RENE.L Regulatory News (RENE)

21 Nov 2007 11:30

ReNeuron Group plc21 November 2007 ReNeuron welcomes ground-breaking research on gene-based reprogramming of humanstem cells Guildford, UK, 21 November 2007: ReNeuron Group plc (LSE: RENE.L) today welcomesthe publication of ground-breaking research into the reprogramming of adulthuman stem cells undertaken by teams lead by Shinya Yamanaka and James Thomsonof, respectively, Kyoto University and the University of Wisconsin-Madison. Bythe insertion of a combination of genes into somatic skin cells, the teams havebeen able to reprogram the cells back to an embryonic-like state, thuspotentially avoiding the use of embryos to derive pluripotent stem cells. One of the four genes used in the research was c-myc, a gene over-expressed inembryonic development. ReNeuron also uses a variant of this gene to derive itsown stem cell lines for therapeutic development, and has a world-wide exclusivelicense to the use of this gene in the development of neural stem celltherapies. Crucially, ReNeuron has developed a fully controllable version of thegene, c-mycER, by which cell growth can be completely arrested, via achemically-based safety switch, prior to introduction of the stem cells into thepatient. ReNeuron has utilised this c-mycER platform cell expansion technology to convertexciting science into commercially viable therapeutic stem cell lines. As partof the late pre-clinical development of its lead ReN001 cell therapy for stroke,ReNeuron has also demonstrated the safety of its technology as applied toReN001, in long-term pre-clinical safety studies. ReNeuron intends to shortlysubmit an amended Interventional New Drug (IND) application to the US Food andDrug Administration (FDA) to commence initial clinical trials with ReN001 in theUS. John Sinden, Chief Scientific Officer of ReNeuron, said: "We believe that this research breakthrough has much relevance to ReNeuron'sapproach to the expansion of stable and biologically potent stem cell lines. Weregard the research as a strong scientific endorsement of the technique ofgene-based manipulation of stem cells such as that employed by ReNeuron in thedevelopment of its own, commercially viable, stem cell therapeutics, includingour lead product, ReN001 for stroke." Enquiries: ReNeuronMichael Hunt, Chief Executive OfficerDr John Sinden, Chief Scientific OfficerTel: +44 (0) 1483 302560 EuropeDavid YatesLara MottTel: +44 (0) 20 7831 3113USRobert StanislaroTel : +1 212 850 5657 About ReNeuron 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. TheCompany operates from laboratories in Surrey, UK and Los Angeles, California,USA. 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. 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. In addition to its stroke programme, ReNeuron is developing stem cell therapiesfor Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases ofthe retina. The Company recently announced the acquisition of the businessassets of AmCyte Inc. in the US, bringing clinically-tested cell encapsulationtechnology to ReNeuron's ReN002 diabetes programme. ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -its ReNcell(R) range of cell lines for use in research and in drug discoveryapplications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX andReNcell(R)VM neural cell lines are marketed worldwide under license by MilliporeCorporation. 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 This information is provided by RNS The company news service from the London Stock Exchange