ReNeuron Group plc
12 January 2007
Regulatory Update
Guildford, UK, 12 January 2007: ReNeuron Group plc (LSE: RENE) today provides a
further update regarding its recently filed Investigational New Drug (IND)
application to commence a Phase I clinical study for its ReN001 stem cell
therapy for stroke.
The Company announced on 9 January that the US Food and Drug Administration
(FDA) had placed the proposed clinical study for ReN001 on hold. A telephone
conference call with the FDA to discuss the application has subsequently taken
place, during which the FDA outlined its questions and requests for further
information regarding the IND application. The Company expects the FDA to
confirm these comments in writing within the next few days.
The points raised during the initial teleconference were largely as expected and
are readily addressable. Indeed, the Company believes that the additional
pre-clinical studies it is currently undertaking may answer the main points
raised by the FDA during the call. It is noteworthy that no substantial issues
were raised during the call that had not been covered in previous dialogue with
the FDA.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'We appreciate the diligence with which the FDA are reviewing our IND
application for ReN001, and for providing the Company with the opportunity to
engage in dialogue at this early stage in the approval process. We will be
continuing our dialogue with the FDA as we work towards providing the additional
information required. On this basis, we are confident that approval to commence
human clinical studies with ReN001 will be granted.'
Enquiries:
ReNeuron
Michael Hunt, CEO Tel: 44 (0)1483 302 560
Financial Dynamics
David Yates Tel: 44 (0)20 7831 3113
Nicola Daley
Notes to Editors
ReNeuron is a leading, UK-based adult 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.
ReNeuron has used its c-mycER(TAM) 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.
ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem cell
therapy for Huntington's disease, a genetic and fatal neurodegenerative disorder
that affects around 1 in 10,000 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(TM) range of cell lines for use in research and in drug
discovery applications in the pharmaceutical industry. ReNeuron's ReNcell(TM)
CX and ReNcell(TM) 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.
The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement refer
to ReNeuron Group plc and/or its subsidiary undertakings, depending on the
context.
This information is provided by RNS
The company news service from the London Stock Exchange
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