RENE.L Regulatory News (RENE)

3 Jan 2008 13:28

ReNeuron Group plc03 January 2008 PRESS RELEASE Regulatory update Guildford, UK, 3 January 2008: ReNeuron Group plc (LSE: RENE.L) today providesan update on progress with its Investigational New Drug (IND) application to theUS Food and Drug Administration (FDA) to commence initial clinical trials in theUS with its ReN001 stem cell therapy for stroke. On 3 December 2007, the Company announced that it had submitted its responses tothe requests made by the FDA in respect of the original IND application. TheCompany has subsequently been notified that the IND currently remains onclinical hold. Whilst most of the substantive issues raised by the FDA in theoriginal IND hold letter have been satisfactorily addressed in the amended INDpackage, there are a small number of further hold issues that remain to beresolved. The Company intends to meet with the FDA shortly to discuss and agreean approach to resolving these remaining issues in a timely fashion. Furtherannouncements will be made by the Company in due course. In the meantime, the Company is continuing its preparations for the clinicalphase of development of its ReN001 therapy. As mentioned in the Company's recentinterim results statement, these preparations include continuing dialogue withregulatory authorities in other key territories such as the UK, with a view tofurther clinical trial applications in these territories in due course. Michael Hunt, Chief Executive Officer of ReNeuron, said: "We look forward to continuing our dialogue with the FDA and other regulatoryauthorities regarding ReN001. Given the ground-breaking nature of this therapyand the lack of clinical precedent, it is not surprising that the FDA isadopting a cautious and thorough approach in its review of the IND data package.That said, and based on the proof-of-concept, safety and product manufacturingdata package that we have and are continuing to build for ReN001, we remainconfident that this therapy can be taken into the clinic this year." Enquiries: ReNeuron Michael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560Dr John Sinden, Chief Scientific Officer Financial Dynamics EuropeDavid Yates Tel: +44 (0) 20 7831 3113Lara Mott USRobert Stanislaro Tel : +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