RENE.L Regulatory News (RENE)

29 Jun 2006 07:02

ReNeuron Group plc29 June 2006 ReNeuron to present new safety data regarding its stem cell expansion technologyand its ReN001 stem cell line for stroke Guildford, UK, 29 June 2006: ReNeuron Group plc (LSE: RENE) today announces thatit will be presenting significant new data concerning both its c-mycERTAM stemcell expansion technology and its ReN001 stem cell line for stroke at leadinginternational stem cell and neuroscience conferences. ReNeuron's c-mycERTAM expansion technology is activated by the presence of achemical safety switch, 4-hydroxy tamoxifen (4-OHT), which is added to the stemcell growth medium to initiate cell division whilst maintaining the geneticstability of the cells. Removal of 4-OHT will arrest cell division prior totransplantation of the cells. These new results show that the c-mycERTAMtransgene is highly specific to 4-OHT and will not be switched oninappropriately by other related ligands that might be present in a clinicalsetting such as the drug, tamoxifen, and naturally occurring steroids andhormones such as estradiol, progesterone and testosterone. These findings represent a significant addition to the overall safety profile ofReNeuron's c-mycERTAM technology platform in terms of its potential to generatestem cell lines appropriate for therapeutic use. The presentation of thesefindings is one of three poster presentations that ReNeuron will make at the 4thAnnual Meeting of the International Society for Stem Cell Research in Toronto,Canada on 29 June to I July 2006. Separately, ReNeuron has demonstrated that its ReN001 stem cell line for strokewill survive in pre-clinical rodent models regardless of whether ananti-inflammatory or immunosuppressant drug regimen is used in conjunction withthe transplantation of the cells. This finding further demonstrates thepotential utility of ReN001 as a cell-based therapeutic agent where theseadjunctive therapies may be required. ReNeuron is presenting these findings atthe FENS 5th Forum of European Neuroscience meeting in Vienna, Austria, on 8 -12July 2006. Commenting on the announcement, Dr John Sinden, Chief Scientific Officer ofReNeuron, said: "These new findings further illustrate the robustness and significant safetycharacteristics of our cell expansion technology and the ReN001cell linedeveloped from it. We have already developed a broad safety and efficacy datapackage for ReN001 and the c-mycERTAM cell expansion platform. These furtherfindings will serve to enhance this data package ahead of the clinical trialapplication for ReN001 in stroke which we intend to file later this year." Enquiries: ReNeuronMichael Hunt, CEO Tel: 44 (0)1483 302 560John Sinden, CSO Financial DynamicsDavid Yates Tel: 44 (0)20 7831 3113Sarah Macleod Notes to Editors ReNeuron is a leading, UK-based adult stem cell therapy business. The Group 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-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 Group's lead stem cell therapy, ReN001 for chronic stroke disability, is inlate pre-clinical development. Subject to successful completion of pre-clinicaltesting, the Company plans to file for approval to commence initial clinicaltrials in stroke by the end of 2006, with trials commencing as soon as possiblethereafter. The Group has also generated pre-clinical efficacy data with its ReN005 stemcell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder that affects around 1 in 10,000 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. This information is provided by RNS The company news service from the London Stock Exchange