ReNeuron Group plc
03 January 2008
PRESS RELEASE
Regulatory update
Guildford, UK, 3 January 2008: ReNeuron Group plc (LSE: RENE.L) today provides
an update on progress with its Investigational New Drug (IND) application to the
US Food and Drug Administration (FDA) to commence initial clinical trials in the
US with its ReN001 stem cell therapy for stroke.
On 3 December 2007, the Company announced that it had submitted its responses to
the requests made by the FDA in respect of the original IND application. The
Company has subsequently been notified that the IND currently remains on
clinical hold. Whilst most of the substantive issues raised by the FDA in the
original IND hold letter have been satisfactorily addressed in the amended IND
package, there are a small number of further hold issues that remain to be
resolved. The Company intends to meet with the FDA shortly to discuss and agree
an approach to resolving these remaining issues in a timely fashion. Further
announcements will be made by the Company in due course.
In the meantime, the Company is continuing its preparations for the clinical
phase of development of its ReN001 therapy. As mentioned in the Company's recent
interim results statement, these preparations include continuing dialogue with
regulatory authorities in other key territories such as the UK, with a view to
further clinical trial applications in these territories in due course.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'We look forward to continuing our dialogue with the FDA and other regulatory
authorities regarding ReN001. Given the ground-breaking nature of this therapy
and the lack of clinical precedent, it is not surprising that the FDA is
adopting a cautious and thorough approach in its review of the IND data package.
That said, and based on the proof-of-concept, safety and product manufacturing
data package that we have and are continuing to build for ReN001, we remain
confident that this therapy can be taken into the clinic this year.'
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer
Financial Dynamics
Europe
David Yates Tel: +44 (0) 20 7831 3113
Lara Mott
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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