Re: Clinical Investigator
ReNeuron Group plc
23 August 2006
ReNeuron appoints Principal Investigator for Phase l clinical study with its
ReN001 stem cell therapy for stroke
Guildford, UK, 23 August 2006: ReNeuron Group plc (LSE: RENE) today announces
that it has appointed Professor Douglas Kondziolka MD, MSc, FRCS, FACS as
Principal Investigator for the Phase l clinical study with its ReN001 stem cell
therapy for disabled stroke patients. This appointment represents a further
step in ReNeuron's preparations for the clinical phase of its development
programme for ReN001. The Company intends to file an Investigational New Drug
(IND) application for ReN001 with the US Food and Drug Administration (FDA)
before the end of 2006. Approval of this application will open the way to
commencement of a Phase I clinical study in the US, placing ReN001 at the
forefront of clinical-stage neural stem cell treatments for major neurological
conditions.
Professor Kondziolka is the Peter J. Jannetta Professor and Vice-Chairman of
Neurological Surgery, University of Pittsburgh. He is an eminent neurosurgeon
and a leading expert in the delivery of cell therapy treatments to stroke
patients. He has pioneered a number of neurological procedures in this field as
well as developing some of the specialised equipment required to deliver cells
to defined locations within the patient's brain.
Professor Kondziolka works with an experienced clinical team at the University
of Pittsburgh Medical Center (UPMC), the site chosen by ReNeuron for the Phase I
clinical study with ReN001. This centre also works closely with staff at the
nearby Immunologic Monitoring and Cellular Products Laboratory at the Hillman
Cancer Center, UPMC, where suspensions of ReNeuron's ReN001 stem cells will be
prepared locally for use in the studies. This is an FDA-approved facility
operating to Good Manufacturing Practice (GMP) standards.
As a consequence of his appointment as Principal Investigator, Professor
Kondziolka will relinquish his responsibilities as a member of ReNeuron's
Clinical Advisory Board.
Commenting on his appointment, Professor Kondziolka said:
'Stem cell therapy holds tremendous promise for patients with disabling
neurological diseases. I am excited by the potential of ReNeuron's ReN001
treatment for stroke, and I look forward to continued participation in the
development of this therapy when it enters the clinical phase.'
Michael Hunt, Chief Executive Officer of ReNeuron, said:
'We are delighted that Dr Kondziolka has agreed to lead our ReN001 Phase l
clinical study in stroke. His credentials in the field are outstanding and,
when approved, the early clinical phase of our ReN001 programme will be in safe
hands. This study will represent the first time that stem cells produced using
ReNeuron's proprietary c-mycERTAM expansion technology will have been used to
treat a patient. We greatly look forward to that milestone event in the
Company's history.'
Enquiries:
ReNeuron
Michael Hunt, CEO Tel: 44 (0)1483 302 560
John Sinden, CSO
Financial Dynamics
David Yates Tel: 44 (0)20 7831 3113
Sarah Macleod
Notes to Editors
ReNeuron is a leading, UK-based adult stem cell therapy business. The Group 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 means of a chemically-induced safety
switch. Cell growth can therefore be completely arrested prior to in vivo
implantation.
The Group's lead stem cell therapy, ReN001 for chronic stroke disability, is in
late pre-clinical development. Subject to successful completion of pre-clinical
testing, the Company plans to file for approval to commence a Phase I clinical
study in stroke by the end of 2006, with the study commencing as soon as
possible thereafter.
The Group has also generated pre-clinical efficacy data with its ReN005 stem
cell therapy for Huntington's disease, a rare, 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.
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.
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