7 June 2016
Sydney, Australia & Auckland, New Zealand
81 weeks after treatment all four patients who took part in Living Cell Technologies Limited's Phase I/IIa clinical study of NTCELL® for Parkinson's disease show reversal of the progression of Parkinson's disease as measured by globally accepted and validated Unified Parkinson's Disease Rating Scale (UPDRS).
As the chart below shows, after 81 weeks there is a clinically and statistically significant improvement in the patients' neurological scores from their pre-implant baseline.
Parkinson's disease progression is measured by a neurological rating scale, UPDRS. The UPDRS score increases by approximately 4 to 5 points each year as Parkinson's disease progresses.
NTCELL's ability to decrease UPDRS by an average of 14 points after 81 weeks is clinically significant, representing a 2.8 to 3.5 year reversal of neurological deterioration. In the first patient the improvement is sustained at 130 weeks after NTCELL implant.
All four patients remain well and there are no safety concerns.
This data will be presented at the 20th International Congress of Parkinson's Disease and Movement Disorders in Berlin 19-23 June, by the Principal Investigator Dr Barry Snow, entitled "Safety and clinical effects of NTCELL® [immunoprotected (alginate-encapsulated) porcine choroid plexus cells for xenotransplantation] in patients with Parkinson's disease (PD): 81 to 130 weeks follow-up".
Dr Ken Taylor, CEO of LCT, says the continued positive outcome of the study gives LCT confidence as the company looks forward to the results of the larger Phase IIb study initiated this year.
"This second study aims to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson's disease patient sub group.
"Our goal, subject to continued satisfactory data, is to obtain provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson's disease in 2017," says Dr Taylor
- Ends - For further information: www.lctglobal.com
| At the Company: Ken Taylor Chief Executive Tel: +64 9 276 2690 Mobile: +64 21 796 000 ktaylor@lctglobal.com | Media Contact: Rachael Joel Botica Butler Raudon Partners Tel: +64 9 303 3862 Mobile: +64 21 403 504 rachaelj@botica.co.nz | |
NTCELL, a unique cell therapy, is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells that are sourced from a unique herd of designated pathogen-free pigs bred from stock originally discovered in the remote sub-Antarctic Auckland Islands. Choroid plexus cells are naturally occurring "support" cells for the brain and secrete cerebrospinal fluid (CSF), which contains a range of factors that support nerve cell functions and protective enzymes that are crucial for nerve growth and healthy functioning. In NTCELL, the porcine choroid plexus cells are coated with LCT's propriety technology IMMUPEL™ to protect them from attack by the immune system. Therefore, no immunosuppressive regimen is required for treatment.
Following implantation into a damaged site within the brain, NTCELL functions as a neurochemical factory producing CSF and secreting multiple nerve growth factors that promote new central nervous system (CNS) growth and repair disease-induced nerve degeneration while potentially removing waste products such as amyloids and proteins.
LCT has global patents pending entitled "Treatment of CNS disease with encapsulated inducible choroid plexus cells". LCT also has gene chip analysis of NTCELL identifying multiple growth and trophic factors, antioxidants, chaperone molecules and other bioactive components.
NTCELL has the potential to treat neurodegenerative diseases because choroid plexus cells help produce CSF as well as a range of neurotrophins (nerve growth factors) that have been shown to protect against neuron (nerve) cell death in animal models of disease. NTCELL has been shown in preclinical studies to regenerate damaged tissue and restore function in animal models of Parkinson's disease, stroke, Huntington's disease, hearing loss and other non-neurological conditions, such as wound healing. In addition to Parkinson's disease, NTCELL has the potential to be used in a number of other CNS indications, including Huntington's, Alzheimer's and motor neurone diseases including amyotrophic lateral sclerosis (ALS).
About Parkinson's disease
Parkinson's disease is a progressive neurological condition characterised by a loss of brain cells that produce dopamine (a neurotransmitter that conveys messages between brain cells to ensure effective movement and planning of movement) and many other types of neurons. People with Parkinson's disease experience reduced and slow movement (hypokinesia and bradykinesia), rigidity and tremors.
Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease, affecting approximately 7 million people worldwide. The average age of onset is 60 years, and the incidence increases with age. Men are one and a half times more likely to have Parkinson's disease than women.
Current treatments for Parkinson's disease are symptomatic and do not reverse or slow the degeneration of neurons in the brain. Most existing pharmaceutical treatment options focus on restoring the balance of dopamine and other neurotransmitters. The effectiveness of dopamine replacement therapy declines as the disease progresses. When dopamine treatments are no longer useful, some patients are treated with Deep Brain Stimulation (DBS), in which a medical device is surgically implanted in the brain in order to send electrical impulses to regions of the brain involved in the control of movement. While DBS leads to short-term symptomatic improvement, it does not impact disease progression and is not curative or neuroprotective.
http://health.einnews.com/article/329722253/-3jfs4e1-fv-Od9t
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