Research Update
ReNeuron Group plc
06 February 2006
ReNeuron announces further positive pre-clinical efficacy data with ReN001 stem
cell therapy for stroke
Guildford, UK, 6 February 2006: ReNeuron Group plc (LSE: RENE.L) today announces
that it has generated further positive pre-clinical efficacy data with its
ReN001 stem cell therapy for stroke. These follow-on studies were undertaken in
validated rodent models of stroke equivalent to those used in the original
efficacy studies undertaken by the Company. The delivery method and implant
location of the ReN001 cells in the brain were selected to mimic as far as
possible the protocols that are likely to be followed in human clinical trials.
Additionally, the ReN001 cells used in these follow-on studies were drawn from
production lots manufactured to cGMP1 standard, equivalent to those that will be
used in clinical trials. The follow-on studies were designed to test the
effects of different cell doses on efficacy.
The results successfully replicated the positive effects of ReN001 at an
equivalent dose to that used in the original efficacy studies. Furthermore, and
importantly, the new studies showed a clear dose-ranging effect, indicating that
a higher dose has the potential to reverse both the sensory and motor symptoms
associated with stroke disability.
These new results will be presented at the US Center for Business Intelligence's
2nd Conference on Commercializing Stem Cells for Therapeutic Applications in
Cambridge, MA, USA on 9-10 March. They will also form part of the Company's
IND2 data package to support its impending application to the FDA3 to commence
initial clinical trials in the US with ReN001.
A paper describing the Company's original pre-clinical efficacy data with ReN001
has been accepted for publication in the Journal of Experimental Neurology and
will appear online shortly. The paper will also form part of a special edition
of the Journal on stem cells and ischaemic brain disease that is due to appear
in print in May 2006. In the paper, ReNeuron scientists demonstrate the unique
biological characteristics of ReN001 cells and their ability to reverse chronic
sensori-motor deficits in validated rodent models of stroke after injection into
the brain.
A separate paper written by the Chairman of ReNeuron's Clinical Advisory Board,
Professor Sid Gilman, is due to appear in the same special issue of the Journal,
and has already been published on-line. Professor Gilman is the William J
Herdman Professor of Neurology at the University of Michigan. In his paper,
Professor Gilman describes time course factors and current treatment options
available or in development for stroke patients as they move from the acute to
sub-acute and chronic phases of their condition. The current lack of treatment
options for patients left with permanent disabilities is highlighted, the
sub-group ReNeuron is targeting with its ReN001 stem cell therapy and which
accounts for approximately one half of all stroke survivors.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'The results of these follow-on studies are highly significant and will form an
important part of our IND data package for ReN001. They further demonstrate the
capability of our c-mycERTAM platform technology to produce stem cell lines that
are stable, capable of rapid and efficient scale-up, and repeatedly efficacious
in validated pre-clinical models of major disease conditions.'
1. Current Good Manufacturing Practice
2. Investigational New Drug
3. US Food and Drug Administration
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: 01483 302 560
John Sinden, Chief Scientific Officer
Financial Dynamics
David Yates Tel: 020 7831 3113
Sarah Macleod
Notes to Editors
About ReNeuron Group plc
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company is
applying its novel stem cell platform technologies in the development of
ground-breaking stem cell therapies to serve significant and unmet or poorly-met
clinical needs.
ReNeuron has used its c-mycERTAM technology to generate genetically stable
neural stem cell lines. This technology platform has multi-national patent
protection and is fully regulated by means of a chemically-induced safety
switch. Cell growth can therefore be completely arrested prior to in vivo
implantation.
The Company's lead stem cell therapy, ReN001 for chronic stroke disability, is
in late pre-clinical development. The Company plans to file for approval to
commence initial clinical trials in stroke later this year, with trials
commencing as soon as possible thereafter.
The Company has also generated pre-clinical efficacy data with its ReN005 stem
cell therapy for Huntington's disease, a rare, genetic and fatal
neurodegenerative disorder which affects around 1 in 100,000 people. This
programme is in pre-clinical development.
In addition to its stroke and Huntington's disease programmes, ReNeuron is
developing stem cell therapies for Parkinson's disease, Type 1 diabetes and
diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic
areas - its ReNcell range of cell lines for use in drug discovery applications
in the pharmaceutical industry.
The Company successfully completed its flotation on the London AIM market in
August 2005, raising £9.5million before expenses. At flotation, the Company
also issued warrants which, if exercised, will raise a further £5.7m for the
Company by February 2007. ReNeuron's shares are traded under the symbol RENE.L,
and its warrants are traded under the symbol RENW.L.
Further information on ReNeuron and its products can be found at
www.reneuron.com.
This announcement contains forward-looking statements with respect to the
financial condition, results of operations and business achievements/performance
of ReNeuron and certain of the plans and objectives of management of ReNeuron
with respect thereto. These statements may generally, but not always, be
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'believes' or similar expressions. This announcement also contains
forward-looking statements attributed to certain third parties relating to their
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nature, forward-looking statements involve risk and uncertainty because they
reflect ReNeuron's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of factors could cause
ReNeuron's actual financial condition, results of operations and business
achievements/performance to differ materially from the estimates made or implied
in such forward-looking statements and, accordingly, reliance should not be
placed on such statements.
The terms 'ReNeuron' or 'the Company' refer to ReNeuron Group plc and its
subsidiary undertakings.
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