RENE.L Regulatory News (RENE)

8 Mar 2006 07:32

ReNeuron Group plc08 March 2006 ReNeuron announces successful completion of cell banking with ReN001 stem cell therapy for stroke Guildford, UK, 8 March 2006: ReNeuron Group plc (LSE: RENE.L) today announcesthat it has successfully completed the scale-up and cell banking of its leadReN001 stem cell product for stroke. Master and Working cell banks have beenmanufactured to full Good Manufacturing Practice (GMP) standard, having beenfully tested for purity, sterility and stability. The banking and testingprocess took place at a contract manufacturer in the UK. Importantly, these cell banks contain the vials of ReN001 cells from which allfuture clinical and in-market product will eventually be grown. This gives theCompany the potential to progress its ReN001 stroke therapy to the clinic andbeyond without the need to re-derive ReN001 cells from source material at anystage in the future, thereby reducing risk, cost and time from the developmentpathway for this product. Michael Hunt, Chief Executive Officer of ReNeuron, said: "Completion of cell banking represents a further key milestone for our ReN001stem cell therapy for stroke. We have now shown that our proprietary c-mycERTAMtechnology has the ability to scale up human stem cells into awell-characterised, consistent and stable product for wide-scale clinical use.We believe that this, together with our recently announced repeat pre-clinicalefficacy data in stroke, places ReNeuron in a unique competitive position withrespect to its ReN001 programme." Enquiries: ReNeuron Michael Hunt, Chief Executive Officer Tel: 44 (0)1483 302 560John Sinden, Chief Scientific Officer Financial Dynamics David Yates Tel: 44 (0)20 7831 3113Sarah Macleod Notes to Editors About ReNeuron Group plc ReNeuron is a leading, UK-based adult stem cell therapy business. The Companyis applying 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-mycERTAM 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. The Company's lead stem cell therapy, ReN001 for chronic stroke disability, isin late pre-clinical development. Subject to successful completion ofpre-clinical testing, the Company plans to file for approval to commence initialclinical trials in stroke later this year, with trials commencing as soon aspossible thereafter. The Company has also generated pre-clinical efficacy data with its ReN005 stemcell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder which affects around 1 in 100,000 people. Thisprogramme is in pre-clinical development. 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 range of cell lines for use in drug discovery applicationsin the pharmaceutical industry. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L,and its warrants are traded under the symbol RENW.L. Further information on ReNeuron and its products can be found atwww.reneuron.com. 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" or "the Company" refer to ReNeuron Group plc and itssubsidiary undertakings. This information is provided by RNS The company news service from the London Stock Exchange