LCT Receives Ethics Approval for Phase IIb Parkinson's Trial
February 03 2016 - 1:30AM
Business Wire
Living Cell Technologies (ASX: LCT) (OTCQX: LVCLY) 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.
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 showed encouraging clinical efficacy improvements. Results from
this trial have been used to design a larger Phase IIb trial to
evaluate its potential as a disease-modifying treatment for
patients with Parkinson’s disease. It has the potential to be used
in a number of other central nervous system indications such as
Huntington’s, Alzheimer’s and motor neurone diseases.
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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version on businesswire.com: http://www.businesswire.com/news/home/20160202006762/en/
At the Company:Living Cell Technologies LimitedKen
Taylor, +64 9 276 2690Chief Executivektaylor@lctglobal.comMobile:
+64 21 796 000orMedia Contact:Botica Butler Raudon
PartnersRachael Joel, +64 9 303 3862rachaelj@botica.co.nzMobile:
+64 21 403 504
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