Phase I Trial Of NTCELL® In Parkinson's Disease Authorized In New Zealand

Date: Oct-08-2012The New Zealand Minister of Health has authorized Living Cell Technologies Limited to proceed with Phase I clinical trials of NTCELL for the treatment of Parkinson's disease.

The company says it is on track to start its first in-human trials in the first quarter of 2013. The Phase I open label investigation on the safety and efficacy of NTCELL in patients with Parkinson's disease will last 60 weeks and will include only those who were diagnosed with Parkinson's disease (PD) at least four years ago.

In the Trial, Auckland Island pigs' choroid plexus cells will be transplanted into the patient's brains. Choroid plexus cells are naturally-occurring support cells of the brain. When they are transplanted into Parkinson's disease patients they help protect the brain from nerve tissue damage. Choroid plexus cells also help repair damaged nerve tissue. In order to prevent the immune system from rejecting them, the cells will be encapsulated with IMMUPEL.

Trial participants will either receive current gold standard of treatment for their symptoms (deep brain stimulation) or NTCELL treatment.

The trial will be led by Dr Barry Snow (MBChB, FRACP, FRCPC), an internationally recognized Parkinson's disease expert.

Dr. Snow said:

"Parkinson's is a disorder which clinicians can help manage but can't reverse, so this
represents an exciting new potential option for patients. These clinical trials
will also help raise public awareness of the disorder, which in turn helps improve the way
the disorder is looked after generally."

Dr Andrea Grant, Chief Executive of LCT, said "Receiving regulatory approval to conduct clinical trials is a critical step in developing a treatment for this debilitating condition. The unprecedented results of our preclinical studies suggest that NTCELL can protect brain tissue which would otherwise die, potentially delaying or even preventing the effects of Parkinson's."

According to animal studies with NTCELL:
there was an increase in dopamine-producing neurons

there were better motor movements

there were fewer neurological defects

the animals tolerated the drug well, there was no evidence of inflammation or other side effects

improvements in PD symptoms were observed within two weeks and lasted for at least six months
About Parkinson's disease
Alzheimer's disease is the most common neurodegenerative disorder, followed by Parkinson's disease (PD). PD affects between four to six million people globally. The disease is caused by reduced levels of dopamine in the brain, which leads to motor and coordination problems, including tremor, rigidity, and bradykinesia (slowness of movement). Later on, as the disease progresses, there are also cognitive and behavioral problems.

Current treatments - focusing on slowing down the drop in dopamine levels and alleviating some of the symptoms - work well initially, but become less effective as the disease advances.

Living Cell Technologies Limited believe their experimental drug will do more than simply treat the symptoms; it is expected to be able to reverse the degeneration of the brain.

Written by Christian Nordqvist

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