Living Cell Technologies' Diabetes Clinical Trial Authorized By New Zealand Government

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25th June 2009, 01:20am - Views: 1325

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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


   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


            Mr John Cowan

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            Finance & Administration Manager

            Tel: +64 9 276 2690


            Prof. Bob Elliott

            Medical Director

            Mob: +64 27 292 4177 

            Tel:+64 9 276 2690


            Paul Dekkers

            Investor and Media Relations 

            Tel: +612 9237 2800


   SOURCE: Living Cell Technologies

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