Research Update
ReNeuron Group plc
18 November 2005
ReNeuron announces first results from key pre-clinical safety studies with its
lead ReN001 stem cell line for stroke
Guildford, UK, 18 November 2005: ReNeuron Group plc (LSE: RENE.L) today
announced that it has generated provisional pre-clinical data indicating that
its lead ReN001 cell line for stroke does not form tumours following
implantation. The ability to demonstrate a lack of tumorigenicity in vivo is
one of the principal safety hurdles that must be overcome before regulatory
authorities will allow commencement of human clinical trials using stem
cell-based therapies.
ReNeuron's data were generated in two validated rodent models, part of the
package of studies making up the Company's overall pre-clinical development
programme for its ReN001 stroke therapy ahead of initial human clinical trials.
A key safety feature of the Company's platform c-mycERTAM technology, from
which its ReN001 therapy was derived, is its ability to fully control and arrest
cell proliferation prior to implantation of those cells into the brain.
One study has reported in full, with nothing abnormal reported. In particular,
there was no evidence of tumour formation. A second study in a more sensitive
model is also well advanced and, to date, nothing abnormal has been seen or
reported in this second study.
Commenting on the announcement, John Sinden, CSO of ReNeuron, said:
'We are greatly encouraged by these provisional safety data read-outs. They
represent an important step forward in terms of demonstrating the ability of our
c-mycERTAM platform technology to deliver a safe and efficacious stem cell
therapy for a large-scale indication, in this case our ReN001 therapy for
stroke. The findings are indicative of the power of c-mycERTAM to fully control
the proliferative capacity of stem cells, a vital safety characteristic of the
technology from a regulatory perspective.'
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302 560
John Sinden, Chief Scientific Officer
Financial Dynamics - Europe
David Yates, Sarah MacLeod Tel: +44 (0) 20 7831 3113
Financial Dynamics - US
Jonathan Birt, John Capodanno Tel: +1 (212) 850 5755
Notes to Editors
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 way 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 by mid-2006, with trials commencing
as soon as possible thereafter.
In addition to its ReN001 stroke programme, ReNeuron has programmes to develop
stem cell therapies to address Huntington's disease, 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
identified by the use of words such as 'should', 'expects', 'estimates',
'believes' or similar expressions. This announcement also contains
forward-looking statements attributed to certain third parties relating to their
estimates regarding the growth of markets and demand for products. By their
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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