RENE.L Regulatory News (RENE)

6 Dec 2006 07:00

ReNeuron Group plc06 December 2006 ReNeuron files IND application to commence human clinical studies with ReN001 stem cell therapy for stroke First such application to use neural (brain) stem cells to treat a major neurological condition Guildford, UK, 6 December 2006: ReNeuron Group plc (LSE: RENE.L) todayannounces the filing of its first Investigational New Drug (IND) applicationwith the US Food and Drug Administration (FDA) to commence initial clinicalstudies in the US with ReN001, its stem cell therapy for stroke. This filing is a key milestone in ReNeuron's history and, the Company believes,the world's first such application concerning a neural stem cell treatment for amajor neurological disorder. Stroke is the single largest cause of adultdisability in the developed world. Over 130,000 people suffer a stroke eachyear in the UK, and over 700,000 people in the US. ReNeuron's ReN001 stem cell therapy seeks to treat those patients who havesuffered a stroke and have been left disabled by it. These patients constituteapproximately one third of the total stroke patient population. There arecurrently no approved treatments available to address the causes of theirdisability. Existing treatments for stroke in the chronic phase are primarilyfocused on the prevention of recurrent strokes. The annual health and socialcosts of caring for disabled stroke patients is estimated to be in excess of £5billion in the UK, with stroke patients occupying 25 per cent of long termhospital beds. In the US, the annual direct and indirect costs of stroke areestimated to be in excess of US$50 billion. Following approval of the IND, the initial clinical study will be conductedunder the direction of Professor Douglas Kondziolka MD, MSc, FRCS, FACS at theUniversity of Pittsburgh Medical Centre. The initial Phase I study with ReN001will be an open label study, with two dose levels, in disabled stroke patients.The primary objective of the study will be to monitor the safety profile of thetreatment. Preliminary efficacy measures will also be recorded, however, toprovide an indication of therapeutic potential ahead of further efficacy studiesin a larger cohort of patients once the safety of the ReN001 therapy has beenconfirmed. Michael Hunt, Chief Executive Officer of ReNeuron, said: "Today's announcement is a significant milestone for ReNeuron and for the widerstem cell field. We have been greatly encouraged by the pre-clinical datagenerated in support of the IND application, and we now look forward to takingReN001 into its clinical phase. The IND filing represents the first steptowards determining the safety and efficacy of our ReN001 therapy in man, inorder to ultimately bring this treatment to the many patients who could benefitfrom it. Importantly, approval of this IND will also provide validation for ourproprietary c-mycER(TAM) cell expansion technology, thereby adding impetus to ourother therapeutic programmes to which this technology has been applied." Professor Kondziolka at the University of Pittsburgh Medical Center, commented: "Our team has participated in the design of ReNeuron's first clinical study andwe are excited about the potential this research offers in the field of brainrepair. This study seeks to address the immense problem of disability followingstroke, for which there are few treatment options." Enquiries: Michael Hunt, Chief Executive OfficerJohn Sinden, Chief Scientific OfficerReNeuron Group plc +44 (0)1483 302560 David Yates, Nicola DaleyFinancial Dynamics - Europe +44 (0)20 7831 3113 Jonathan Birt, John CapodannoFinancial Dynamics - US +1 (212) 850 5755 Note to editors: ReNeuron is a leading, UK-based adult stem cell therapy business. It 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-mycER(TAM) 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. 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. ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem celltherapy for Huntington's disease, a genetic and fatal neurodegenerative disorderthat affects around 1 in 10,000 people. This programme is in pre-clinicaldevelopment. 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. 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. The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement referto ReNeuron Group plc and/or its subsidiary undertakings, depending on thecontext. This information is provided by RNS The company news service from the London Stock Exchange