6 July 2009: Sydney, Australia, Auckland, New Zealand– Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced the formation of a subsidiary, LCT Biomedical Limited (Russia), to facilitate the commercial development of DIABECELL®, its lead product for the treatment of type 1 diabetes.
Natalia Dolgova, who is based in Moscow, has been appointed the first director of LCT Biomedical.
Mrs. Dolgova has 17 years experience in the medical products market in Russia. Her objectives are to obtain regulatory approval for a pivotal clinical study of DIABECELL® in at least two centres in Russia and register the product so that the treatment is available for people with diabetes in Russia.
Dr Olga Garkavenko, LCT’s New Zealand based Regional Director for Russia said, “The regulatory process has already been initiated and it is envisaged that the pivotal study and product would be registrable by October 2011.”
Prof Bob Elliott, Medical Director of LCT, said, “This subsidiary is a timely development to advance positive preliminary results from the first trial in Moscow. We have now implanted 8 patients with DIABECELL®, the most recent on 22 June 2009 in a 33 year old man with type 1 diabetes. To date, there have been no untoward adverse events. Two patients remain off insulin injections at their last clinical review. All patients followed up have said they are pleased with how the implants have improved control of their blood sugar levels and this is supported by their normalized %HbA1c (glycated hemoglobin measurements) and reduced daily insulin doses.”
Dr Paul Tan CEO LCT said, “The establishment of this company with local business and regulatory expertise aims to accelerate commercial development. DIABECELL® will be supplied from New Zealand for the foreseeable future. This is the quickest development pathway to get this innovative treatment available to the wider diabetic community.”
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.
