Research Update
ReNeuron Group plc
21 November 2007
ReNeuron welcomes ground-breaking research on gene-based reprogramming of human
stem cells
Guildford, UK, 21 November 2007: ReNeuron Group plc (LSE: RENE.L) today welcomes
the publication of ground-breaking research into the reprogramming of adult
human stem cells undertaken by teams lead by Shinya Yamanaka and James Thomson
of, respectively, Kyoto University and the University of Wisconsin-Madison. By
the insertion of a combination of genes into somatic skin cells, the teams have
been able to reprogram the cells back to an embryonic-like state, thus
potentially avoiding the use of embryos to derive pluripotent stem cells.
One of the four genes used in the research was c-myc, a gene over-expressed in
embryonic development. ReNeuron also uses a variant of this gene to derive its
own stem cell lines for therapeutic development, and has a world-wide exclusive
license to the use of this gene in the development of neural stem cell
therapies. Crucially, ReNeuron has developed a fully controllable version of the
gene, c-mycER, by which cell growth can be completely arrested, via a
chemically-based safety switch, prior to introduction of the stem cells into the
patient.
ReNeuron has utilised this c-mycER platform cell expansion technology to convert
exciting science into commercially viable therapeutic stem cell lines. As part
of the late pre-clinical development of its lead ReN001 cell therapy for stroke,
ReNeuron has also demonstrated the safety of its technology as applied to
ReN001, in long-term pre-clinical safety studies. ReNeuron intends to shortly
submit an amended Interventional New Drug (IND) application to the US Food and
Drug Administration (FDA) to commence initial clinical trials with ReN001 in the
US.
John Sinden, Chief Scientific Officer of ReNeuron, said:
'We believe that this research breakthrough has much relevance to ReNeuron's
approach to the expansion of stable and biologically potent stem cell lines. We
regard the research as a strong scientific endorsement of the technique of
gene-based manipulation of stem cells such as that employed by ReNeuron in the
development of its own, commercially viable, stem cell therapeutics, including
our lead product, ReN001 for stroke.'
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
Tel: +44 (0) 1483 302560
Europe
David Yates
Lara Mott
Tel: +44 (0) 20 7831 3113
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
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