ReNeuron Group plc
01 February 2008
Regulatory update
Guildford, UK, 1 February 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 January 2008, the Company announced that it had been notified by the FDA
that the above IND remained on clinical hold, with a small number of further
hold issues requiring resolution. In the announcement, the Company stated its
intention to meet with the FDA to discuss and agree an approach to resolving
these remaining issues.
The Company has since requested a Type A, face-to-face meeting with the FDA, who
have now confirmed that a meeting has been scheduled for 14 February. A Type A
meeting is a recognised regulatory review meeting between the FDA and the
applicant. One of the principal purposes of such a meeting is to address the
issues that have resulted in a clinical hold and clarify the necessary steps to
enable the therapeutic development programme in question to proceed.
The Company will make further announcements concerning the outcome of the Type A
meeting when the formal minutes of the meeting become available, usually within
30 days of the meeting date.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'We are grateful to the FDA for allowing us the opportunity to meet with them
in the near term to clarify and resolve the remaining clinical hold issues
regarding our ReN001 stroke therapy. In the meantime, and as mentioned in
earlier announcements, we continue our preparations for the clinical phase of
development of ReN001.'
Enquiries:
ReNeuron
Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560
Financial Dynamics
Dr John Sinden, Chief Scientific Officer
Europe
David Yates Tel: +44 (0) 20 7831 3113
Lara Mott
US
Robert Stanislaro Tel : +1 212 850 5657
Collins Stewart
Tim Mickley Tel: +44 (0) 20 7523 8000
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. 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 acquired 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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