Living Cell Technologies Limited (ASX: LCT) has presented the trial results from the Phase IIb study of NTCELL for Parkinson’s disease. The trial commenced in March month of year 2016. The lead product of LCT, which is NTCELL is a capsule coated with alginate and has neonatal porcine choroid plexus cells based clusters.
NTCELL when it gets planted, works as a biological factory that induces factors to promote the development of new growth of the central nervous system and repair disease due to nerve degeneration. NTCELL has significant potential and finds utility in a diverse set of central nervous system indications. These include Alzheimer’s and motor neuron diseases such as amyotrophic lateral sclerosis.
The company has presented this data with the study conducted on 18 patients with the 18 months follow in the phase IIb study of NTCELL. The study was done in order to confirm about the most effective dose of NTCELL and to define the response of any placebo component. The study also finds support in cases wherein identification of initial target Parkinson’s disease becomes crucial.
Three groups were made with each group consisting of six patients during the study. Two patients from each group undergone sham surgery with no implantation of the NTCELL to act as a control. 40 microcapsules of NTCELL implanted on each side of the brain were received by the group 1, 80 microcapsules of NTCELL received by the group 2 and 120 microcapsules of NTCELL received by the group 3.
Unified Parkinson’s disease rating scale consisting of four sub-scales, one of which is motor examination is used to measure the efficacy. All the measurements are recorded when patients are off symptomatic treatments.
Statistically significant improvement with p<=0.05 as measured through unified Parkinson’s disease rating scale in the patients who were implanted with 80 NTCELL capsules to the putamen on both sides of the brain was noted as compared to the placebo group who had sham surgery during the initial analysis of the 18-month data. However, no such benefit was noted from the group 3 who have received 120 microcapsules on NTCELL capsules. Evidence of inflammation was noted which may have compromised efficacy in this group.
Dr Barry Snow from Auckland City Hospital, the principal Investigator for the Phase IIb study of NTCELL for Parkinson’s disease stated that statistically significant improvements were noticed for 12 months and have remained at sustained levels with slight variation between the recipients on small number of subjects.
The next step in this direction is further in-depth analysis to completely understand the data on all efficacy measurements both on and off normal symptomatic treatment. The company will have a clear picture and will be able to confirm on its ongoing strategy for NTCELL once an in-depth analysis of the data along with appropriate discussions with the concerned regulatory authorities at New Zealand are done.
LCT with its previous day close at $0.051 to an intraday high of $0.075, has initially recorded approximately 47% upside in today’s session and is currently trading at the levels of $0.056 (up 9.8% on November 02, 2018, 3:45 PM AEST).
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