RENE.L Regulatory News (RENE)

22 Sep 2005 10:31

ReNeuron Group plc22 September 2005 PRESS RELEASE ReNeuron Group plc holds key meeting with the FDA regarding its ReN001 stem cell therapy for stroke Guildford, UK, 22 September 2005: ReNeuron Group plc (LSE: RENE.L) todayannounced that it has held a formal pre-IND(1) meeting with the CBER(2)component of the US Food & Drug Administration (FDA) regarding its lead ReN001stem cell therapy to treat chronic disability after stroke. The Company attended the meeting in July with reviewers from CBER, the groupwithin the FDA responsible for the evaluation of biologics, including cell andgene therapies. The pre-IND meeting followed informal discussions with membersof CBER concerning the ReN001 programme, and the subsequent submission of apre-IND dossier by the Company. The Company has now received and reviewed the official minutes of the pre-INDmeeting. As a result, ReNeuron is maintaining its pre-clinical developmenttimelines for its ReN001 stroke programme and, subject to successful completionof pre-clinical testing, remains confident of achieving its goal of filing anIND application (to commence initial clinical trials) with the FDA by mid-2006. Whilst working to meet the FDA's pre-clinical requirements with respect to theReN001 programme, ReNeuron is also meeting with the equivalent UK and Europeanregulators in order to determine the regulatory requirements for ReN001 inEuropean markets. Commenting on the announcement, Michael Hunt, CEO of ReNeuron, said: "ReNeuron's ReN001 stem cell therapy for stroke is a pioneering developmentprogramme, and therefore one where we believe collaboration between ReNeuron andthe regulatory authorities is critical in defining the safety and performancecriteria for the therapy. We are grateful to the CBER team for theirconstructive comments and assistance in helping the Company to define the mostappropriate development strategy for ReN001, and we look forward to furtherpositive interaction with CBER and the regulatory authorities in Europe asReN001 progresses towards the clinic." (1)Investigational New Drug (2)Center for Biologics Evaluation and Research Enquiries: ReNeuronMichael Hunt, CEO Tel: 01483 302 560John Sinden, CSO Financial DynamicsDavid Yates Tel: 020 7831 3113Sarah Macleod 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. If this application is successful, the Companybelieves that its ReN001 programme would be the world's first clinical-stageneural stem cell therapy for stroke patients. 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 such as drug discovery - its ReNcell product. 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. 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