Living Cell Technologies (ASX:LCT) touted data today showing its NTCell cell therapy is safe 130 weeks after treatment in a Phase I/IIa Parkinson’s trial. The study’s primary endpoint was safety.
The trial, which enrolled and treated 4 patients, involved implanting 40 NTCell capsules into 1 side of the brain. The company reported that treatment with NTCell continues to show improvement in motor function in patients with Parkinson’s disease, as measured by the Unified Parkinson’s Disease Rating Scale.
1 patient in the study elected to be treated with deep brain stimulation.
Living Cell Technologies’ NTCell is a alginate-coated capsule that contains cells sourced from a herd of pathogen-free pigs bred from stock originally discovered in the remote sub-Antarctic Auckland Islands. These neonatal porcine choroid plexus cells secrete cerebrospinal fluid and provide a range of factors that support nerve cell function and protective enzymes, according to Living Cell Technologies.
The company coats the choroid plexus cells with its Immupel technology to guard the therapy from an attack by the host’s immune system and eliminate the need for an immunosuppressive regimen.
After NTCell is implanted into a damaged site within a patient’s brain, NTCell acts as “a neurochemical factory” that produces CSF and secretes multiple nerve growth factors to promote growth and repair disease-induced nerve degeneration, according to the company. Living Cell Technologies also boasts on its website that NTCell could potentially clear away waste, including amyloids and proteins.
“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,” principal investigator Dr. Barry Snow said in prepared remarks.
“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,” CEO Ken Taylor added. “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 1st disease modifying treatment for Parkinson’s disease in 2018,” Taylor said.