Living Cell Technologies (ASX: LCT) (OTCQX: LVCLY) has received approval from the Northern A Health and Disability Ethics Committee for the Phase IIb clinical trial of NTCELL® for Parkinson’s disease. The New Zealand Minister of Health authorised the application to conduct the trial on 12 November 2015.
The Phase IIb trial follows the successful Phase I/IIa trial, which showed excellent safety data and clinically and statistically significant efficacy data in patients with Parkinson’s disease one year after NTCELL treatment.
The Phase IIb trial 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. The company plans to initiate the trial on 24 February 2016.
If the trial is successful the company will apply for provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson’s disease in 2017.
For further information: www.lctglobal.com
About Living Cell Technologies
Living Cell Technologies Limited (LCT) is an Australasian biotechnology company improving the wellbeing of people with serious diseases worldwide by discovering, developing and commercialising regenerative treatments which restore function using naturally occurring cells.
LCT’s lead product, NTCELL®, is an alginate coated capsule containing clusters of neonatal porcine choroid plexus cells. After transplantation NTCELL functions as a biological factory, producing factors to promote new central nervous system growth and repair disease-induced nerve degeneration.
The Phase I/IIa NTCELL clinical trial in New Zealand for the treatment of Parkinson’s disease met the primary endpoint of safety and showed encouraging clinical efficacy improvements. Results from this trial have been used to design a larger Phase IIb trial to evaluate its potential as a disease-modifying treatment for patients with Parkinson’s disease. It has the potential to be used in a number of other central nervous system indications such as Huntington’s, Alzheimer’s and motor neurone diseases.
LCT’s proprietary encapsulation technology, IMMUPEL™, allows cell therapies to be used without the need for co-treatment with drugs that suppress the immune system.
LCT is listed on the Australian (ASX: LCT) and US (OTCQX: LVCLY) stock exchanges. The company is incorporated in Australia, with its operations based in New Zealand.