MANCHESTER, England, Sept. 20 /CNW/ - 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
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
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 further information:
For further information: Matthew Walls, Chief Executive Officer, EpiStem
Ltd, +44-(0)-161-606-7258; Mike Wort, Anna Dunphy, MC Bio-Communications
Limited, +44-(0)-20-7744-7711; Thilo Hoffmann, Landsbanki Securities (UK)