Living Cell Technologies has received approval from the Northern A Health and Disability Ethics 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.
The Phase IIb trial follows the successful Phase I/IIa trial, which showed excellent safety data and 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. The company plans to initiate the trial on 24 February 2016.
If the trial is successful the company will apply for provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson’s disease in 2017.