RENE.L Regulatory News (RENE)

12 Jan 2007 10:02

ReNeuron Group plc12 January 2007 Regulatory Update Guildford, UK, 12 January 2007: ReNeuron Group plc (LSE: RENE) today provides afurther update regarding its recently filed Investigational New Drug (IND)application to commence a Phase I clinical study for its ReN001 stem celltherapy 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 telephoneconference call with the FDA to discuss the application has subsequently takenplace, during which the FDA outlined its questions and requests for furtherinformation regarding the IND application. The Company expects the FDA toconfirm these comments in writing within the next few days. The points raised during the initial teleconference were largely as expected andare readily addressable. Indeed, the Company believes that the additionalpre-clinical studies it is currently undertaking may answer the main pointsraised by the FDA during the call. It is noteworthy that no substantial issueswere raised during the call that had not been covered in previous dialogue withthe FDA. Michael Hunt, Chief Executive Officer of ReNeuron, said: "We appreciate the diligence with which the FDA are reviewing our INDapplication for ReN001, and for providing the Company with the opportunity toengage in dialogue at this early stage in the approval process. We will becontinuing our dialogue with the FDA as we work towards providing the additionalinformation required. On this basis, we are confident that approval to commencehuman clinical studies with ReN001 will be granted." Enquiries: ReNeuronMichael Hunt, CEO Tel: 44 (0)1483 302 560 Financial DynamicsDavid Yates Tel: 44 (0)20 7831 3113Nicola Daley Notes to Editors ReNeuron is a leading, UK-based adult stem cell therapy business. It isapplying its novel stem cell platform technologies in the development ofground-breaking stem cell therapies to serve significant and unmet or poorly-metclinical needs. ReNeuron has used its c-mycER(TAM) technology to generate genetically stableneural stem cell lines. This technology platform has multi-national patentprotection and is fully regulated by means of a chemically-induced safetyswitch. Cell growth can therefore be completely arrested prior to in vivoimplantation. 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. ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem celltherapy for Huntington's disease, a genetic and fatal neurodegenerative disorderthat affects around 1 in 10,000 people. This programme is in pre-clinicaldevelopment. In addition to its stroke and Huntington's disease programmes, ReNeuron isdeveloping stem cell therapies for Parkinson's disease, Type 1 diabetes anddiseases 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 Exchange