Epistem plc and AstraZeneca Complete Plucked Ha...

MANCHESTER, England, February 5 /PRNewswire/ --     Epistem plc (LSE:EHP) 
announced today that it had successfully completed
a preliminary study with AstraZeneca for the use of its proprietary,
minimally invasive plucked human hair biomarker technology to help steer
oncology drug development. The technology includes analysing gene expression
change in RNA extracted from the bulb of cells located at the base of a
single human plucked hair. Changes in gene expression can be used to identify
biomarkers ('core gene sets') to aid decision-making in the drug development
process.



    The companies have demonstrated that single plucked hairs sampled over
multiple time points provide effective levels of RNA for gene expression
measurement. The study also showed that the process was well tolerated by
subjects and samples proved robust during shipment and storage. Over 85% of
hairs sampled were evaluable for measurement. Further analysis of single
hairs also established reliable detection of over 13,000 genes in single
hairs, which can be used to establish 'core gene sets' for biomarker drug
discovery, validation and patient selection. A joint scientific abstract of
the study was recently presented at the AACR-NCI-EORTC meeting in San
Francisco.



    The hair biomarker provides the industry with a potentially powerful tool
to measure the effects of new cancer treatments and their translation from
preclinical through to clinical phases, enabling more informed go/no go
decisions to be undertaken at an earlier stage. The identification of
appropriate biomarkers within drug development is gaining greater importance
with the launch last year of The Biomarkers Consortium founded by The
Foundation for the National Institutes of Health (FNIH), the National
Institutes of Health (NIH), the Food and Drug Administration (FDA), and the
Pharmaceutical Research and Manufacturers of America (PhRMA). AstraZeneca is
an active member of the consortium, with the consortium's aim to identify new
biomarkers that could accelerate the delivery of new clinical treatments and
medicines for prevention, early diagnosis, and treatment of disease.



    Epistem and AstraZeneca plan to explore hair follicle core gene sets
based on drug-induced gene expression in pathways of interest for specific
therapeutics. Identified gene expression changes in the hair follicle will be
linked to changes in tumours to determine drug exposure, toxicity and dose
response leading to patient selection.



    Matthew Walls, CEO, Epistem stated: "We are excited at the initial
results that our companies have made in developing an RNA based biomarker for
drug development. AstraZeneca was the first of the top tier pharmaceutical
companies to begin feasibility studies for the use of our hair biomarker
platform and the successful completion of these studies bodes well for the
proposed next steps in our joint development collaboration."



    Professor Andrew Hughes, Clinical Director of Discovery Medicine,
AstraZeneca commented "Epistem are clearly at the forefront of understanding
gene expression profiling in plucked human hair and its utility to drug
development. Our published results clearly demonstrate that the method is
both feasible and practical; and offers the promise of providing insights
into both dose and patient selection."



Additional Information

    Epistem is a biotechnology company commercialising its expertise in
epithelial stem cells in the areas of oncology, gastrointestinal diseases and
dermatological applications. Epistem develops innovative therapeutics and
biomarkers and provides contract research services to drug development
companies. The Group's expertise is focused on the regulation of adult stem
cells located in epithelial tissue, which includes the gastrointestinal
tract, skin, hair follicles, breast and prostate. Epistem does not conduct
research in the areas of embryonic stem cells or stem cell transplantation.



    Epistem operates three distinct business divisions, Contract
Research Services, Novel Therapies and Biomarkers.



Contract Research Services

    Contract Research Services provides specialised preclinical
efficacy testing primarily for drug development companies on a 'fee for
service' basis. This division on a standalone basis is cash generative and
profitable with a seven-year track record of providing testing services to
over 72 international company clients primarily in Europe and the United
States.



Novel Therapies

    Novel Therapies is focused on developing its own innovative
therapeutics. Through its discovery platform, Novel Therapies has identified
250 potential drug candidates, of which a subset are undergoing further
evaluation and characterisation as stem cell regulators for the Group's
emerging drug development pipeline.



Biomarkers

    The emerging biomarker technology leverages the Company's
knowledge of the behaviour of epithelial stem cells and drug-induced gene
expression change to measure drug effects during treatment. Changes in gene
expression can be detected within hours and at low levels of chemotherapy or
radiation. The highly sensitive Biomarker technology is based on using mRNA
extracted from the bulb of cells at the base of a single hair follicle as a
minimally invasive process to measure gene expression changes in epithelial
tissue.



Combined Business Model

    Epistem is exploiting its combined business model to advance
its own therapeutic candidates to late preclinical stage development. The
business model integrates the discovery efforts of Novel Therapies with the
efficacy testing assays of its Contract Research Services Division, to
identify and characterise new drug candidates. Revenues generated by Contract
Research Services and Biomarkers will assist in offsetting Novel Therapies'
investment requirements for the discovery and development of its lead
therapeutics. The Directors believe that licensing partnerships will be
forthcoming for therapeutics, biomarkers and dermatologicals in 2008.