MEDIA RELEASE PR35186
Living Cell Technologies' Diabetes Clinical Trial Authorized by New Zealand Government
SYDNEY and AUCKLAND, June 24 /Medianet International-AsiaNet/ --
Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that the New Zealand
Minister of Health, the Honourable Tony Ryall, has authorized LCT's New Zealand Phase I/IIa clinical trial of
DIABECELL® for insulin dependent diabetes.
The authorization confirms the conditions announced on 19 June 2009. One condition of the new
authorization limits participation in the trial to patients with poorly controlled (brittle) diabetes. The remaining
conditions are procedural rather than substantive in nature and LCT and the Middlemore Hospital clinical
team conducting the trial, have requested the Regional Ethics Committee formally accept the changes
required by the Minister.
LCT CEO Dr Paul Tan said: "We are pleased that the conditions have been finalized and LCT looks
forward to commencing the trial within the next two months with the acceptance of the changes by the
Ethics Committee."
Professor Bob Elliott, LCT Founder and Medical Director added: "The New Zealand diabetes trial is
another major milestone for LCT. With two diabetes patients not requiring insulin following implants with
encapsulated pig islet cells in our first study in Russia, we expect to see further benefit in more patients as
we use higher doses of DIABECELL® in the New Zealand trial."
LCTs Phase I/IIa clinical trial in Russia started with a low dose of DIABECELL®. In May 2009 LCT
reported preliminary data showing sustained long term clinical benefit in patients treated with the
DIABECELL® implant with no remarkable adverse events. Remarkably, two of seven patients given
implants are now off insulin injections.
The New Zealand trial allows LCT to extend its Phase I/IIa clinical data with eight patients, four of whom
are to receive double the initial dose used in Russia followed by four patients to receive triple the dose.
Dr John Baker, Clinical Director and Diabetes Physician at Middlemore Hospital, Auckland, who will be
conducting the trial said, "There are many patients with poorly controlled diabetes who would qualify for this
trial."
DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers. DIABECELL®
comprises encapsulated porcine insulin-producing cells which can be administered without the need to use
immunosuppressive drugs.
Type 1 diabetes occurs when the body's own immune system destroys the insulin-producing cells of the
pancreas (called beta cells). Five to 10 percent of the more than 200 million diabetics worldwide have
insulin dependent type 1 diabetes. Type 1 diabetes is associated with kidney failure, blindness, nerve
damage, life-threatening cardiovascular disease and limb amputations. Current treatment options include
multiple daily injections of insulin.
CONTACT: Dr. Paul Tan
Chief Executive Officer
Mob: 021 608 784 (NZ)
Tel:+64 9 276 2690
ptan@lctglobal.com
Mr John Cowan
Finance & Administration Manager
Tel: +64 9 276 2690
jcowan@lctglobal.com
Prof. Bob Elliott
Medical Director
Mob: +64 27 292 4177
Tel:+64 9 276 2690
relliott@lctglobal.com
Paul Dekkers
Investor and Media Relations
Tel: +612 9237 2800
pdekkers@bcg.com.au
SOURCE: Living Cell Technologies
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