Biotechnology company Living Cell Technologies (ASX: LCT) has published what could end up proving to be pivotal findings from an 18-month follow up of 18 patients in its existing Phase 2b study of NTCELL, the company’s proposed treatment for Parkinson’s disease.
The biotech company is developing NTCELL, an “alginate-coated capsule” containing clusters of neonatal porcine choroid plexus cells.
One of its main objectives is to demonstrate that when coating the plexus cells with its propriety technology ‘IMMUPEL’, they will be protected from attack by the immune system, and therefore, would not need an immunosuppressive regimen is to be made available for treatment.
The novelty behind NTCELL is that its component parts are sourced from “a unique herd of pathogen-free pigs” bred from stock originally discovered in the remote sub-Antarctic Auckland Islands.
According to Living Cell Technologies, its current study was designed to confirm the most effective dose of NTCELL, to define any placebo component of the response and to “further identify the initial target Parkinson’s disease patient subgroup.”
The study consisted of three groups of six patients. Two patients from each group had “sham” surgery with no NTCELL implanted, thereby acting as a control much like a placebo.
The first group received 40 microcapsules of NTCELL implanted on each side of the brain while a second group received 80 and a third group received 120 microcapsules.
Living Cell Technologies reports that initial analysis of the 18-month data showed a “statistically significant improvement” in the Unified Parkinson’s Disease Rating Scale (UPDRS), a comprehensive 50-question assessment of both motor and non-motor symptoms associated with Parkinson’s that is considered as a standard measure for evaluating the effects of the disease.
More specifically, the data indicated improvement 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, although Living Cell Technologies did confirm there was “evidence of inflammation which may have compromised efficacy in this group.”
The results provide tentative signs that NTCELL capsules could be effective in the treatment of Parkinson’s disease although more clinical data is required to corroborate these initial findings.
“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,” said Dr Barry Snow, the study’s principal investigator based at Auckland City Hospital in New Zealand.
Today’s results could propel Living Cell Technologies to step up its development schedule of NTCELL, although in-depth analysis of existing data and imminent discussions with New Zealand regulatory authorities will need to occur first, according to Living Cell’s CEO Dr Ken Taylor.
“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,” said Mr Taylor.
Parkinson’s disease is currently the second most common neurodegenerative disorder after Alzheimer’s disease, affecting approximately 7 million people worldwide.