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20 October, 2005 - Melbourne, Australia: Living Cell Technologies Limited (ASX: LCT) today announced that it has filed a request for a Pre-IND Meeting with the FDA to seek guidance and feedback on the development program for its NeurotrophinCellÒ product. NeurotrophinCellÒ (NtCell) is LCT’s injectable live cell product being developed for the treatment of patients with neurodegenerative diseases. NtCell is manufactured by LCT using natural porcine cells that are encased in a bio-polymer capsule developed from seaweed. The cells used are choroid plexus brain cells, which produce spinal cord fluid and a range of neurotrophins or growth factors, for the repair and function of the brain. The biocapsules act as an immune barrier, allowing for the cocktail of hormones to leave the capsule, but preventing the body’s immune system from rejecting the cells. No immunosuppression is required in the treatment. LCT’s first targeted application of NtCell is Huntington’s disease. Huntington’s disease is a devastating neurological disease that currently has no cure or treatment. It is an inherited disease that progresses rapidly with dementia and progressive movement difficulties. More than 1 in 100,000 people are affected by HD. Genetic screening can identify individuals that will ultimately suffer from HD. The biocapsule cell treatment is administered intracranially through a catheter into the region of the brain predominantly affected by HD, known as the striatum. “Our goal is to make sure that we have addressed all of the requirements outlined in the FDA’s Guideline on Xenotransplantation Products and other relevant guidance,” said Mr David Collinson, LCT’s Chief Executive Officer. “The Pre-IND letter and associated information summary for NtCell represents a significant milestone for LCT. It indicates that LCT is on track with its goals and milestones.” Huntington’s disease currently has an annual cost to US healthcare at over US$2.5billion. NtCell has the potential to meet a $700m market opportunity.
About Living Cell Technologies: www.lctglobal.com Living Cell Technologies Ltd (ASX: LCT) develop live cell therapy products to treat life threatening human diseases. The ASX listed, vertically integrated company operates globally through offices in Australia, New Zealand and the United States. LCT focuses on developing treatments where healthy living cells are injected into patients to replace or repair damaged tissue, without requiring the use of toxic drugs to prevent rejection. The company’s product portfolio focuses on treatments for people with Huntington’s disease, insulin-dependent diabetes and haemophilia. In pre-clinical models, NtCell protects brain tissue that would otherwise die and has the potential to forestall or prevent the consequences of neurodegenerative disease. LCT will evaluate the possibility this treatment approach may also be used effectively in disorders such as stroke, Lou Gehrig’s disease, Alzheimer’s and Parkinson’s disease. Living Cell Technologies Ltd
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