Genedrive Regulatory News (GDR)

20 Sep 2007 07:01

EpiStem Holdings plc20 September 2007 For release: 20 September 2007 EpiStem Successfully Complete First Year Of Mucositis Tests For NIH Biodefence Programme (Manchester, UK) EpiStem (LSE:EHP) announced today that it has completed thefirst year of mucositis efficacy-testing services for potential biodefensedrugs, and are about to embark upon an extensive drug screening programme overthe coming year. The National Institutes of Health (NIH) Medical Countermeasures againstRadiological and Nuclear Threats (MCART) programme leads the U.S. effort todevelop treatments for radiation sickness following a nuclear terrorist attack.EpiStem is a major provider of services to identify novel drugs that can improvethe repair of the gastrointestinal (GI) tract following exposure to irradiation. There are currently no medications approved by the FDA to treat this syndrome. EpiStem is an established provider of similar GI assays for oncologysupportive care. These assays provide quantitative and mechanistic data toassess the efficacy of novel drug candidates, enabling companies to makeinformed decisions regarding the progression of their preclinical pipeline. Dr Tom MacVittie, who co-ordinates the programme at the University of MarylandSchool of Medicine said: "Gastrointestinal acute radiation syndrome (GI-ARS) isa massive, currently untreatable, problem following high-dose radiationexposure. Agents that mitigate these effects could reduce sickness and hopefullyprevent fatalities. The tests performed by EpiStem are also likely to identifyagents with oncology supportive care applications - agents that will reduce thesevere ulceration and diarrhoea (mucositis) experienced by patients duringradio- and chemo-therapy". Dr Catherine Booth, head of EpiStem's contract research division commented: "After completion of a series of validatory assays, initial studies on firstthree test drugs have successfully been completed, with approx 10 more with anestimated value of US$0.75m revenue for the Company in the pipeline for thecoming year. The programme is forecast to extend over the next 3 years. EpiStemis also now working to gain GLP compliance for the next phase of the project, inorder to help the consortium develop drugs for FDA approval in future years". Other members of the Consortium include the University of Maryland, Baltimore,the University of Illinois at Chicago, Indiana University at Indianapolis, theArmed Forces Radiobiology Research Institute at Bethesda, Fast Track Drugs andBiologics LLC, Aotech, LLC, and Information Management Consultants, Inc. 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 Thilo HoffmannLandsbanki Securities (UK) Limited +44 (0) 20 7426 9000 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. This information is provided by RNS The company news service from the London Stock Exchange