Living Cell Technologies Ltd (ASX:LCT) has revealed statistically significant improvements in patients who received NTCELL capsule implantation on the brain, in the phase IIb study of NTCELL for Parkinson’s disease.
NTCELL is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells that are sourced from a unique herd of pathogen-free pigs.
Following implantation into a damaged site within the brain, NTCELL functions as a neurochemical factory secreting multiple nerve growth factors that promote new central nervous system growth and repair disease-induced nerve degeneration.
The study was designed to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group.
Efficacy was measured using the Unified Parkinson’s Disease Rating Scale (UPDRS).
Initial data from the 18-month follow up of 18 patients show a statistically significant improvement (p = <0.05) in the UPDRS in the patients who received 80 NTCELL capsules implantation to the putamen on both sides of the brain as compared to the placebo group that received sham surgery.
No benefit was observed when 120 NTCELL capsules were implanted, there being evidence of inflammation which may have compromised efficacy in this group.
NTCELL trial: Initial analysis of 18 month data shows a statistically significant improvement (p = <0.05) in the UPDRS in patients who received 80 NTCELL capsules in the putamen on both sides of the brain as compared to the placebo group. https://t.co/BOQYWSkeWo pic.twitter.com/r6IiroBUSi— LCT Global (@LCTGlobal) November 1, 2018
Auckland City Hospital principal investigator Dr Barry Snow said: “The statistical improvement seen at 12 months has been sustained; variation between recipients is expected with the small number of subjects.
“The next step is further in-depth analysis to understand the data on all efficacy measurements both on and off normal symptomatic treatment.”