Living Cell requests FDA meeting on Huntington's treatment

By E. Janene Geiss

Philadelphia, Oct. 20 - Living Cell Technologies Ltd. announced Thursday that it has filed a request with the U.S. Federal Drug Administration for a meeting to seek guidance and feedback on its NeurotrophinCell development program for neurodegenerative diseases.

In a company news release, officials said they requested the pre-investigational new drug application (pre-IND) meeting because they want to make sure they have addressed all of the requirements outlined in the FDA's Guideline on Xenotransplantation Products and other relevant guidance.

NeurotrophinCell (Ntcell) is an injectable live-cell product being developed for neurodegenerative diseases, the first application being Huntington's disease. It is manufactured by Living Cell Technologies using natural porcine cells that are encased in a bio-polymer capsule developed from seaweed. The cells used are choroid plexus brain cells, which develop spinal cord fluid and a range of neurotrophins or growth factors for the repair and function of the brain, officials said.

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 immunosupression is required in the treatment, officials said.

The biocapsule cell treatment is administered intracranically through a catheter into the region of the brain predominantly affected by Huntington's disease, which currently costs the U.S. health care industry more than $2.5 billion.

Officials said NtCell has the potential to meet a $700 million market opportunity.

"The pre-IND letter and associated information summary for NtCell represents a significant milestone for [Living Cell]. It indicates that [Living Cell] is on track with its goals and milestones," said David Collinson, chief executive officer.

Hawthorn, Victoria, Australia-based Living Cell Technologies develops live cell therapy products to treat Huntington's disease, insulin-dependent diabetes and hemophilia.

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