Interim data from clinical trial of ReNeuron?s stem cell therapy for stroke to be presented at leading scientific conference
Data show no safety concerns and evidence of sustained reductions in neurological impairment and spasticity
Guildford, UK, 14 June 2012: ReNeuron Group plc (the “Company”) (LSE: RENE.L) is pleased to announce the presentation of interim data from the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, ReNeuron’s ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.
The primary aim of the study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.
To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.
No cell-related adverse events or adverse immune-related responses were reported in any of the patients treated to date. A number of the patients experienced minor procedure-related adverse events such as asymptomatic bleeds or superficial scalp infections at the implantation wound site.
Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.
Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).
Spasticity was measured using the Summated Ashworth Scale for affected upper and lower limbs, a higher score representing a higher degree of spasticity. The pre-treatment mean score for the first five patients was 28.6 (range 12 to 55) and the three month post-treatment mean score was 21.8 (range 5 to 42).
Functional magnetic resonance imaging (fMRI) data were also collected pre- and post-treatment to identify potential biomarkers of change in neurological function in the brains of the treated patients. Some longitudinal changes in motor activation fMRI were seen, consistent with the observed improvements in neurological measures.
The interim data from the PISCES clinical trial is being presented today as a poster presentation by the clinical team at Glasgow at the 10th Annual Meeting of the International Society for Stem Cell Research in Yokohama, Japan, running from 13-16 June 2012.
The PISCES study is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. The trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.
As announced recently, the Company expects that, subject to a continuing lack of cell-related adverse events and affirmative Data Safety Monitoring Board advice, the remaining higher dose cohorts in the PISCES study will have been treated within the next twelve months, leaving the Company on track to submit an application for a Phase II clinical study with ReN001 during the course of 2013.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“The PISCES clinical trial is primarily a safety study and we must therefore treat any of the observed early indications of functional benefit of our ReN001 stroke treatment with considerable caution at this stage. That said, we remain encouraged by the results seen in the study to date and we look forward to providing further updates on the study as the higher dose cohorts are treated and to progressing our planning for further clinical trials 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 remain pleased and encouraged by the data emerging from the PISCES study to date. The data indicate that the ReN001 treatment has a good safety profile at the doses administered thus far. The preliminary signals of potential functional benefit, whilst intriguing, will require further investigation in a suitably designed Phase II efficacy study. The clinical team looks forward to dosing patients in the remaining higher dose cohorts in the PISCES study over the coming months.”
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Posted: June 2012