RENE.L Regulatory News (RENE)

6 Sep 2007 07:00

ReNeuron Group plc06 September 2007 ReNeuron gives AGM update on its ReN001 stem cell therapy for stroke Guildford, UK, 6 September 2007: ReNeuron Group plc (LSE: RENE) today announcesan update on progress with its ReN001 stem cell therapy for stroke, ahead of its2007 Annual General Meeting. In June, the Company stated in its preliminary full year results statement thatit was working to conclude a number of pre-clinical studies to provide furtherdata in support of its Interventional New Drug (IND) application to the US Foodand Drug Administration (FDA) to commence initial clinical trials with ReN001 inthe US. The most important of these is a study examining the long-term safetyprofile of ReN001 in a specialised pre-clinical model of stroke. This study has now reached its end-point, and, subject to completion of dataanalysis, no significant or unusual adverse safety effects have been observed ineither control or treatment groups. The Company is encouraged by the resultsboth from this study and from the other studies undertaken in support of the INDapplication. Based on these results, the Company confirms that it remains ontrack to submit the required IND data package to the FDA in the final quarter of2007. The AGM will take place today at 10.00am at the offices of Morrison & FoersterMNP, City Point, One Ropemaker Street, London, EC2Y 9AW. Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560Dr John Sinden, Chief Scientific Officer EuropeDavid Yates Tel: +44 (0) 20 7831 3113Claire RowellUSRobert Stanislaro Tel : +1 212 850 5657 About ReNeuron ReNeuron is a leading, UK-based stem cell therapy business. It is applying itsnovel stem cell platform technologies in the development of ground-breaking stemcell therapies to serve significant and unmet or poorly-met clinical needs. TheCompany operates from laboratories in Surrey, UK and Los Angeles, California,USA. ReNeuron has used its c-mycER technology to generate genetically stable neuralstem cell lines. This technology platform has multi-national patent protectionand is fully regulated by means of a chemically-induced safety switch. Cellgrowth can therefore be completely arrested prior to in vivo implantation. ReNeuron has filed for approval to commence initial clinical studies in the USwith its lead ReN001 stem cell therapy for chronic stroke disability. Thisrepresents the world's first such filing concerning a neural stem cell treatmentfor a major neurological disorder. There are an estimated 50 million strokesurvivors worldwide, approximately one half of which are left with permanentdisabilities. The annual health and social costs of caring for these patientsis estimated to be in excess of £5 billion in the UK and in excess of US$50billion in the US. In addition to its stroke programme, ReNeuron is developing stem cell therapiesfor Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases ofthe retina. The Company recently announced the acquisition of the businessassets of AmCyte Inc. in the US, bringing clinically-tested cell encapsulationtechnology to ReNeuron's ReN002 diabetes programme. ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -its ReNcell(R) range of cell lines for use in research and in drug discoveryapplications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX andReNcell(R)VM neural cell lines are marketed worldwide under license by MilliporeCorporation. 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 atwww.reneuron.com. Data sources: UK Stroke Association; American Stroke Association. This announcement contains forward-looking statements with respect to thefinancial condition, results of operations and business achievements/performanceof ReNeuron and certain of the plans and objectives of management of ReNeuronwith respect thereto. These statements may generally, but not always, beidentified by the use of words such as "should", "expects", "estimates","believes" or similar expressions. This announcement also containsforward-looking statements attributed to certain third parties relating to theirestimates regarding the growth of markets and demand for products. By theirnature, forward-looking statements involve risk and uncertainty because theyreflect ReNeuron's current expectations and assumptions as to future events andcircumstances that may not prove accurate. A number of factors could causeReNeuron's actual financial condition, results of operations and businessachievements/performance to differ materially from the estimates made or impliedin such forward-looking statements and, accordingly, reliance should not beplaced on such statements. This information is provided by RNS The company news service from the London Stock Exchange