Minister authorises Phase IIb Parkinson’s study

12 November 2015 – Sydney, Australia & Auckland, New Zealand – 

Living Cell Technologies Limited’s application to conduct a Phase IIb study of NTCELL® in Parkinson’s disease has been authorised, subject to the usual conditions, by New Zealand’s Minister of Health, Hon Dr Jonathan Coleman

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The study protocol will now be submitted to the ethics committee for approval. Once the committee has approved the study design, patient recruitment can commence.

The study will involve up to 18 patients under the age of 65 who have had Parkinson’s disease for at least 5 years. Patients will be treated in three groups. Each group will receive bilateral implants of NTCELL at a range of doses. In each group, two patients will receive a placebo dose.

At the end of the 26-week follow up period the study will be unblinded, at which point the patients who received the placebo will receive an implant of NTCELL at the dose determined to be most effective.

LCT intends to begin patient recruitment in December 2015. LCT expects the first patient to be implanted in February 2016 and the study will be completed in 2017.

CEO of Living Cell Technologies, Dr Ken Taylor, says the study is the next step in the company’s development of NTCELL as a disease-altering treatment for Parkinson’s disease.

“We’re looking to confirm the ability of NTCELL to halt disease progression and restore quality of life for people with Parkinson’s disease,” says Dr Taylor.

The minister also authorised an amendment to the protocol of the Phase I/IIa study to enable ongoing monitoring of the four patients in that study. Evaluation of the patients at 42 weeks post-implant showed a clinically and statistically significant improvement in their neurological scores from their pre-implant baseline. That improvement is equivalent to approximately 5 years of Parkinson’s disease remission. 

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