RENE.L Regulatory News (RENE)

6 Feb 2006 07:01

ReNeuron Group plc06 February 2006 ReNeuron announces further positive pre-clinical efficacy data with ReN001 stemcell therapy for stroke Guildford, UK, 6 February 2006: ReNeuron Group plc (LSE: RENE.L) today announcesthat it has generated further positive pre-clinical efficacy data with itsReN001 stem cell therapy for stroke. These follow-on studies were undertaken invalidated rodent models of stroke equivalent to those used in the originalefficacy studies undertaken by the Company. The delivery method and implantlocation of the ReN001 cells in the brain were selected to mimic as far aspossible the protocols that are likely to be followed in human clinical trials.Additionally, the ReN001 cells used in these follow-on studies were drawn fromproduction lots manufactured to cGMP1 standard, equivalent to those that will beused in clinical trials. The follow-on studies were designed to test theeffects of different cell doses on efficacy. The results successfully replicated the positive effects of ReN001 at anequivalent dose to that used in the original efficacy studies. Furthermore, andimportantly, the new studies showed a clear dose-ranging effect, indicating thata higher dose has the potential to reverse both the sensory and motor symptomsassociated with stroke disability. These new results will be presented at the US Center for Business Intelligence's2nd Conference on Commercializing Stem Cells for Therapeutic Applications inCambridge, MA, USA on 9-10 March. They will also form part of the Company'sIND2 data package to support its impending application to the FDA3 to commenceinitial clinical trials in the US with ReN001. A paper describing the Company's original pre-clinical efficacy data with ReN001has been accepted for publication in the Journal of Experimental Neurology andwill appear online shortly. The paper will also form part of a special editionof the Journal on stem cells and ischaemic brain disease that is due to appearin print in May 2006. In the paper, ReNeuron scientists demonstrate the uniquebiological characteristics of ReN001 cells and their ability to reverse chronicsensori-motor deficits in validated rodent models of stroke after injection intothe brain. A separate paper written by the Chairman of ReNeuron's Clinical Advisory Board,Professor Sid Gilman, is due to appear in the same special issue of the Journal,and has already been published on-line. Professor Gilman is the William JHerdman Professor of Neurology at the University of Michigan. In his paper,Professor Gilman describes time course factors and current treatment optionsavailable or in development for stroke patients as they move from the acute tosub-acute and chronic phases of their condition. The current lack of treatmentoptions for patients left with permanent disabilities is highlighted, thesub-group ReNeuron is targeting with its ReN001 stem cell therapy and whichaccounts for approximately one half of all stroke survivors. Michael Hunt, Chief Executive Officer of ReNeuron, said: "The results of these follow-on studies are highly significant and will form animportant part of our IND data package for ReN001. They further demonstrate thecapability of our c-mycERTAM platform technology to produce stem cell lines thatare stable, capable of rapid and efficient scale-up, and repeatedly efficaciousin validated pre-clinical models of major disease conditions." 1. Current Good Manufacturing Practice 2. Investigational New Drug 3. US Food and Drug Administration Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: 01483 302 560John Sinden, Chief Scientific Officer Financial DynamicsDavid Yates Tel: 020 7831 3113Sarah Macleod Notes to Editors About ReNeuron Group plc 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 means of a chemically-induced safetyswitch. Cell growth can therefore be completely arrested prior to in vivoimplantation. 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 later this year, with trialscommencing as soon as possible thereafter. The Company has also generated pre-clinical efficacy data with its ReN005 stemcell therapy for Huntington's disease, a rare, genetic and fatalneurodegenerative disorder which affects around 1 in 100,000 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. 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. 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. 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