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Group 1 patients successfully treated in Parkinson’s trial

Living Cell Technologies Limited

ACN: 104 028 042
ASX: LCT
OTCQX: LVCLY
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.

– Ends –

For further information: www.lctglobal.com

About Living Cell Technologies

Living Cell Technologies Limited (LCT) is an Australasian biotechnology company improving the wellbeing of people with serious diseases worldwide by discovering, developing and commercialising regenerative treatments which restore function using naturally occurring cells.

LCT’s lead product, NTCELL®, is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells. After transplantation NTCELL functions as a biological factory, producing factors to promote new central nervous system growth and repair disease-induced nerve degeneration.

The Phase I/IIa NTCELL clinical trial in New Zealand for the treatment of Parkinson’s disease met the primary endpoint of safety and reversed progression of the disease after 18 months post implant. Results from this trial were used to design a larger Phase IIb trial 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. This trial commenced in March 2016. If the trial is successful, the company will apply in late 2017 for provisional consent to treat paying patients in New Zealand and launch NTCELL as the first disease modifying treatment for Parkinson’s disease.

In addition to Parkinson’s disease, NTCELL has the potential to be used in a number of other central nervous system indications, including Huntington’s, Alzheimer’s and motor neurone diseases including amyotrophic lateral sclerosis (ALS).

LCT’s proprietary encapsulation technology, IMMUPEL™, allows cell therapies to be used without the need for co-treatment with drugs that suppress the immune system.

LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in New Zealand.

For more information visit www.lctglobal.com or follow @lctglobal on Twitter.


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