RENE.L Regulatory News (RENE)

18 Nov 2005 07:00

ReNeuron Group plc18 November 2005 ReNeuron announces first results from key pre-clinical safety studies with its lead ReN001 stem cell line for stroke Guildford, UK, 18 November 2005: ReNeuron Group plc (LSE: RENE.L) todayannounced that it has generated provisional pre-clinical data indicating thatits lead ReN001 cell line for stroke does not form tumours followingimplantation. The ability to demonstrate a lack of tumorigenicity in vivo isone of the principal safety hurdles that must be overcome before regulatoryauthorities will allow commencement of human clinical trials using stemcell-based therapies. ReNeuron's data were generated in two validated rodent models, part of thepackage of studies making up the Company's overall pre-clinical developmentprogramme for its ReN001 stroke therapy ahead of initial human clinical trials.A key safety feature of the Company's platform c-mycERTAM technology, fromwhich its ReN001 therapy was derived, is its ability to fully control and arrestcell proliferation prior to implantation of those cells into the brain. One study has reported in full, with nothing abnormal reported. In particular,there was no evidence of tumour formation. A second study in a more sensitivemodel is also well advanced and, to date, nothing abnormal has been seen orreported in this second study. Commenting on the announcement, John Sinden, CSO of ReNeuron, said: "We are greatly encouraged by these provisional safety data read-outs. Theyrepresent an important step forward in terms of demonstrating the ability of ourc-mycERTAM platform technology to deliver a safe and efficacious stem celltherapy for a large-scale indication, in this case our ReN001 therapy forstroke. The findings are indicative of the power of c-mycERTAM to fully controlthe proliferative capacity of stem cells, a vital safety characteristic of thetechnology from a regulatory perspective." Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302 560John Sinden, Chief Scientific Officer Financial Dynamics - EuropeDavid Yates, Sarah MacLeod Tel: +44 (0) 20 7831 3113 Financial Dynamics - USJonathan Birt, John Capodanno Tel: +1 (212) 850 5755 Notes to Editors ReNeuron is a leading, UK-based adult stem cell therapy business. The Company 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 way of a chemically-induced safety switch.Cell growth can therefore be completely arrested prior to in vivo implantation. The Company's lead stem cell therapy, ReN001 for chronic stroke disability, isin late pre-clinical development. The Company plans to file for approval tocommence initial clinical trials in stroke by mid-2006, with trials commencingas soon as possible thereafter. In addition to its ReN001 stroke programme, ReNeuron has programmes to developstem cell therapies to address Huntington's disease, Parkinson's disease, Type 1diabetes and diseases 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. The Company successfully completed its flotation on the London AIM market inAugust 2005, raising £9.5million before expenses. At flotation, the Companyalso issued warrants which, if exercised, will raise a further £5.7m for theCompany by February 2007. ReNeuron's shares are traded 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