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Epistem plc and AstraZeneca Complete Plucked Hair Biomarker Study for Oncology Drug Development
Date:2/5/2008

MANCHESTER, England, February 5 /PRNewswire-FirstCall/ -- 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.


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SOURCE Epistem plc
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