This sums it up nicely
Cognitive improvement confirmed by Carol and if you listen "all Patients improved by 20%"
The issue was a Double Barreled Primary End Point
To halt the progression of Parkinsons was a success as far as I can remember , to improve was not established and pulled the data back.
Many SH immediately called for the Trial to be carried out again with a single Primary Endpoint "To Halt the Progression"
Management went off on some other tangent to nowhere.....sold the Otsuka JV partnership for $3m when it was valued at $25m on the books..
ASX ANNOUNCEMENT
Group 1 patients successfully treated in Parkinson’s trial
5 October 2016 – Sydney, Australia & Auckland, New Zealand – 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.
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