ASX-listed Kiwi biotech firm Living Cell Technologies won't seek provisional consent for its treatment for Parkinson's disease after the latest trial did not show a "statistically significant difference" between people who received the treatment and those who didn't.
The Melbourne-based company halted trading of its shares yesterday ahead of the trial's results, which it was hoping would give it the all-clear to pursue commercial sales of its treatment as early as next year.
"More data analysis and input from our advisers is required but at this time we cannot proceed with a regulatory application," chief executive Ken Taylor said in a statement to the ASX.
Living Cell developed the NTCELL treatment for Parkinson's disease using choroid plexus brain cells from neonatal pigs, which are implanted into a damaged site in the brain and then function as a "neurochemical factory" producing factors that promote new central nervous system growth and repair disease-induced nerve degeneration.
The cell therapy had shown potential in early trials as a disease-modifying agent in Parkinson's disease.
The latest study was designed 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 biotech firm's Phase IIb clinical trial was completed in April and it had been waiting for the results to be unblinded,
There were three groups of six patients and two patients from each group had sham surgery with no NTCELL implanted, to act as a control.
The remaining patients received different numbers of microcapsules of NTCELL on each side of the brain.
While no product or procedure adverse events occurred and there is no evidence of xenogeneic infection in patients and their partners "we are disappointed that the efficacy primary endpoint has not been met," said Taylor.
Principal investigator Barry Snow at Auckland City Hospital said the next step is to analyse the data in depth and continue to monitor patients in accord with the study extension protocol, particularly for the efficacy movements at longer time points.
The ASX-listed shares last traded at 20.5 Australian cents and have risen 130 percent so far this year.