ReNeuron Group plc

("ReNeuron" or "the Company")

FDA gives ReNeuron approval to start a Phase I/II clinical trial in the US

in retinitis pigmentosa

Guildford, UK, 5 May 2015:ReNeuron Group plc (AIM: RENE), a leading UK-based stem cell therapy company, today announces that it has received regulatory approval from the US Food and Drug Administration (FDA) to commence a Phase I/II clinical trial in the US with its human Retinal Progenitor Cell (hRPC) therapy candidate for retinitis pigmentosa (RP).  RP is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.

The Company announced on 13 April 2015 that it had filed an Investigational New Drug (IND) application with the FDA to commence the Phase I/II clinical trial.  The Company has since received notification from the FDA that the review of the application is complete and that ReNeuron is free to begin clinical studies.  ReNeuron's cell therapy candidate for RP has already been granted Orphan Drug Designation in both Europe and the US by the European Commission and the FDA, respectively.

The Phase I/II clinical trial will be conducted at Massachusetts Eye and Ear, Boston, a world-renowned clinical centre for the treatment of retinal diseases.  The trial design is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of the hRPC stem cell therapy candidate in up to 15 patients with advanced RP.  Preparations for the study have commenced and ReNeuron expects the study to begin in the second half of this year. 

Olav Hellebø, Chief Executive Officer of ReNeuron, commented:

"We are delighted to have received regulatory approval to commence our first clinical trial in the US with our hRPC stem cell therapy candidate for RP. It is a testament both to our staff and to the quality of our hRPC technology that this first-in-man clinical trial application was approved so promptly.  We are delighted to be working with Massachusetts Eye and Ear on this important clinical trial and we look forward to initiating the study later this year."

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About Retinitis Pigmentosa

Retinitis Pigmentosa (RP) is the name given to a group of inherited diseases of the retina that lead to a gradual and progressive reduction in vision and is the most common inherited cause of blindness in people between the ages of 20 and 60.  The decline in vision is caused by the death of the photoreceptor cells (both rods and cones) of the retina.  Night blindness and difficulties with peripheral vision are the earliest and most frequent symptoms of RP, with reading and colour vision affected later. The age at which symptoms start is variable and the rate of deterioration of vision also varies from person to person. RP is typically diagnosed in adolescents and young adults and most sufferers will be legally blind by the age of 40.  There are approximately 300,000 people living with RP in the US and Europe.  There is currently no cure for RP and the main treatments used (high dose vitamins) slow the progression of RP in some patients, but also carry the risk of side effects. 

About ReNeuron

ReNeuron is a leading, clinical-stage cell therapy development business.  Based in the UK, its primary objective is the development of novel cell-based therapies targeting areas of significant unmet or poorly met medical need.  

ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered "off-the-shelf" to any eligible patient without the need for additional immunosuppressive drug treatments.  The Company's therapeutic candidates for stroke disability and critical limb ischaemia are already in clinical development and its cell-based treatment for the blindness causing disease, retinitis pigmentosa, is about to enter the clinic in the US. 

ReNeuron is also advancing a proprietary platform technology to exploit nanoparticles (exosomes) secreted by stem cells as potential new drug candidates targeting a range of indications including cancer.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.  Further information on ReNeuron and its products can be found at www.reneuron.com.