ReNeuron Group plc
08 March 2006
ReNeuron announces successful completion of cell banking with ReN001 stem cell
therapy for stroke
Guildford, UK, 8 March 2006: ReNeuron Group plc (LSE: RENE.L) today announces
that it has successfully completed the scale-up and cell banking of its lead
ReN001 stem cell product for stroke. Master and Working cell banks have been
manufactured to full Good Manufacturing Practice (GMP) standard, having been
fully tested for purity, sterility and stability. The banking and testing
process took place at a contract manufacturer in the UK.
Importantly, these cell banks contain the vials of ReN001 cells from which all
future clinical and in-market product will eventually be grown. This gives the
Company the potential to progress its ReN001 stroke therapy to the clinic and
beyond without the need to re-derive ReN001 cells from source material at any
stage in the future, thereby reducing risk, cost and time from the development
pathway for this product.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'Completion of cell banking represents a further key milestone for our ReN001
stem cell therapy for stroke. We have now shown that our proprietary c-mycERTAM
technology has the ability to scale up human stem cells into a
well-characterised, consistent and stable product for wide-scale clinical use.
We believe that this, together with our recently announced repeat pre-clinical
efficacy data in stroke, places ReNeuron in a unique competitive position with
respect to its ReN001 programme.'
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: 44 (0)1483 302 560
John Sinden, Chief Scientific Officer
Financial Dynamics
David Yates Tel: 44 (0)20 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. Subject to successful completion of
pre-clinical testing, 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.
ReNeuron's shares are traded on the London AIM market 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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