ReNeuron 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."
Notes to editors
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 Â£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 â€“ its ReNcellÂ® range of cell lines for use in research and in drug discovery applications in the pharmaceutical industry. ReNeuron's ReNcellÂ®CX and ReNcellÂ®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.
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
Tel: +44 (0) 1483 302560
Tel:+44 (0) 20 7831 3113
Tel: +1 212 850 5657
Tel: +44 (0) 20 7523 8000
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 statement.