MANCHESTER, England, September 20 /PRNewswire-FirstCall/ -- EpiStem (LSE: EHP) announced today that it has completed the first year of mucositis efficacy-testing services for potential biodefense drugs, and are about to embark upon an extensive drug screening programme over the coming year.
The National Institutes of Health (NIH) Medical Countermeasures against Radiological and Nuclear Threats (MCART) programme leads the U.S. effort to develop treatments for radiation sickness following a nuclear terrorist attack. EpiStem is a major provider of services to identify novel drugs that can improve the 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 oncology supportive care. These assays provide quantitative and mechanistic data to assess the efficacy of novel drug candidates, enabling companies to make informed decisions regarding the progression of their preclinical pipeline.
Dr Tom MacVittie, who co-ordinates the programme at the University of Maryland School of Medicine said: "Gastrointestinal acute radiation syndrome (GI-ARS) is a massive, currently untreatable, problem following high-dose radiation exposure. Agents that mitigate these effects could reduce sickness and hopefully prevent fatalities. The tests performed by EpiStem are also likely to identify agents with oncology supportive care applications - agents that will reduce the severe ulceration and diarrhoea (mucositis) experienced by patients during radio- 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 first three test drugs have successfully been completed, with approx 10 more with an estimated value of US$0.75m revenue for the Company in the pipeline for the coming year. The programme is forecast to extend over the next 3 years. EpiStem is also now working to gain GLP compliance for the next phase of the project, in order 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, the Armed Forces Radiobiology Research Institute at Bethesda, Fast Track Drugs and Biologics LLC, Aotech, LLC, and Information Management Consultants, Inc.
EpiStem is a biotechnology company commercialising adult stem cells in the areas of oncology and gastrointestinal diseases as well as cosmeceutical applications. EpiStem develops innovative therapeutics and diagnostic 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 two distinct business divisions, Contract Research Services and Novel Therapies.
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 five-year track record of providing testing services to over 72 international company clients primarily in Europe and the United States.
Novel Therapies is focused on developing its own innovative therapeutics and diagnostic biomarkers. Through its discovery platform, Novel Therapies has identified 250 potential drug candidates, of which a subset will undergo further evaluation as stem cell regulators for the Group's emerging drug development pipeline. Novel Therapies is also developing its clinical diagnostic biomarker technology.
Combined Business Model
The Group 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 will assist in offsetting Novel Therapies' investment requirements for the discovery and development of therapeutics. In February 2007, EpiStem licensed its first drug candidate to a clinical development company. With the validation of the Novel Therapies discovery platform and the achievement of discovery milestones, the Directors believe that additional licensing partnerships will be forthcoming for therapeutics, diagnostics and cosmeceuticals starting in 2008.
For more information please contact:
Chief Executive Officer
Mike Wort, Anna Dunphy
MC Bio-Communications Limited
Landsbanki Securities (UK) Limited
|SOURCE Epistem Ltd|
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