25th Apr 2007 16:46
ReNeuron Group plc25 April 2007 ReNeuron welcomes European Parliament support for Advanced Therapies Regulation Guildford, UK, 25 April 2007: ReNeuron Group plc (LSE: RENE.L) welcomes today'svote by the European Parliament to create a regulatory framework and singleEuropean marketing authorisation for gene therapy, cell therapy and tissueengineered products. MEPs voted in favour of a compromise package of amendmentsand Parliament rejected all ethical amendments banning products derived fromhuman embryonic stem cells from the scope of the Regulation. These amendmentssignificantly increase the possibility of early adoption of the Regulation. TheRegulation will harmonise patient access to innovative treatments in Europe byremoving the hurdles created by the many differing regulatory systems across theContinent. Michael Hunt, Chief Executive Officer of ReNeuron, said: "Today's vote is very significant for ReNeuron and all those involved indeveloping advanced and innovative therapies for patients in Europe andelsewhere. A significant obstacle in ensuring access to these treatments acrossEurope has been removed, making possible the establishment of a workableregulatory system which will assess the efficacy and safety of these therapiesin a consistent manner. This can serve only to benefit the patients in need ofthese treatments as well as those working hard to provide them." Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560Dr John Sinden, Chief Scientific Officer Financial DynamicsDavid Yates Tel: +44 (0) 20 7831 3113Nicola Daley Notes to Editors 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. 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. ReNeuron has also generated pre-clinicalefficacy data with its ReN005 stem cell therapy for Huntington's disease, agenetic and fatal neurodegenerative disorder that affects around 1 in 10,000people. This programme is in pre-clinical development. In addition to itsstroke and Huntington's disease programmes, ReNeuron is developing stem celltherapies for Parkinson's disease, Type 1 diabetes and diseases of the retina. ReNeuron has also leveraged its stem cell technologies into non-therapeuticareas - its ReNcell(TM) range of cell lines for use in research and in drugdiscovery applications in the pharmaceutical industry. ReNeuron's ReNcell(TM) CX and ReNcell(TM) VM neural cell lines are marketed worldwide under license byMillipore 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 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. The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement referto ReNeuron Group plc and/or its subsidiary undertakings, depending on thecontext. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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