Genedrive Regulatory News (GDR)

1 Apr 2008 10:31

EpiStem Holdings plc01 April 2008 For Immediate Release: April 1st 2008 Epistem to Provide Preclinical Efficacy Testing Services for ExponentialBiotherapies Epistem (LSE:EHP) announced today that Exponential Biotherapies, Inc (EBI). ofVirginia, USA, have contracted Epistem to provide their specialised preclinicalefficacy testing services for agents likely to protect the gastrointestinaltract against radiation damage. The first compound that Epistem will assess isEBI's lead candidate drug, EA-230, which is a small peptide immunoregulator,which has shown the potential to treat (minimise) radiation insult and couldtherefore be administered following a terrorist nuclear attack to reduce thelevel of intestinal related radiation sickness. Epistem is a world leader in supplying assays that measure qualitatively andquantitatively the effects of radiation damage on the stem cells in the gut.Epistem's assays show the effects of agents developed to protect the verysensitive cells of the gut. These assays were chosen by the National Institutesof Health (NIH) Medical Countermeasures against Radiological and Nuclear Threats(MCART) programme and Epistem also works with a number of pharmaceuticalcompanies developing new drugs candidates with the potential to treat mucositis,the erosion of the lining of the mouth and gut, which is a very common sideeffect of radiation therapy used during cancer treatment. The assays providequantitative and mechanism of action data to assess the efficacy of novel drugcandidates, and help define optimum dose scheduling for progression to theclinical phases in this very important area of oncology supportive care. Dr Zsolt Harsanyi, the Chairman and Chief Executive of Exponential Biotherapies,Inc. said "Epistem's well established assays and unrivalled expertise in thefield of gastrointestinal epithelial radiation toxicity are extremely valuableto us in confirming the potential of EA-230 as a therapeutic treatment forradionuclear attack". Dr Catherine Booth, head of Epistem's contract research division commented: "Weare looking forward to working with EBI to assess the therapeutic potential ofEA-230. If it is able to improve gastrointestinal wound healing followingradiation exposure it may have widespread applications in biodefence, oncologysupportive care (the area for which we first developed and validated theseassays), and possibly in other related intestinal wound healing situations, suchas inflammatory bowel disease." For further information, please contact: Matthew Walls +44 (0)161 606 7258 CEO Epistem Ltd. Mike Wort / Anna Dunphy +44 (0) 207 861 3838 Financial PR/IR De Facto Communications Notes to Editors: About Epistem Epistem is a biotechnology company commercialising its expertise in epithelialstem 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 gastrointestinal tract,skin, hair follicles, breast and prostate. Epistem does not conduct research inthe 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 testingprimarily for drug development companies on a 'fee for service' basis. Thisdivision on a standalone basis is cash generative and profitable with aseven-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.Through its discovery platform, Novel Therapies has identified 250 potentialdrug candidates, of which a subset are undergoing further evaluation andcharacterisation as stem cell regulators for the Group's emerging drugdevelopment pipeline. Biomarkers The emerging biomarker technology leverages the Company's knowledge of thebehaviour of epithelial stem cells and drug-induced gene expression change tomeasure drug effects during treatment. Changes in gene expression can bedetected within hours and at low levels of chemotherapy or radiation. The highlysensitive Biomarker technology is based on using mRNA extracted from the bulb ofcells at the base of a single hair follicle as a minimally invasive process tomeasure gene expression changes in epithelial tissue. Combined Business Model Epistem is exploiting its combined business model to advance its own therapeuticcandidates to late preclinical stage development. The business model integratesthe discovery efforts of Novel Therapies with the efficacy testing assays of itsContract Research Services Division, to identify and characterise new drugcandidates. Revenues generated by Contract Research Services and Biomarkers willassist in offsetting Novel Therapies' investment requirements for the discoveryand development of its lead therapeutics. The Directors believe that licensingpartnerships will be forthcoming for therapeutics, biomarkers anddermatologicals in 2008. About Exponential Biotherapies, Inc. Exponential Biotherapies, Inc. ("EBI") is a Virginia based drug discovery anddevelopment company with a growing pipeline of novel small molecule drugs totreat a wide range of severe inflammatory disorders such as septic shock, renalfailure, radiation sickness and avian influenza. These compounds represent a newclass of immune regulating therapeutic agents. The Company's first candidatedrug, EA-230, is about to enter Phase II clinical trials following a successfulPhase I in which the drug was safely tolerated in both single and multi-dosestudies as well as the LPS proof of concept, Phase I Expansion. The Company has licensed a family of chemically synthesized biomolecules (the "Compounds") that regulate the immune response. These biomolecules can eitherincrease or decrease the activity of the immune system by affecting the activityof one or more of the components of the immune cascade. This information is provided by RNS The company news service from the London Stock Exchange