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Epistem plc and AstraZeneca Complete Plucked Hair Biomarker Study for Oncology Drug Development

Wednesday, February 6, 2008 General News J E 4
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MANCHESTER, England, February 5 Epistem plc(LSE:EHP) announced today that it had successfully completed a preliminarystudy with AstraZeneca for the use of its proprietary, minimally invasiveplucked human hair biomarker technology to help steer oncology drugdevelopment. The technology includes analysing gene expression change in RNAextracted from the bulb of cells located at the base of a single humanplucked 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 overmultiple time points provide effective levels of RNA for gene expressionmeasurement. The study also showed that the process was well tolerated bysubjects and samples proved robust during shipment and storage. Over 85% ofhairs sampled were evaluable for measurement. Further analysis of singlehairs also established reliable detection of over 13,000 genes in singlehairs, which can be used to establish 'core gene sets' for biomarker drugdiscovery, validation and patient selection. A joint scientific abstract ofthe study was recently presented at the AACR-NCI-EORTC meeting in SanFrancisco.

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

Epistem and AstraZeneca plan to explore hair follicle core gene setsbased on drug-induced gene expression in pathways of interest for specifictherapeutics. Identified gene expression changes in the hair follicle will belinked to changes in tumours to determine drug exposure, toxicity and doseresponse leading to patient selection.

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

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

Additional Information

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

Epistem operates three
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