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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 09:21 PM | Comments (0) | TrackBack
October 15, 2005
HD Researchers...Are You Paying Attention?
Turmeric, the Asian spice that makes curry yellow, not to mention French's mustard and Hindu priests' robes, has yet another life: It's a promising potential weapon against several cancers, Alzheimer's, cystic fibrosis, psoriasis and other diseases....At least a dozen clinical trials on humans are under way in the United States, Israel and England to test the safety and dosages of turmeric's main ingredient, curcumin...
The spice, which is a relative of ginger, comes from the stems of the root of a large-leafed plant widely grown in Asia, especially in the province of Maharashtra in southwest India. The stems are boiled, dried and crushed to a powder with a bitter woody taste that's widely used as a spice and in folk medicines to cure stomach ailments and skin lesions...
It's been demonstrated in animals to protect the liver, inhibit tumors, reduce inflammation and fight some infections. Curcumin has both antioxidant and anti-inflammatory properties, according to researchers, and may help lower cholesterol.
And the kicker...
A report in the Journal of Biological Chemistry in December found that in mice injected with a chemical that mimics Alzheimer's, curcumin reduced by half the buildup of knots in the brain called amyloid plaques, which have been linked to Alzheimer's.
Some one is (though I'm not finding studies that have been published):
Yet in another separate study, Marie-Francoise Chesselet, chair of the department of neurobiology at the David Geffen School of Medicine and Miriam Hickey, a postgraduate researcher, is studying the effects of curcumin on Huntington's Disease.Huntington's Disease is characterized by an abnormal genetic mechanism which results in accumulation of the Huntington protein similar to the build-up of beta amyloids in Alzheimer's Disease.
"We found that if we give curcumin to mice they will have less aggregate in their brains, but we don't know yet if that will improve symptoms," Chesselet said.
Since curcumin acts as an antioxidant, it can be additionally beneficial to those with Huntington's Disease.
"It is also safe because people can ingest a lot of curcumin and it's not bad for them," Chesselet said.
"The advantage is that it can be given in the food without being injected," she added.
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October 06, 2005
Prozac Protective Against HD?
Melbourne, Australia, scientists say they've found Prozac not only helps depression caused by Huntington's disease, but also improves learning and memory.The researchers at the Howard Florey Institute, led by Dr Anthony Hannan, also found fluoxetine, the drug contained in Prozac, restores the brain's process of neurogenesis -- the birth of new neurons -- to normal levels, which delays the onset of the inherited fatal disease.
...Now that we've found fluoxetine improves memory problems, or dementia, as well as depression in mice with Huntington's disease, further research can be conducted to see if the drug has the same benefits in humans with the disease, Hannan said.
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