ReNeuron Regulatory Update
Guildford, UK, 1 February 2008:ReNeuron Group plc (LSE: RENE.L) today provides an update on progress with its Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to commence initial clinical trials in the US with its ReN001 stem cell therapy for stroke.
On 3 January 2008, the Company announced that it had been notified by the FDA that the above IND remained on clinical hold, with a small number of further hold issues requiring resolution. In the announcement, the Company stated its intention to meet with the FDA to discuss and agree an approach to resolving these remaining issues.
The Company has since requested a Type A, face-to-face meeting with the FDA, who have now confirmed that a meeting has been scheduled for 14 February. A Type A meeting is a recognised regulatory review meeting between the FDA and the applicant. One of the principal purposes of such a meeting is to address the issues that have resulted in a clinical hold and clarify the necessary steps to enable the therapeutic development programme in question to proceed.
The Company will make further announcements concerning the outcome of the Type A meeting when the formal minutes of the meeting become available, usually within 30 days of the meeting date.
Michael Hunt, Chief Executive Officer of ReNeuron, said: "We are grateful to the FDA for allowing us the opportunity to meet with them in the near term to clarify and resolve the remaining clinical hold issues regarding our ReN001 stroke therapy. In the meantime, and as mentioned in earlier announcements, we continue our preparations for the clinical phase of development of ReN001."
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 c-mycER 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 statements
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