RENE.L Regulatory News (RENE)

1 Feb 2008 07:01

ReNeuron Group plc01 February 2008 Regulatory update Guildford, UK, 1 February 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 January 2008, the Company announced that it had been notified by the FDAthat the above IND remained on clinical hold, with a small number of furtherhold issues requiring resolution. In the announcement, the Company stated itsintention to meet with the FDA to discuss and agree an approach to resolvingthese remaining issues. The Company has since requested a Type A, face-to-face meeting with the FDA, whohave now confirmed that a meeting has been scheduled for 14 February. A Type Ameeting is a recognised regulatory review meeting between the FDA and theapplicant. One of the principal purposes of such a meeting is to address theissues that have resulted in a clinical hold and clarify the necessary steps toenable the therapeutic development programme in question to proceed. The Company will make further announcements concerning the outcome of the Type Ameeting when the formal minutes of the meeting become available, usually within30 days of the meeting date. Michael Hunt, Chief Executive Officer of ReNeuron, said: "We are grateful to the FDA for allowing us the opportunity to meet with themin the near term to clarify and resolve the remaining clinical hold issuesregarding our ReN001 stroke therapy. In the meantime, and as mentioned inearlier announcements, we continue our preparations for the clinical phase ofdevelopment of ReN001." Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560 Financial DynamicsDr John Sinden, Chief Scientific OfficerEuropeDavid Yates Tel: +44 (0) 20 7831 3113Lara MottUSRobert Stanislaro Tel : +1 212 850 5657 Collins StewartTim Mickley Tel: +44 (0) 20 7523 8000 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. There arean estimated 50 million stroke survivors worldwide, approximately one half ofwhich are left with permanent disabilities. The annual health and social costsof caring for these patients is estimated to be in excess of £5 billion in theUK and in excess of US$50 billion 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 acquired the business assets of AmCyte Inc. inthe US, bringing clinically-tested cell encapsulation technology to ReNeuron'sReN002 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