SYDNEY & AUCKLAND, New Zealand--(BUSINESS WIRE)--Living Cell Technologies has received approval from the Auckland Hospital Research Review Committee for the Phase IIb clinical trial of NTCELL® for Parkinson’s disease. The New Zealand Minister of Health authorised the application to conduct the trial on 12 November 2015, and the Northern A Health and Disability Ethics Committee gave its approval on 3 February 2016. The initiation meeting with all those involved in the clinical trial has been held and patient recruitment is under way.
The Phase IIb trial follows the successful Phase I/IIa trial, which met the primary endpoint of safety and showed clinically and statistically significant efficacy data in patients with Parkinson’s disease one year after NTCELL treatment.
The Phase IIb trial aims 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.
If the trial is successful the company will apply for provisional consent to treat paying patients in New Zealand and launch NTCELL as the first disease modifying treatment for Parkinson’s disease, in 2017.
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