LIVING CELL TECHNOLOGIES FILES PRE-IND REQUEST LETTER WITH FDA

Living Cell Technologies (LCT) has filed a request for a pre-IND (investigational new drug application) meeting with the FDA to seek guidance and feedback on the development program for its NeurotrophinCell (NtCell) product.

NtCell is LCT's injectable live cell product being developed for the treatment of patients with neurodegenerative diseases. The product is manufactured by LCT using natural porcine cells that are encased in a biopolymer 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, a neurological disease that currently has no cure or treatment.