UK-based stem-cell pioneer ReNeuron says it is on track to seek approval for a Phase II clinical trial of its ReN001 therapy in disabled stroke patients “during the course of next year”.
ReNeuron was also the first company to secure regulatory approval for any stem cell-based clinical trial in the UK.
It announced in November 2010 that the first patient in the Phase I PISCES (Pilot Investigation of Stem Cells in Stroke) study of ReN001, which is based on multipotent somatic stem cells taken from non-embryonic human tissue, had been treated at the Institute of Neurological Sciences at Southern General Hospital in Glasgow, Scotland.
ReNeuron has now signed a new cell-manufacturing contract with its partner Angel Biotechnology Holdings, which will provide the materials for the remaining part of the PISCES Phase I trial. The final patient in the second dose cohort of the PISCES study was treated last month as scheduled, ReNeuron noted.
The investigative site in Glasgow has also identified potentially eligible patients for all of the remaining two dose cohorts in the study, it added. Two further UK sites are “in the process of being approved to recruit patients into the PISCES study, should this be necessary to meet recruitment targets”.
The expectation is that the additional sites will also take part in a Phase II clinical trial of ReN001 in due course.
On track for Phase IISubject to a “continuing lack” of cell-related adverse events and affirmative advice from the study’s Data Safety Monitoring Board, the remaining dose cohorts in the PISCES trial should be treated within the next twelve months.
This would leave ReNeuron “on track to submit an application for a Phase II clinical study with ReN001 during the course of next year”, it said.