Ethical approval for LCT’s NTCELL® Phase I trial
Living Cell Technologies
Limited
Company
Announcement
Ethical approval for LCT’s NTCELL® Phase I trial
16 November 2012:
Sydney, Australia and Auckland, New Zealand –
Living Cell Technologies Limited (ASX: LCT; OTCQX:
LVCLY) has received ethical approval from the New Zealand
Ministry of Health’s Health and Disability Ethics
Committee to proceed with Phase I clinical trials of
NTCELL® for Parkinson’s disease.
"We are extremely
pleased to have received ethical approval in such an
efficient timeframe," says Dr Andrea Grant, Chief Executive
of LCT. "It means that LCT is still on track to commence
NTCELL’s first in-human trials in Q1 2013.
LCT
received regulatory authorisation from Medsafe to proceed
with trials in October.
– Ends –
For further information: www.lctglobal.com
About
Living Cell Technologies
Living Cell
Technologies (LCT) leads the world in developing cell-based
therapeutics to treat diseases with high unmet clinical
need. Its proprietary cell encapsulation technology
IMMUPEL™ allows for cell transplantation without the need
for immunosuppressant drugs.
LCT’s lead therapeutic
candidate DIABECELL® is indicated for the treatment of
patients with type 1 diabetes, especially those suffering
from life threatening episodes of unaware hypoglycaemia (low
blood sugar), a dangerous and potentially fatal diabetes
complication. DIABECELL is currently in Phase II clinical
trials in both New Zealand and Argentina.
In 2011, LCT
formed a partnership with Otsuka Pharmaceutical Factory Inc
(OPF) in which the joint venture Diatranz Otsuka Limited
(NZ) was established. Valued at A$50m on formation, LCT
vested the DIABECELL product and associated IP into the JV,
while OPF vested A$25m to fund the final phase of
development of DIABECELL through to market approval. Both
LCT and OPF are 50:50 shareholders in the current and future
value generated by DIABECELL and the associated IP.
LCT
has also developed NTCELL®, a choroid plexus cell product,
to treat neurodegenerative diseases such as Parkinson's
disease and stroke. NTCELL’s trial results indicate
potential for protecting, repairing and possibly
regenerating brain tissue which would otherwise die.
LCT
is incorporated in Australia. Research and development,
operations and manufacturing facilities are based in New
Zealand.