02 November 2018 – Sydney, Australia & Auckland, New Zealand –
LCT has the data from the 18 month follow up of the 18 patients in the Phase IIb study of NTCELL® for Parkinson’s disease. 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.
The study consisted of three groups of six patients. Two patients from each group had sham surgery with no NTCELL implanted, to act as a control. Group 1 received 40 microcapsules of NTCELL implanted on each side of the brain; group 2 received 80; and group 3 received 120. Efficacy is measured using the Unified Parkinson’s Disease Rating Scale (UPDRS) which consists of four sub-scales, one of which is Motor Examination.
All measurements reported below are when patients are off symptomatic treatments. Initial analysis of the 18 month data shows 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.
The principal investigator, Dr Barry Snow, Auckland City Hospital, says “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.” Dr Ken Taylor, CEO of LCT says, “When we have the in-depth analysis of the data and have had appropriate discussions with the New Zealand regulatory authorities, LCT will be able to confirm its ongoing strategy for NTCELL.”
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