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.”Editor's Details
Last updated on: 06/09/2016
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