Files IND Application
ReNeuron Group plc
06 December 2006
ReNeuron files IND application to commence human clinical studies with ReN001
stem cell therapy for stroke
First such application to use neural (brain) stem cells to treat a major
neurological condition
Guildford, UK, 6 December 2006: ReNeuron Group plc (LSE: RENE.L) today
announces the filing of its first Investigational New Drug (IND) application
with the US Food and Drug Administration (FDA) to commence initial clinical
studies in the US with ReN001, its stem cell therapy for stroke.
This filing is a key milestone in ReNeuron's history and, the Company believes,
the world's first such application concerning a neural stem cell treatment for a
major neurological disorder. Stroke is the single largest cause of adult
disability in the developed world. Over 130,000 people suffer a stroke each
year in the UK, and over 700,000 people in the US.
ReNeuron's ReN001 stem cell therapy seeks to treat those patients who have
suffered a stroke and have been left disabled by it. These patients constitute
approximately one third of the total stroke patient population. There are
currently no approved treatments available to address the causes of their
disability. Existing treatments for stroke in the chronic phase are primarily
focused on the prevention of recurrent strokes. The annual health and social
costs of caring for disabled stroke patients is estimated to be in excess of £5
billion in the UK, with stroke patients occupying 25 per cent of long term
hospital beds. In the US, the annual direct and indirect costs of stroke are
estimated to be in excess of US$50 billion.
Following approval of the IND, the initial clinical study will be conducted
under the direction of Professor Douglas Kondziolka MD, MSc, FRCS, FACS at the
University of Pittsburgh Medical Centre. The initial Phase I study with ReN001
will be an open label study, with two dose levels, in disabled stroke patients.
The primary objective of the study will be to monitor the safety profile of the
treatment. Preliminary efficacy measures will also be recorded, however, to
provide an indication of therapeutic potential ahead of further efficacy studies
in a larger cohort of patients once the safety of the ReN001 therapy has been
confirmed.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'Today's announcement is a significant milestone for ReNeuron and for the wider
stem cell field. We have been greatly encouraged by the pre-clinical data
generated in support of the IND application, and we now look forward to taking
ReN001 into its clinical phase. The IND filing represents the first step
towards determining the safety and efficacy of our ReN001 therapy in man, in
order to ultimately bring this treatment to the many patients who could benefit
from it. Importantly, approval of this IND will also provide validation for our
proprietary c-mycER(TAM) cell expansion technology, thereby adding impetus to our
other therapeutic programmes to which this technology has been applied.'
Professor Kondziolka at the University of Pittsburgh Medical Center, commented:
'Our team has participated in the design of ReNeuron's first clinical study and
we are excited about the potential this research offers in the field of brain
repair. This study seeks to address the immense problem of disability following
stroke, for which there are few treatment options.'
Enquiries:
Michael Hunt, Chief Executive Officer
John Sinden, Chief Scientific Officer
ReNeuron Group plc +44 (0)1483 302560
David Yates, Nicola Daley
Financial Dynamics - Europe +44 (0)20 7831 3113
Jonathan Birt, John Capodanno
Financial Dynamics - US +1 (212) 850 5755
Note 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.
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 range of cell lines for use in drug discovery applications
in the pharmaceutical industry.
ReNeuron's shares are traded on the London AIM market under the symbol RENE.L,
and its warrants are traded under the symbol RENW.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.
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