SYDNEY & AUCKLAND, New Zealand--(BUSINESS WIRE)--130 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 remain well and there are no safety concerns. The primary clinical endpoint of this initial open clinical study, involving the implantation of 40 NTCELL capsules into the putamen on one side of the brain only, is safety.
In all patients NTCELL treatment continues to show improvement over baseline, as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). Efficacy is most evident in the measurement of motor function (UPDRS part III subscale – see chart here).
During follow up in this clinical study patients have the right to request implantation on the other side of the brain, continue as is, or elect to have deep brain stimulation (DBS). One patient has elected to be treated with DBS.
The Principal Investigator, Dr Barry Snow, Auckland City Hospital, says the sustained improvement is interesting and encouraging.
“The results to date certainly validate the Phase IIb dose ranging study in progress, in which higher doses of NTCELL are implanted into the putamen on both sides of the brain and which includes a sham surgical-controlled placebo group.”
Dr Ken Taylor, CEO of LCT, says, “As this initial trial of a low dose of NTCELL was designed to measure safety, we are happy that the primary endpoint continues to be met. We are looking forward to the results of the larger Phase IIb study initiated this year which is designed to measure efficacy. This study will 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, remains to obtain provisional consent and launch NTCELL as the first disease modifying treatment for Parkinson’s disease in 2018,” says Dr Taylor.
For further information: www.lctglobal.com