Regulatory Update
ReNeuron Group plc
19 March 2008
PRESS RELEASE
Regulatory update
Guildford, UK, 19 March 2008: ReNeuron Group plc (LSE: RENE.L) today provides a
further update on progress with its regulatory strategy for its ReN001 stem cell
therapy for stroke.
On 14 February, the Company met with the US Food and Drug Administration (FDA)
to discuss and clarify the necessary steps to enable approval of the Company's
Investigational New Drug (IND) application to commence initial clinical trials
in the US with ReN001.
The formal minutes from that meeting have been received and reviewed by the
Company, detailing the further information and pre-clinical data to be provided
to enable the IND to be approved. The Company will continue to liaise closely
with the FDA to ensure its approach to the provision of this further data is
acceptable to them. The Company anticipates that several months will be
required to provide all of the data requested, depending on the final agreed
study protocols.
In the meantime, the Company is accelerating its pre-existing strategy to make
clinical trial applications for ReN001 in certain other territories beyond the
US with established and recognised regulatory frameworks. These applications are
being made based on recent positive face-to-face meetings with the regulators in
these territories, and with the support of the clinicians and hospitals
concerned. The Company will look to commence initial clinical studies in these
territories ahead of the US, should approval be gained sooner in these
territories. On this basis, the Company remains confident of gaining regulatory
approval to commence an initial clinical study with ReN001 later this year.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'During our meeting with them, the FDA expressed their clear desire to work with
us to enable initial clinical studies to commence in the US with ReN001. It is
also important to note that the wealth of pre-clinical data we have already
generated shows ReN001 to be safe and efficacious, with no adverse safety
effects arising. We continue to draw encouragement from these facts, and will
continue to work with the FDA to provide the further data they have asked for.
'That said, we now deem it prudent to accelerate the process of filing clinical
trial applications for ReN001 in certain other territories where discussions
with the relevant regulators have given us high confidence that such
applications will be treated favourably. Our principal near-term goal remains to
drive the ReN001 programme into its clinical phase in a well-regulated territory
at the earliest opportunity. We are confident of achieving that goal over the
course of 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
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 proprietary, patented cell expansion 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