PISCES II is a single arm, open-label study in patients living with disability resulting from ischaemic stroke. Eight centres across the UK’s NHS hospital service were involved in recruiting and treating the 23 patients in the study.
The study’s primary endpoint was a two-point improvement in the grasping and lifting test, sub-test number 2, of the Action Research Arm Test (“ARAT”), at 3 months post-treatment. One patient (4.4%) had a response on ARAT item 2 at 3 months post-treatment, so the primary efficacy endpoint was not met. However, at 12 months post-treatment, a response rate of 15% was observed. In fact, a total of 4 patients showed a response throughout the study period. Subgroup analysis consistently showed that all 4 patients with a response were in a group of 14 patients who had an NIHSS upper limb (UL) score <4 prior to treatment.
Strongly positive results were also observed in the other endpoints of the study.
Total ARAT: Response rates (>6 points from baseline) were measured in 5 responders: 3 responders at 3 months, one more at 6 months, and a further one at 12 months. These subjects had maintained or increased response at all visits. Subgroup analysis consistently showed that all subjects with a response had a NIHSS UL score <4 at baseline.
Modified Rankin Scale (mRS): Response rates (>1 point improvement from baseline) were measured in 35% of subjects at 12 months post-CTX treatment on the mRS, a 7 point, clinician-reported global measure of disability and dependence upon others in carrying out activities of daily living, A one point improvement in mRS is proven to be clinically meaningful for patients, both in terms of quality of life and healthcare resources needed to care for them. Subgroup analysis showed subjects with NIHSS UL score <4 at baseline an even higher response rate of 50% on the mRS at 12 months post-treatment.
Barthel Index: Response rates (>9 points from baseline) were measured in 47.1% of subjects at both 3 months and 12 months post-CTX treatment treatment.
The PISCES II study also demonstrated that the CTX treatment was safe and well tolerated. The most common adverse events were transitory and related to the surgical procedure, such as headache and nausea.
As a result of the positive data from the PISCES II study, the FDA approved the Company to commence a randomised, placebo-controlled Phase IIb clinical study in the US in patients living with disability post-stroke (PISCES III). Specifically PISCES III is targeting subjects with moderate or moderately severe disability (mRS 3 or 4) and some residual arm movement. The PISCES II study was part-funded by a regenerative medicine and cell therapy development grant from Innovate UK.
Further information regarding our clinical trials, including relevant contact details, may be found on clinicaltrials.gov.