« HD Researchers...Are You Paying Attention? | Main | We're Back! »
October 20, 2005
NeurotrophinCell Moving Closer to Trials
Living Cell Technologies has announced they have filed a "Pre-IND" letter requesting a meeting with the FDA. This means they are planning to conduct clincal trials for this Huntington's Disease treatment and they are ready to talk with the FDA about applying for a "Investigation New Drug" (IND) study.
This would be for their NeurophrophinCell treatment that looks promising in repairing/reversing damage in the brain caused by Huntington's Disease.
Here's the press release:
Living Cell Technologies files Pre-IND Request Letter with FDA for its NeurotrophinCell Product
ASX Announcement – 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 NeurotrophinCell product.
NeurotrophinCell (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.
Posted by Dave at October 20, 2005 09:21 PM
Trackback Pings
TrackBack URL for this entry:
http://www.huntingtons.info/MT/mt-tb.cgi/750
Comments
Post a comment
Thanks for signing in, . Now you can comment. (sign out)
(If you haven't left a comment here before, you may need to be approved by the site owner before your comment will appear. Until then, it won't appear on the entry. Thanks for waiting.)