RENE.L Regulatory News (RENE)

23 Aug 2006 07:01

ReNeuron Group plc23 August 2006 ReNeuron appoints Principal Investigator for Phase l clinical study with its ReN001 stem cell therapy for stroke Guildford, UK, 23 August 2006: ReNeuron Group plc (LSE: RENE) today announcesthat it has appointed Professor Douglas Kondziolka MD, MSc, FRCS, FACS asPrincipal Investigator for the Phase l clinical study with its ReN001 stem celltherapy for disabled stroke patients. This appointment represents a furtherstep in ReNeuron's preparations for the clinical phase of its developmentprogramme for ReN001. The Company intends to file an Investigational New Drug(IND) application for ReN001 with the US Food and Drug Administration (FDA)before the end of 2006. Approval of this application will open the way tocommencement of a Phase I clinical study in the US, placing ReN001 at theforefront of clinical-stage neural stem cell treatments for major neurologicalconditions. Professor Kondziolka is the Peter J. Jannetta Professor and Vice-Chairman ofNeurological Surgery, University of Pittsburgh. He is an eminent neurosurgeonand a leading expert in the delivery of cell therapy treatments to strokepatients. He has pioneered a number of neurological procedures in this field aswell as developing some of the specialised equipment required to deliver cellsto defined locations within the patient's brain. Professor Kondziolka works with an experienced clinical team at the Universityof Pittsburgh Medical Center (UPMC), the site chosen by ReNeuron for the Phase Iclinical study with ReN001. This centre also works closely with staff at thenearby Immunologic Monitoring and Cellular Products Laboratory at the HillmanCancer Center, UPMC, where suspensions of ReNeuron's ReN001 stem cells will beprepared locally for use in the studies. This is an FDA-approved facilityoperating to Good Manufacturing Practice (GMP) standards. As a consequence of his appointment as Principal Investigator, ProfessorKondziolka will relinquish his responsibilities as a member of ReNeuron'sClinical Advisory Board. Commenting on his appointment, Professor Kondziolka said: "Stem cell therapy holds tremendous promise for patients with disablingneurological diseases. I am excited by the potential of ReNeuron's ReN001treatment for stroke, and I look forward to continued participation in thedevelopment of this therapy when it enters the clinical phase." Michael Hunt, Chief Executive Officer of ReNeuron, said: "We are delighted that Dr Kondziolka has agreed to lead our ReN001 Phase lclinical study in stroke. His credentials in the field are outstanding and,when approved, the early clinical phase of our ReN001 programme will be in safehands. This study will represent the first time that stem cells produced usingReNeuron's proprietary c-mycERTAM expansion technology will have been used totreat a patient. We greatly look forward to that milestone event in theCompany's history." Enquiries: ReNeuronMichael Hunt, CEO Tel: 44 (0)1483 302 560 John Sinden, CSO Financial DynamicsDavid Yates Tel: 44 (0)20 7831 3113 Sarah Macleod Notes to Editors ReNeuron is a leading, UK-based adult stem cell therapy business. The Group 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 means of a chemically-induced safetyswitch. Cell growth can therefore be completely arrested prior to in vivoimplantation. The Group's lead stem cell therapy, ReN001 for chronic stroke disability, is inlate pre-clinical development. Subject to successful completion of pre-clinicaltesting, the Company plans to file for approval to commence a Phase I clinicalstudy in stroke by the end of 2006, with the study commencing as soon aspossible thereafter. The Group has also generated pre-clinical efficacy data with its ReN005 stemcell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder that affects around 1 in 10,000 people. Thisprogramme is in pre-clinical development. In addition to its stroke and Huntington's disease programmes, ReNeuron isdeveloping stem cell therapies for Parkinson's disease, Type 1 diabetes anddiseases 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. ReNeuron's shares are traded on the London AIM market 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. This information is provided by RNS The company news service from the London Stock Exchange