:( 10 November 2017 – Sydney, Australia & Auckland, New Zealand...

10 November 2017 – Sydney, Australia & Auckland, New Zealand – The results of Living Cell Technologies Limited’s Phase IIb clinical study of NTCELL® for Parkinson’s disease have been unblinded. Three of the four primary endpoints were met. No product or procedure adverse events occurred and there is no evidence of xenogeneic infection in patients and their partners.

However, at 26 weeks post implant, there is not a statistically significant difference between the groups who received NTCELL and the patients who had sham surgery, as measured by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS Part III in the off state). NTCELL is a regenerative cell therapy that had shown potential in early trials as a disease-modifying agent in 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, group 2 80 and group 3 120 microcapsules of NTCELL on each side of the brain. The patients who did not receive NTCELL will receive treatment determined by the Data Safety Monitoring Board (DSMB). At this stage, the DSMB has recommended that no treatment be given to the placebo patients.

The Principal Investigator, Dr Barry Snow, Auckland City Hospital, says “The next step is to analyse the data in depth and continue to monitor patients in accord with the study extension protocol, particularly for the efficacy movements at longer time points.” Dr Ken Taylor, CEO of LCT, says, “While this was a very good study from a safety viewpoint, we are disappointed that the efficacy primary endpoint has not been met.

It is encouraging that some efficacy data is positive and that the treatment was well tolerated and safe. More data analysis and input from our advisors is required but at this time we cannot proceed with a regulatory application.”

Investor call LCT CEO Ken Taylor and Principal Investigator Dr Barry Snow will host an investor call to discuss the results of the Phase IIb clinical study of NTCELL in Parkinson's disease on the day of the announcement. Date: Friday 10 November 2017 Time: NZT 4:00pm, AEST 2:00p