Mental HealthLiving Cell Technologies' Diabetes Clinical Trial Authorized By New Zealand Government
Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) 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.
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