Living Cell Technologies Limited has completed treatment of all six patients in group 1 of the Phase IIb clinical trial of NTCELL® for Parkinson’s disease, at Auckland City Hospital. Four patients had 40 NTCELL microcapsules implanted into the putamen on each side of their brain, and two patients had sham surgery with no NTCELL implanted. To date there are no safety issues in any of the six patients.
The company is blind to the results until 26 weeks after completion of the trial, at which point the patients who received the placebo will receive the optimal dose of NTCELL.
The next step is the Data Safety Monitoring Board reviewing the patients’ results and giving approval to treat the six patients in group 2 with the next dose of NTCELL (80 microcapsules implanted into the putamen on each side of their brain).
Principal Investigator Dr Barry Snow presented data from the earlier Phase I/IIa clinical trial to prospective patients and their partners and supporters at meetings organised by Parkinson’s New Zealand. These meetings were oversubscribed and have assisted patient recruitment for the clinical trial.
Auckland City Hospital has invested in additional equipment and arranged extra surgical sessions dedicated to treating multiple patients in the clinical trial. These measures will accelerate trial progress.
The company plans to complete group 2 by the end of 2016 and group 3 by the end of February 2017.
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 in Q4 2017.
For further information: www.lctglobal.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20161004006702/en/Business Wire
Last updated on: 05/10/2016
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