Genedrive Regulatory News (GDR)

22 May 2007 07:30

EpiStem Holdings plc22 May 2007 22nd May 2007 EpiStem Plc announce biomarker studies for new drug development with AstraZeneca EpiStem Plc (LSE: EHP), the UK epithelial stem cell company, announced todaythat it had entered into feasibility studies with AstraZeneca to use itsproprietary plucked hair biomarker technology to help guide preclinical andclinical development of new cancer drugs. EpiStem's biomarker technology is a potentially powerful tool to enable drugcompanies to measure the effects of new cancer treatments over time in aminimally invasive manner. The biomarker technology may help inform theearly-stage assessment of drugs in preclinical development thereby assisting go/no-go decisions thereby reducing the risk of an expensive drug failure in laterclinical trials. The biomarker program has evolved from the discovery by EpiStem scientists ofthe link between the stem cells in the small intestine and the hair follicle.From this knowledge, the "plucked hair" biomarker has been developed as anon-invasive tool to measure drug effects on adult epithelial stem cells andtissues. The biomarker technology works by taking plucked human hairs at various timesduring cancer treatment and analyzing the corresponding changes in geneexpression. Gene expression change in hairs can provide drug developmentcompanies with a measure of drug exposure, toxicity, dose/schedule and patientselection in preclinical and clinical drug development. This approach also hasthe potential to offer oncologists a simple means to more effectively treatcancer patients. Dr Jeff Moore, Managing Director of Novel Therapies at EpiStem said, "The FDAhas made it clear that they want new drugs to have biomarkers that show thedirect impact of that drug. We are very excited about our biomarkerdevelopments and believe that our technology will accelerate the development ofnew cancer therapeutics throughout development and is well placed to improve theeffectiveness of existing treatment regimens. Our partnership with AstraZeneca,one of the leading global pharmaceutical companies, offers an exceptionalprospect for our biomarker technology in helping to guide the development of newdrugs. Dr Moore also said "at this stage of our development, there were noforecast commercial values associated with the technology programme". Vice President of AstraZeneca's Oncology Therapy Area, Brent Vose, said, "Theability to use minimally invasive biomarkers to help guide our preclinical andclinical drug development is an important step forward for AstraZeneca's drugdevelopment programme. We have been impressed by the 'plucked hair' biomarkertechnology and look forward to working closely with EpiStem Plc in thesuccessful delivery of our joint feasibility studies." For more information please contact: Matthew WallsChief Executive Officer - EpiStem Ltd +44 (0)161 606 7258 Mike Wort, Anna DunphyMC Bio-Communications Limited +44 (0)20 7744 7711 Additional Information EpiStem is a biotechnology company commercialising adult stem cells in the areasof oncology and gastrointestinal diseases as well as cosmeceutical applications.EpiStem develops innovative therapeutics and diagnostic biomarkers and providescontract research services to drug development companies. The Group's expertiseis focused on the regulation of adult stem cells located in epithelial tissue,which includes the gastrointestinal tract, skin, hair follicles, breast andprostate. EpiStem does not conduct research in the areas of embryonic stem cellsor stem cell transplantation. EpiStem operates two distinct business divisions, Contract Research Services andNovel Therapies. Contract Research Services Contract Research Services provides specialised preclinical efficacy testingprimarily for drug development companies on a fee for service basis. Thisdivision on a standalone basis is cash generative and profitable with afive-year track record of providing testing services to over 72 internationalcompany clients primarily in Europe and the United States. Novel Therapies Novel Therapies is focused on developing its own innovative therapeutics anddiagnostic biomarkers. Through its discovery platform, Novel Therapies hasidentified 250 potential drug candidates, of which a subset will undergo furtherevaluation as stem cell regulators for the Group's emerging drug developmentpipeline. Novel Therapies is also developing its clinical diagnostic biomarkertechnology. Combined Business Model The Group is exploiting its combined business model to advance its owntherapeutic candidates to late preclinical stage development. The business modelintegrates the discovery efforts of Novel Therapies with the efficacy testingassays of its Contract Research Services Division, to identify and characterisenew drug candidates. Revenues generated by Contract Research Services willassist in offsetting Novel Therapies' investment requirements for the discoveryand development of therapeutics. In February 2007, EpiStem licensed its firstdrug candidate to a clinical development company. With the validation of theNovel Therapies discovery platform and the achievement of discovery milestones,the Directors believe that additional licensing partnerships will be forthcomingfor therapeutics, diagnostics and cosmeceuticals starting in 2008. About AstraZeneca AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $26.47 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. This information is provided by RNS The company news service from the London Stock Exchange