8 November 2017
ReNeuron Group plc
("ReNeuron" or the "Company")
Retinal disease clinical trial moves into Phase II
Data Safety Monitoring Board gives approval for ongoing retinitis pigmentosa clinical trial to progress into Phase II element based on short term safety data
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, today provides an update regarding the Company's ongoing Phase I/II clinical trial of its hRPC cell therapy candidate for the blindness-causing disease, retinitis pigmentosa ("RP").
The Company is pleased to report that the clinical trial's Data Safety Monitoring Board has given approval for the study to progress into its Phase II element. This decision was based on short term data from the nine RP patients treated in the Phase I part of the study, which indicate that the hRPC cell therapy was safe and well tolerated at the three doses tested.
The final high-dose cohort of patients in the Phase I part of the study was treated with the newly developed cryopreserved formulation of the Company's hRPC cell therapy candidate. Based on the short term safety data, this is the formulation and dose that will be utilised in the Phase II element of the study. This part of the study will recruit six RP patients with less impaired vision than those treated in the Phase I element and will lead to a larger, placebo-controlled Phase IIb clinical trial in similar patients in terms of the progression of their disease.
The Company expects read-outs from the Phase II part of the ongoing RP clinical trial in the second half of 2018, with efficacy data from a subsequent, larger Phase IIb study in 2020. As previously announced, the Company also intends to seek approval to commence a Phase II clinical trial with its hRPC cell therapy candidate in patients with cone-rod dystrophy ("CRD"), to run concurrently with the Phase IIb testing of this candidate in RP. CRD is a group of rare eye disorders associated with a loss of cone cells in the retina that results in deterioration of central visual acuity and colour vision.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted that the Data Safety Monitoring Board has given its approval to progress our ongoing clinical trial in retinitis pigmentosa into its Phase II element. Our hRPC cell therapy candidate offers the potential for an entirely new therapeutic option for patients suffering from diseases of the retina such as retinitis pigmentosa and cone-rod dystrophy, and represents a therapeutic platform technology with high commercial potential for 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 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 drugs that would otherwise be unable to reach their site of action.
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 information is provided by RNS