ReNeuron to Commence Phase I Study of ReN001, Stem Cell Therapy
GUILDFORD, England, Jan. 12, 2007: ReNeuron Group plc (LSE: RENE) today provides a further update regarding its recently filed Investigational New Drug (IND) application to commence a Phase I clinical study for its ReN001 stem cell therapy for stroke.
The Company announced on 9 January that the US Food and Drug Administration (FDA) had placed the proposed clinical study for ReN001 on hold. A telephone conference call with the FDA to discuss the application has subsequently taken place, during which the FDA outlined its questions and requests for further information regarding the IND application. The Company expects the FDA to confirm these comments in writing within the next few days.
The points raised during the initial teleconference were largely as expected and are readily addressable. Indeed, the Company believes that the additional pre-clinical studies it is currently undertaking may answer the main points raised by the FDA during the call. It is noteworthy that no substantial issues were raised during the call that had not been covered in previous dialogue with the FDA.
Michael Hunt, Chief Executive Officer of ReNeuron, said: "We
appreciate the diligence with which the FDA are reviewing our IND
application for ReN001, and for providing the Company with the
opportunity to engage in dialogue at this early stage in the
approval process. We will be continuing our dialogue with the FDA
as we work towards providing the additional information required.
On this basis, we are confident that approval to commence human
clinical studies with ReN001 will be granted."
Notes 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-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.
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. 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.
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 ReNcellTM range of cell lines for use in research and in drug discovery applications in the pharmaceutical industry. ReNeuron's ReNcellTM CX and ReNcellTM 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.
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.
Further information on ReNeuron and its products can be found at www.reneuron.com.
Data sources: UK Stroke Association, American Stroke Association.
Further information
ReNeuron
Michael Hunt, CEO
Tel: 44 (0)1483 302 560
Financial Dynamics
David Yates
Nicola Daley
Tel: 44 (0)20 7831 3113
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