ReNeuron's CTX cell therapy candidate has been shown to improve neurological function in patients with stable motor disability following a stroke for at least 24 months, according to long-term data from a Phase I trial published by The Lancet.
In the PISCES I study, improvements in neurological status and limb function compared with pre-treatment baseline performance were observed within three months of treatment and maintained throughout long term follow up.
Improvements in the National Institutes of Health Stroke Scale, which measures neurological impairment caused by a stroke, were seen in all dose groups, improving from a mean baseline of 7.45 to 5.09 at three months and sustained at two years follow up with a mean score of 4.91.
Ashworth Scale scores, a measure of limb spasticity, also showed sustained improvement over the course of the two year study in both the affected arm and leg (mean improvement of 2.5 and 3.7 points), while scores on the Barthel Index, a measure of activities of daily living, also bettered with a median improvement of 2 points two years after treatment.
Safety signals were also encouraging, with no cell-related or immunological adverse events reported in any of the patients treated in the PISCES I study across the four ascending dose levels, the firm noted.
"The long term follow up data from the PISCES I study are both pleasing and encouraging," noted principal investigator of the trial Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow. "The data demonstrate the safety and tolerability of the CTX cell therapy treatment and the evidence of functional improvements have justified further investigation in the ongoing PISCES II efficacy study."
Patient recruitment has completed into the ongoing Phase II PISCES II trial of the CTX cell therapy candidate in stroke; three-month follow up data are expected in the fourth quarter of this year.