Living Cell Technologies (ASX: LCT) has advanced plans for a third clinical trial of NTCELL in Parkinson’s disease, following the signing of a Research Agreement with the University of Technology Sydney (UTS) and the Australian Foundation for Diabetes Research (AFDR).
The UTS agreement will allow university facilities to be used to optimise the production of NTCELL in Australia for the first time, prior to the third clinical trial.
Once approved by import authorities, porcine brain tissue (choroid plexus) will be shipped to Sydney from research partner NZeno’s pig facility in Invercargill, New Zealand.
Once the Australian production of NTCELL has been optimised at UTS, the tissue will be sent to a Good Manufacturing Practice (GMP) facility, where it will be manufactured under conditions suitable for it to be used clinically.
Approval for the use of the encapsulated pig tissue will need to be obtained from a Human Research Ethics Advisory Committee and the Therapeutic Goods Administration.
The NTCELL clinical trial for people with early to mid-stage Parkinson’s disease is likely to be the first xenotransplantation trial carried out in Australia after earlier trials in New Zealand.
This is another key step as we advance this potentially groundbreaking research in Australia, following in the footsteps of New Zealand researchers,” LCT Executive Chairman, Professor Bernie Tuch, said.
“Optimising the production of encapsulation pig choroid plexus in Australia is a necessary measure before it is manufactured under GMP conditions for the clinical trial.
“We look forward to getting this work underway as soon as possible, given the pressing need for new treatments for Parkinson’s disease and its impact on the community.”
The first trial participants are expected to receive treatment in 2024. More than 10 million people worldwide are living with Parkinson’s disease, including 100,000 Australians, with the disease estimated to cost the Australian community an estimated $10 billion per year.
The research agreement follows LCT’s announcement on 24 January of the signing of a Services Agreement with NZeno, with the New Zealand biotech breeding and maintaining pigs to provide tissue for the clinical trial.