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ReNeuron Group Plc receives UK regulatory approvals for Phase II clinical trial in stroke and Phase I clinical trial in critical limb ischaemia


Thursday, 27 Mar 2014 03:00am EDT 

ReNeuron Group Plc:Receives UK regulatory and ethical approvals to commence two new clinical trials.Multi-centre Phase II clinical trial will be undertaken at NHS hospital trusts throughout the UK with the company's ReN001 investigational therapy for disabled stroke patients.The study will involve the treatment of up to 41 patients between 8 and 12 weeks after their stroke.Patients will be monitored on a number of validated stroke efficacy measures up to six months post-treatment.The treatment window in the Phase II clinical trial is regarded as optimum in terms of the potential efficacy of the ReN001 therapy and differs from the treatment window in the Phase I clinical trial with ReN001 where patients were treated at least 6 months after their stroke.Phase II study has been adopted by the NHS National Institute for Health Research Stroke Research Network (SRN).The study is expected to read out by the end of 2015. 

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