PRNE
Sunday, February 27, 2011

LONDON, February 28, 2011 - The staffs of Chiltern International Limited (Chiltern), a global
contract research organization (CRO), and Spectratox Limited, celebrate the
25 year mark of their successful collaboration in Drug Phototoxicity.

Chiltern Early Phase and Spectratox have worked together using a
validated and regulatory accepted in vivo human study method for the
assessment of drug phototoxicity. The history of this collaboration can be
traced through their multiple publications in peer reviewed journals.

"The success story of this methodology is not just measured in
publications," stated Dr Brian Sanderson, Medical Director, Chiltern Early
Phase. "It is measured in the success we have had in helping new drugs
continue their developmental journey for areas of therapeutic need."

Professor James Ferguson, Head of the Academic Department of Dermatology,
University of Dundee, and CEO of Spectratox, explained, "The evolution of
randomized controlled trials has been in response to industry and regulatory
requirements. Our trials, which tend to be conducted prior to Phase 3,
produce data that defines the phototoxic risk in man in terms of severity and
causal wavelengths as well as providing an understanding of the likelihood of
ocular phototoxicity. Where phototoxicity is found, advice on protective
measures to enable future development of the compound is an important aspect
of our work."

Dr Sanderson added, "New study designs have been introduced to act as
initial "screening" in man for drugs with potential phototoxicity. The new
designs have evolved in response to the growing demand to assess this earlier
in clinical drug development. The benefits are savings in both time and cost
whilst remaining scientifically robust."

Glenn Kerkhof, Chiltern CEO, commented, "This 25 year collaboration is
cause for celebration when we look back and realize the successes reached as
well as what is presently being accomplished together. We very much look
forward to what the next 25 years will bring in advancing drug development

Company profiles

About Chiltern:

Established in 1982, Chiltern is a leading global Contract Research
Organization with extensive experience conducting and staffing international
Phase I to Phase IV clinical trials across a broad range of therapeutic areas
for a wide variety of clients. Chiltern has conducted trials in more than 40
countries, has 24 offices and legal entities within 20 countries, resources
in 37 countries and employs nearly 1,400 people globally. Chiltern provides
Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and
Regulatory Affairs and Resourcing Solutions services. Further information:

About Spectratox:

Spectratox, although formally established in 2008, came about from a
group of staff within the Photobiology Unit who had been collaborating with
the Chiltern staff on drug phototoxicity work in Scotland since the mid
1980s. Together they developed an evidence-based methodology for studying
phototoxicity in clinical volunteers. Professor Ferguson has 30 years
experience advising on the need for such work. The staff at Spectratox are
also expert in pre-clinical laboratory data analysis; clinical 'healthy
volunteer' studies and post-study testing; advice on product labelling and
clinical management.

Phototoxicity testing is carried out on the premises of the National
Photobiology Unit, Ninewells Hospital and Medical School, a part of NHS
Tayside (although Spectratox Ltd. is an independent company). Further

    For More Information Contact:

    Natalie Chong, Marketing Director    Susan Ojanen, Marketing Associate
    Chiltern International Ltd.          Chiltern International Inc.
    UNITED KINGDOM                       USA
    Tel:  +44-(0)-1753-512-000           Tel:  +1-423-968-9533
    Email:    Email:

Natalie Chong, Marketing Director, +44-(0)-1753-512-000, natalie.chong at, or Susan Ojanen, Marketing Associate, +1-423-968-9533, susan.ojanen at, both of Chiltern

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