Phase IIb Parkinson's trial approved

Biotechnology company Living Cell Technologies (ASX:LCT) has received approval from the Auckland Hospital Research Review Committee for its Phase IIb clinical trial of NTCELL for Parkinson’s disease.

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.

In January, LCT reported successful results for its Phase I/IIa trial of NTCELL, which saw the treatment meet the primary endpoint of safety and showed clinically and statistically significant efficacy data in patients with Parkinson’s disease one year on, including an improvement in all patients’ neurological scores.

The Phase IIb trial follows on from this trial and 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 subgroup. The New Zealand Minister of Health authorised the application to conduct the trial on 12 November 2015 and the Northern A Health and Disability Ethics Committee gave its approval on 3 February 2016.

Patient recruitment for the Phase IIb trial is underway. If the trial is successful, the company will apply for provisional consent to treat paying patients in New Zealand and launch NTCELL as the first disease-modifying treatment for Parkinson’s disease in 2017.

Living Cell Technologies (ASX:LCT) shares were trading unchanged at $0.05 as of around 11 am on Thursday.