AGM Trading Update

RNS Number : 0052J

ReNeuron Group plc

06 September 2016

 

 

6 September 2016

AIM: RENE

ReNeuron Group plc

("ReNeuron" or the "Company")

AGM Trading Update

ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to provide a trading update ahead of today's Annual General Meeting.

We are pleased to report today that all patients have been treated in the PISCES II Phase II clinical trial of our CTX cell therapy candidate for patients with motor disability as a result of ischaemic stroke.  The three-month follow-up data from this study will be available, as planned, in December of this year. Subject to the results of the Phase II study, and as previously announced, we expect to file an application in the first quarter of 2017 to commence a randomised, controlled Phase II/III clinical trial with CTX in patients with motor disability post-stroke. 

The Phase I/II clinical trial of our human Retinal Progenitor Cell (hRPC) cell therapy candidate for retinitis pigmentosa (RP) is also proceeding well. This US study, which is being conducted at Massachusetts Eye and Ear Infirmary in Boston, is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of our hRPC stem cell therapy candidate in fifteen patients with advanced RP.  We are pleased to announce that recruitment and treatment of the first dose cohort of three patients has completed.  The Data Safety Monitoring Board for the study has reviewed the initial short-term safety data from these patients and has agreed that the study should proceed to the next dose cohort.  Safety and tolerability data from the Phase I part of the study in the first nine patients are expected in the first half of 2017, with longer term safety data as well as efficacy read-outs from the Phase II part of the study in a further six patients expected in the second half of 2017. 

Our CTX cell therapy candidate for critical limb ischaemia (CLI) is currently in a Phase I clinical trial in the UK.  CLI is a condition that results in loss of blood flow to the lower limb.  The condition is common in diabetics and can ultimately lead to amputation. This study is progressing to completion and, as planned, we expect to have safety data available from this study by the end of this calendar year.

Finally, pre-clinical studies are continuing in line with plan in our exosome nanomedicine programme. Exosomes are nanoparticles secreted from all cells including ReNeuron's proprietary CTX stem cell line. They play a key role in cell-to-cell signalling and early research with CTX-derived exosomes has demonstrated that they may have a significant effect in regulating cell growth and apoptosis in cancer.  We have selected glioblastoma multiforme (GBM) as the first clinical target for ExoPr0, our first exosome nanomedicine candidate.  GBM accounts for 16 per cent of all diagnosed brain cancers, with 25,000 patients diagnosed per annum in the US and Europe combined.  Our exosome nanomedicine programme benefits from a £2.1 million grant from Innovate UK to fund manufacturing process development as well as pre-clinical efficacy and toxicity testing of the ExoPr0 candidate.

Olav Hellebø, Chief Executive Officer of ReNeuron, said:

"Our therapeutic development programmes remain on track with the next key clinical milestone being Phase II data from the PISCES II study in disabled stroke patients, due in December of this year.  ReNeuron remains well-funded to advance all of its therapeutic programmes through to further significant clinical milestones and we look forward to reporting further progress in the months ahead."

ENDS

ENQUIRIES:

ReNeuron	+4 (0)  20 3819 8400
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. 

 

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