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EpiStem Announce Biomarker Studies for Drug Development with AstraZeneca

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EpiStem Plc has announced that it had entered into feasibility studies with AstraZeneca to use its proprietary plucked hair biomarker technology to help guide preclinical and clinical development of new cancer drugs.

EpiStem's biomarker technology is a potentially powerful tool to enable drug companies to measure the effects of new cancer treatments over time in a minimally invasive manner. The biomarker technology may help inform the early-stage assessment of drugs in preclinical development thereby assisting go/no-go decisions thereby reducing the risk of an expensive drug failure in later clinical trials.

The biomarker program has evolved from the discovery by EpiStem scientists of the link between the stem cells in the small intestine and the hair follicle. From this knowledge, the plucked hair biomarker has been developed as a non-invasive tool to measure drug effects on adult epithelial stem cells and tissues.

The biomarker technology works by taking plucked human hairs at various times during cancer treatment and analyzing the corresponding changes in gene expression. Gene expression change in hairs can provide drug development companies with a measure of drug exposure, toxicity, dose/schedule and patient selection in preclinical and clinical drug development. This approach also has the potential to offer oncologists a simple means to more effectively treat cancer patients.

Dr Jeff Moore, Managing Director of Novel Therapies at EpiStem said, "The FDA has made it clear that they want new drugs to have biomarkers that show the direct impact of that drug. We are very excited about our biomarker developments and believe that our technology will accelerate the development of new cancer therapeutics throughout development and is well placed to improve the effectiveness of existing treatment regimens. Our partnership with AstraZeneca, one of the leading global pharmaceutical companies, offers an exceptional prospect for our biomarker technology in helping to guide the development of new drugs. Dr Moore also said "at this stage of our development, there were no forecast commercial values associated with the technology programme".

Vice President of AstraZeneca's Oncology Therapy Area, Brent Vose, said, "The ability to use minimally invasive biomarkers to help guide our preclinical and clinical drug development is an important step forward for AstraZeneca's drug development programme. We have been impressed by the 'plucked hair' biomarker technology and look forward to working closely with EpiStem Plc in the successful delivery of our joint feasibility studies."