Living Cell Technologies Ltd. Enrolls Patients Into New Zealand Diabetes Clinical Trial
22 July 2009: Sydney, Australia, Auckland, New Zealand– Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that the trial of its encapsulated pig islet cell product for insulin dependent diabetes, DIABECELL®, has commenced following authorization by the New Zealand Minister of Health and acceptance of the clinical trial protocol by the Regional Ethics Committee.
Information on its New Zealand Phase I/IIa clinical trial is available on www.ClinicalTrials.gov., a registry that is sponsored by the U.S. National Institutes of Health and provides information about clinical trials from around the world.
LCT CEO Dr Paul Tan said: “The New Zealand trial extends LCT’s clinical program and complements the clinical and commercialisation program in Russia.”
Professor Bob Elliott, LCT Founder and Medical Director added: “The doses of encapsulated pig islet cells in this New Zealand trial are two to three times more than the initial doses in Russia and I expect to see further benefit.”
Dr John Baker, Endocrinologist at Middlemore Hospital and Clinical Director of the clinical trials unit at the Centre for Clinical Research & Effective Practice, Auckland, who will be conducting the trial said, “We have more than 200 volunteers, many of whom meet the selection criteria for this trial. They have diabetes that is difficult to control despite best efforts with their current treatment regimen."
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.
Information on its New Zealand Phase I/IIa clinical trial is available on www.ClinicalTrials.gov., a registry that is sponsored by the U.S. National Institutes of Health and provides information about clinical trials from around the world.
LCT CEO Dr Paul Tan said: “The New Zealand trial extends LCT’s clinical program and complements the clinical and commercialisation program in Russia.”
Professor Bob Elliott, LCT Founder and Medical Director added: “The doses of encapsulated pig islet cells in this New Zealand trial are two to three times more than the initial doses in Russia and I expect to see further benefit.”
Dr John Baker, Endocrinologist at Middlemore Hospital and Clinical Director of the clinical trials unit at the Centre for Clinical Research & Effective Practice, Auckland, who will be conducting the trial said, “We have more than 200 volunteers, many of whom meet the selection criteria for this trial. They have diabetes that is difficult to control despite best efforts with their current treatment regimen."
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.