UK-based stem-cell pioneer ReNeuron has reported further encouraging data from the Phase I PISCES (Pilot Investigation of Stem Cells in Stroke) study of its ReN001 therapy in ischaemic-stroke patients.
ReNeuron now expects to apply to the UK regulatory authorities in early July for approval to start a Phase II trial with ReN001 later this year.
Updated interim data from the PISCES trial were presented at the 22nd European Stroke Conference in London, UK.
Professor Keith Muir of the University of Glasgow, who is leading the trial of ReNeuron’s ReN001 stem cell therapy at the Southern General Hospital in Glasgow, Scotland, reported that data from the first nine patients treated have shown no cell-related or immunological adverse affects.
Most of the patients treated experienced sustained modest reductions in neurological impairment compared with their pre-treatment baseline performance, accompanied by improved ability to undertake routine tasks, Professor Muir told the conference.
A further two patients have been treated since the data were collated and the trial is now drawing to a close, with full results scheduled for publication next year.
“The evidence of functional improvement requires further investigation in a suitably designed Phase II efficacy study and we look forward to being a principal clinical site in that study when it commences,” Professor Muir commented.
Assuming the remaining short-term follow-up data confirm the neural treatment’s favourable safety profile, “we will be able to move the ReN001 therapy
confidently into Phase II clinical development, as planned, later this year”, said Michael Hunt, chief executive officer of ReNeuron.
The Phase II study plan for ReN001 has been adopted by the National Institute for Health Research Stroke Research Network (SRN).
This “important endorsement” will enable ReNeuron to work closely with the SRN on optimising performance against defined targets for site set-up, patient recruitment and monitoring across the various sites participating in the study, the researchers noted.