Publication of positive pre-clinical retinal data

RNS Number : 9275E

ReNeuron Group plc

22 July 2016

 

 

AIM: RENE

22 July 2016

ReNeuron Group plc

Publication of positive pre-clinical data from retinal stem cells  

ReNeuron's hRPC stem cells arrest visual decline in pre-clinical models of retinal degeneration, demonstrating their therapeutic potential

ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce the publication in a peer-reviewed scientific journal of further key pre-clinical efficacy data with its human retinal progenitor cells (hRPCs).  A Phase I/II clinical trial has recently commenced in the US to evaluate the safety, tolerability and preliminary efficacy of the hRPCs in patients with the inherited blindness-causing disease, retinitis pigmentosa (RP).

The paper, "Efficacy and safety of human retinal progenitor cells", has been published in the journal Translational Vision Science & Technology (TVST) and describes work undertaken in conjunction with ReNeuron's research collaborators at UCL Institute of Ophthalmology, London, and Schepens Eye Research Institute of Massachusetts Eye and Ear, Boston, US.  The studies assessed the long-term efficacy and safety of ReNeuron's hRPCs using established pre-clinical rodent models and gave positive results. 

The hRPCs were well tolerated, safe and preserved retinal structure and vision up to six months post-injection in the studies.  The cells also survived and integrated into both damaged and normal neural retina without adverse affects.  These findings suggest that, as well as treating later stage retinal disease, the hRPCs can be deployed in less affected regions of the retina at earlier stages of retinal disease or even in normal regions of peripheral retina.

The paper can be viewed at:

http://tvst.arvojournals.org/article.aspx?articleid=2535245

(Semo et al. Translational Vision Science & Technology July 2016, Vol.5, 6. doi:10.1167/tvst.5.4.6)

ReNeuron has used the above pre-clinical data, as well as earlier, positive pre-clinical data to support the clinical development of its hRPC cell therapy candidate, initially in patients with RP.  The ongoing Phase I/II clinical study is being conducted at Massachusetts Eye and Ear in Boston, a teaching affiliate of Harvard Medical School. 

As previously announced, initial short-term safety and tolerability data from the Phase I part of the study in the first nine patients are expected in early 2017.  Longer-term safety data, as well as efficacy read-outs from the Phase II part of the study in a further six patients, are expected in the second half of 2017. 

Olav Hellebø, Chief Executive Officer of ReNeuron, said:

"We are pleased to see the publication of further positive pre-clinical data from our hRPC retinal stem cells in a quality peer-reviewed scientific journal.  We are grateful to our scientific collaborators in the UK and the US who have helped us to take this technology into its clinical development phase, initially targeting retinitis pigmentosa.  We look forward to reporting data from the ongoing US Phase I/II clinical trial in RP patients during the course of next year."

ENDS

ENQUIRIES:

ReNeuron	[phone]
Olav Hellebø , Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan	[phone]
Mark Court, Sophie Cowles, Stephanie Watson
Stifel Nicolaus Europe Limited	[phone]
Jonathan Senior, Stewart Wallace, Ben Maddison (NOMAD and Broker)

About ReNeuron

ReNeuron is a leading, clinical-stage cell therapy development company.  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 has therapeutic candidates in clinical development for motor disability as a result of stroke, for critical limb ischaemia and for the blindness-causing disease, retinitis pigmentosa.   

ReNeuron is also advancing its proprietary exosome technology platform as a potential new nanomedicine targeting cancer and as a potential delivery system for gene therapy treatments.

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.

This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate.  A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements. 

 

END

 

 

RESMMGZNGMGGVZZ