LCT files for pre-IND meeting with FDA
Thursday, 20 October, 2005
Living Cell Technologies (ASX:LCT) has filed a request for a pre-IND meeting with the US FDA to seek guidance and feedback on the development program for its NeurotrophinCell (NtCell) product for the treatment of Huntington's disease.
"We intend to undertake phase I clinical trials in the US next year," said LCT managing director Paul Tan. "A detailed timeframe depends on the discussions with the FDA at the pre-IND meeting."
NtCell is an injectable live cell product which 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.
NtCell's first indication is for the treatment of people with Huntington's disease which currently has no cure or treatment. Effecting more than 1 in 100,000 people it is an inherited disease which progresses rapidly with dementia and progressive movement difficulties.
The biocapsules act as an immune barrier, allowing for the cocktail of hormones to leave the capsule, but prevent the body's immune system from rejecting the cells. The biocapsule cell treatment is administered intracranially through a catheter into the striatum, the region of the brain predominantly affected by Huntington's disease.
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