Group 2 Parkinson’s trial patients’ treatment completed

Group 2 Parkinson’s trial patients’ treatment completed

22 December 2016 – Sydney, Australia & Auckland, New Zealand – Living Cell Technologies Limited has completed treatment of all six patients in group 2 of the Phase IIb clinical trial of NTCELL® for Parkinson’s disease, at Auckland City Hospital. Four patients had 80 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 first five patients in the group were treated between 12 and 19 November. The ability to treat five patients in eight days demonstrates that the company’s internal procedures are working well and the team is meeting the very high standards demanded by the clinical trial protocol.

Auckland City Hospital’s purchase of an additional stereotaxic frame means that the neurosurgical team is able to increase the number of procedures performed. This has contributed to the increased treatment rate in this second group of patients, as has the scheduling of dedicated surgical sessions for trial patients.

Dr Barry Snow’s recent presentations to Parkinson’s New Zealand in Auckland were instrumental in identifying patients who met the treatment criteria for the study, some of whom were treated in group 2.

The next step is for the Data Safety Monitoring Board to consider giving approval to treat the six patients in group 3 with the next dose of NTCELL (120 microcapsules implanted into the putamen on each side of their brain).

The company plans to complete group 3 by the end of February 2017. The company is blind to the results until 26 weeks after completion of group 3 of the trial, at which point the patients who received the placebo will receive the optimal dose of NTCELL.

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.
“Our goal, subject to continued satisfactory data, is to obtain provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson’s disease early in 2018,” says Dr Ken Taylor, CEO of LCT.
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