EpiStem Successfully Complete First Year Of Muc...
LONDON and MANCHESTER, England, September 20 /PRNewswire/ -- 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.
Additional Information
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
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.
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