ReNeuron Group plc
06 September 2007
ReNeuron gives AGM update on its ReN001 stem cell therapy for stroke
Guildford, UK, 6 September 2007: ReNeuron Group plc (LSE: RENE) today announces
an update on progress with its ReN001 stem cell therapy for stroke, ahead of its
2007 Annual General Meeting.
In June, the Company stated in its preliminary full year results statement that
it was working to conclude a number of pre-clinical studies to provide further
data in support of its Interventional New Drug (IND) application to the US Food
and Drug Administration (FDA) to commence initial clinical trials with ReN001 in
the US. The most important of these is a study examining the long-term safety
profile of ReN001 in a specialised pre-clinical model of stroke.
This study has now reached its end-point, and, subject to completion of data
analysis, no significant or unusual adverse safety effects have been observed in
either control or treatment groups. The Company is encouraged by the results
both from this study and from the other studies undertaken in support of the IND
application. Based on these results, the Company confirms that it remains on
track to submit the required IND data package to the FDA in the final quarter of
2007.
The AGM will take place today at 10.00am at the offices of Morrison & Foerster
MNP, City Point, One Ropemaker Street, London, EC2Y 9AW.
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer
Europe
David Yates Tel: +44 (0) 20 7831 3113
Claire Rowell
US
Robert Stanislaro Tel : +1 212 850 5657
About ReNeuron
ReNeuron is a leading, UK-based stem cell therapy business. It 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. The
Company operates from laboratories in Surrey, UK and Los Angeles, California,
USA.
ReNeuron has used its c-mycER 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.
ReNeuron has filed for approval to commence initial clinical studies in the US
with its lead ReN001 stem cell therapy for chronic stroke disability. This
represents the world's first such filing concerning a neural stem cell treatment
for a major neurological disorder. There are an estimated 50 million stroke
survivors worldwide, approximately one half of which are left with permanent
disabilities. The annual health and social costs of caring for these patients
is estimated to be in excess of £5 billion in the UK and in excess of US$50
billion in the US.
In addition to its stroke programme, ReNeuron is developing stem cell therapies
for Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases of
the retina. The Company recently announced the acquisition of the business
assets of AmCyte Inc. in the US, bringing clinically-tested cell encapsulation
technology to ReNeuron's ReN002 diabetes programme.
ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -
its ReNcell(R) range of cell lines for use in research and in drug discovery
applications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX and
ReNcell(R)VM neural cell lines are marketed worldwide under license by Millipore
Corporation.
ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.
Further information on ReNeuron and its products can be found at
www.reneuron.com.
Data sources: UK Stroke Association; American Stroke Association.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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