Research Update
ReNeuron Group plc
22 September 2005
PRESS RELEASE
ReNeuron Group plc holds key meeting with the FDA regarding its ReN001 stem cell
therapy for stroke
Guildford, UK, 22 September 2005: ReNeuron Group plc (LSE: RENE.L) today
announced that it has held a formal pre-IND(1) meeting with the CBER(2)
component of the US Food & Drug Administration (FDA) regarding its lead ReN001
stem cell therapy to treat chronic disability after stroke.
The Company attended the meeting in July with reviewers from CBER, the group
within the FDA responsible for the evaluation of biologics, including cell and
gene therapies. The pre-IND meeting followed informal discussions with members
of CBER concerning the ReN001 programme, and the subsequent submission of a
pre-IND dossier by the Company.
The Company has now received and reviewed the official minutes of the pre-IND
meeting. As a result, ReNeuron is maintaining its pre-clinical development
timelines for its ReN001 stroke programme and, subject to successful completion
of pre-clinical testing, remains confident of achieving its goal of filing an
IND application (to commence initial clinical trials) with the FDA by mid-2006.
Whilst working to meet the FDA's pre-clinical requirements with respect to the
ReN001 programme, ReNeuron is also meeting with the equivalent UK and European
regulators in order to determine the regulatory requirements for ReN001 in
European markets.
Commenting on the announcement, Michael Hunt, CEO of ReNeuron, said:
'ReNeuron's ReN001 stem cell therapy for stroke is a pioneering development
programme, and therefore one where we believe collaboration between ReNeuron and
the regulatory authorities is critical in defining the safety and performance
criteria for the therapy. We are grateful to the CBER team for their
constructive comments and assistance in helping the Company to define the most
appropriate development strategy for ReN001, and we look forward to further
positive interaction with CBER and the regulatory authorities in Europe as
ReN001 progresses towards the clinic.'
(1)Investigational New Drug
(2)Center for Biologics Evaluation and Research
Enquiries:
ReNeuron
Michael Hunt, CEO Tel: 01483 302 560
John Sinden, CSO
Financial Dynamics
David Yates Tel: 020 7831 3113
Sarah Macleod
Notes to Editors
ReNeuron is a leading, UK-based adult stem cell therapy business. The Company 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-mycERTAM technology to generate genetically stable
neural stem cell lines. This technology platform has multi-national patent
protection and is fully regulated by way of a chemically-induced safety switch.
Cell growth can therefore be completely arrested prior to in vivo implantation.
The Company's lead stem cell therapy, ReN001 for chronic stroke disability, is
in late pre-clinical development. The Company plans to file for approval to
commence initial clinical trials in stroke by mid-2006, with trials commencing
as soon as possible thereafter. If this application is successful, the Company
believes that its ReN001 programme would be the world's first clinical-stage
neural stem cell therapy for stroke patients.
In addition to its ReN001 stroke programme, ReNeuron has programmes to develop
stem cell therapies to address Huntington's disease, Parkinson's disease, Type 1
diabetes and diseases of the retina.
ReNeuron has also leveraged its stem cell technologies into non-therapeutic
areas such as drug discovery - its ReNcell product.
The Company successfully completed its flotation on the London AIM market in
August 2005, raising £9.5million before expenses. At flotation, the Company
also issued warrants which, if exercised, will raise a further £5.7m for the
Company by February 2007. ReNeuron's shares are traded under the symbol RENE.L,
and its warrants are traded under the symbol RENW.L.
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' or 'the Company' refer to ReNeuron Group plc and its
subsidiary undertakings.
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