10 December 2010 – Sydney, Australia, Auckland, New Zealand– Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY), a global company pioneering the development of cell implants to treat diabetes, announced today that its Russian subsidiary, LCT Biomedical Limited, has received registration of the Company’s groundbreaking diabetes treatment, DIABECELL, as a marketable medical technology in Russia. Registration allows for the sale and use of the DIABECELL technology in the treatment of Type 1 diabetes in Russia. LCT Biomedical Limited was established by LCT in 2009 to facilitate the commercial development of DIABECELL in Russia.
DIABECELL is the world’s first registered porcine cell implant therapy, administered by simple laparoscopic procedure. DIABECELL has been shown to safely reduce insulin requirements of Type 1 diabetics. In patients with unstable diabetes, DIABECELL can eliminate life threatening episodes of a potentially fatal complication known as hypoglycaemic unawareness; this is when a patient has no awareness when their blood sugar is dropping to dangerously low levels.
Dr Ross Macdonald, Chief Executive Officer of LCT said: “This is a major step toward global commercialisation of this important advancement in the treatment of diabetes, providing us with the necessary authority to commercialise DIABECELL in Russia. This registration was granted following clinical trials conducted in Russia with patients suffering from insulin dependent Type 1 diabetes. These trials demonstrated that our product safely reduces a patient’s need for insulin.”
LCT’s Russian clinical trial programme commenced in June 2007 and involved eight patients between 21 and 68 years of age with insulin-dependent diabetes. Each received between one and three implants of DIABECELL with no significant product-related adverse events. Blood samples taken from patients after a 52-week follow-up tested negative for any pig-to-human transmission of diseases. Six of the eight patients showed long-term improvements in blood glucose control as reflected by both reduction in glycated haemoglobin (HbA1c %) levels and reduction of the required daily dose of insulin injections. Two patients discontinued insulin injections entirely for about eight months. The trial was conducted in the Sklifosovsky Research Institute Moscow.
This is LCT’s first commercialisation milestone in its global strategy for DIABECELL. Meanwhile the Company is currently conducting Phase II trials in New Zealand with patients suffering from unstable Type 1 diabetes and expects to begin pivotal Phase III trials in New Zealand next year.
DIABECELL is LCT’s treatment designed to normalise the lives of people with insulin dependent diabetes. DIABECELL comprises encapsulated porcine insulin-producing cells (islets) that are implanted into the abdomen of patients using a simple laparoscopic procedure, and work by self-regulating and efficiently secreting insulin in the patient’s body. LCT's breakthrough proprietary encapsulation technology, IMMUPEL™, means that patients receiving the DIABECELL implant do not require immune suppressing drugs after implantation.
For further information: www.lctglobal.com
At the company:
Ms Susanne Clay
Chief Business Officer, Living Cell Technologies Ltd.
Tel: +64 9 270 7954
Mobile: +64 21 418 833
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About Living Cell Technologies - www.lctglobal.com
Living Cell Technologies (LCT) is developing cell-based products to treat life threatening human diseases. The Company owns a biocertified pig herd that it uses as a source of cells for treating diabetes and neurological disorders. For patients with Type 1 diabetes, the Company implants lead product DIABECELL, microencapsulated islet cells, so that near-normal blood glucose levels may be achieved without the need for administration of insulin or at significantly reduced levels. The Company entered clinical trials for its diabetes product in 2007. For the treatment of Parkinson’s disease and other neurological disorders, the company transplants microencapsulated choroid plexus cells, NTCELL, which delivers beneficial proteins and neurotrophic factors to the brain. LCT’s breakthrough microencapsulation technology, IMMUPEL, enables healthy living cells to be injected into patients to replace or repair damaged tissue without requiring the use of immunosuppressive drugs to prevent rejection. LCT also offers medical-grade porcine-derived products for the repair and replacement of damaged tissues, as well as for research and other purposes.