Living Cell Technologies' Diabetes Clinical Trial Authorized by New Zealand Government
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Living Cell Technologies' Diabetes Clinical Trial Authorized by New Zealand
Government
SYDNEY and AUCKLAND, New Zealand, June 24 /PRNewswire/ -- 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(R) 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(R) in the New Zealand trial."
LCTs Phase I/IIa clinical trial in Russia started with a low dose of
DIABECELL(R). In May 2009 LCT reported preliminary data showing sustained long
term clinical benefit in patients treated with the DIABECELL(R) 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(R) is designed to normalize blood glucose levels in type 1 diabetes
sufferers. DIABECELL(R) 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.
For further information: www.lctglobal.com.
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
Dr. Paul Tan, Chief Executive Officer, Mob: +021-608-784 (NZ), Tel:
+64-9-276-2690, or ptan@lctglobal.com, Mr. John Cowan, Finance &
Administration Manager, Tel: +64-9-276-2690, or jcowan@lctglobal.com, Prof.
Bob Elliott, Medical Director, Mob: +64-27-292-4177, Tel: +64-9-276-2690, or
relliott@lctglobal.com, all of Living Cell Technologies; Paul Dekkers,
Investor and Media Relations, Tel: +1-612-9237-2800, or pdekkers@bcg.com.au,
for Living Cell Technologies
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