ReNeuron Group plc provides a further update on the PISCES Phase I clinical trial of its ReN001 stem cell therapy for disabled stroke patients ahead of the commencement of a Phase II efficacy study for which patient enrolment has now opened.
Long term follow-up data out to 12 months in all patients treated in the PISCES study are being presented in two platform presentations by the clinical team from Glasgow’s Southern General Hospital at the 23rd European Stroke Conference, taking place in Nice, France this week.
There were no cell-related or immunological adverse events reported in any of the eleven patients treated in the study. Adverse events were related only to the implantation procedure or underlying co-morbidities. Sustained reductions in neurological impairment and spasticity were observed in most patients compared to their stable pre-treatment baseline performance, reflected in the summary evaluation scores below (n=11 patients):
• National Institutes of Health Stroke Scale (measure of neurological deficit):
o Trial inclusion criteria require a score of 6 or more, representing stable moderate to severe disability (total of 2 or more for motor arm and leg scores)
o Median pre-treatment score = 7
o Post-treatment scores improved by median 2 points at 3 months and 3 points at 12 months
• Barthel Index (measure of independence in performing activities of daily living, rated 0-20):
o Median pre-treatment score = 12
o Post-treatment scores improved by median 1 point at 3 months and 3 points at 12 months
• Summated Ashworth Score (aggregated measure of spasticity in affected limbs, rated 0-40 arm, 0-25 leg):
o Mean pre-treatment aggregate score = 29
o Post-treatment scores improved by mean 5 points at 3 months and 7 points at 12 months
• Modified Rankin Score (overall measure of disability and handicap, rated 0-6):
o Median pre-treatment score = 3
o Score improved by 1 grade in n=4/11 patients at 12 months, with n=7/11 patients unchanged
• EuroQOL score (quality of life outcome measure, rated 0-100):
o Median pre-treatment score = 45
o Post-treatment scores improved by median 18 points at 12 months.
Preliminary functional MRI data in seven of the treated patients at resting state show, at a group level, evidence of increased short-term connectivity between the cell-implanted region of the brain (the putamen) and the other deep brain regions that are concerned with sensory motor control, although relevance to functional outcomes in the patients requires further evaluation.
The Company recently announced that it had received unconditional approval to conduct a UK multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke. This Phase II study is now open for patient enrolment at the Glasgow clinical site, with other UK centres expected to follow, as required, over the coming weeks and months.
The study will involve the treatment of up to 41 patients between 8 and 12 weeks after their stroke. Patients will be monitored on a number of validated stroke efficacy measures up to six months post-treatment. The treatment window in the Phase II clinical trial is regarded as optimal in terms of the potential efficacy of the ReN001 therapy and differs from the treatment window in the PISCES Phase I clinical trial where patients were treated at least 6 months after their stroke.
Michael Hunt, Chief Executive Officer of ReNeuron, said: “The PISCES study has continued to yield encouraging results in longer term follow up of the patients treated with ReN001, providing further evidence of the safety of the treatment and some evidence of the potential positive effects of the treatment against baseline measures of disability. This is gratifying and bodes well for our recently approved Phase II clinical trial with ReN001.”
Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow, and Principal Investigator of the PISCES study, said: “We are pleased and encouraged by the data from the PISCES study. The long term follow-up data continue to demonstrate the safety and tolerability of the ReN001 treatment. The evidence of functional improvement and early imaging data warrant further investigation and, in this regard, we look forward to being a principal participating centre in the recently approved Phase II efficacy study.”