AGM Trading Update

RNS Number : 5681Q

ReNeuron Group plc

02 September 2014

 

2 September 2014                                                                                                        AIM: RENE

ReNeuron Group plc

 AGM Trading Update

Guildford, UK, 2 September 2014:  ReNeuron Group plc (the "Company") (AIM: RENE), a leading UK-based stem cell therapy company, is pleased to provide a trading update ahead of today's Annual General Meeting.

In the Company's June preliminary results statement, we reported that recruitment had opened for the Phase II clinical trial with our ReN001 cell therapy candidate for stroke disability.  We also reported that recruitment had commenced in a Phase I clinical trial of our ReN009 cell therapy candidate for critical limb ischaemia.   Since then, the first patient has been dosed in both of these clinical trials. 

The Phase II efficacy study with ReN001 will recruit up to 41 stroke patients at up to ten clinical sites across the UK.  The dose level is 20 million CTX cells in each patient.  The primary endpoint is a meaningful improvement in upper limb function in disabled stroke patients six months post-stroke to a degree that would support reimbursement of the therapy by healthcare payers on a Quality Adjusted Life Year basis. The Phase I safety study with ReN009 is a single centre dose escalation study in nine patients with lower limb ischaemia and is being conducted at Ninewells Hospital, Dundee, Scotland. In the study, three dose cohorts of three patients each will receive doses of 20 million, 50 million and 80 million CTX cells, respectively.

The Phase II clinical trial with ReN001 is on course to have generated six month follow-up data by the end of 2015.  We also remain on course to announce results from the Phase I study with ReN009 in the first half of 2015.

The final pre-clinical work on ReN003, our cell therapy candidate for retinitis pigmentosa, is proceeding as planned and we remain on track to file an IND application in early 2015 to commence a Phase I/II clinical trial with ReN003 in the US.

Elsewhere in the business, our exosome programme is proceeding well, with pre-clinical efficacy studies underway in order to determine the disease areas to target for clinical development with exosome-based therapies in the future.  We also remain on track with our plans to relocate ReNeuron's operations to a state-of-the-art manufacturing and development facility at Pencoed, near Cardiff in South Wales, in the Spring of 2015.

Finally, the planned recruitment of a new CEO for the business is proceeding well and we have been impressed by the exceptional quality of applicants for the role.  We expect to be able to conclude the recruitment process shortly.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

"Our core therapeutic programmes remain on track towards further important clinical milestones over the next 18 months.  In particular, the commencement of dosing of patients in two new clinical trials, in stroke and limb ischaemia, marks another significant step in ReNeuron's evolution into a fully-fledged clinical development business and a leading player in the increasingly exciting field of cell therapy and regenerative medicine.''

Enquiries:

ReNeuron                                                                                 [phone]

Michael Hunt, Chief Executive Officer

Buchanan                                                                                   [phone]

Mark Court, Fiona Henson, Sophie Cowles                                                    

Cenkos Securities                                                                    [phone]

Stephen Keys, Dr Christopher Golden (NOMAD and Broker)

Andy Roberts (Sales)

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 in clinical development and its cell-based treatment for blindness-causing diseases of the retina is currently in pre-clinical development. 

ReNeuron is also advancing a proprietary platform technology to exploit nanoparticles (exosomes) secreted by stem cells as potential new drug candidates targeting indications in tissue repair, fibrosis and 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.

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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