UK-based stem cell researcher ReNeuron has signed a cell manufacturing contract with Angel Biotechnology Holdings, which will provide materials for the remaining part of an early-stage clinical trial of ReN001 therapy to treat disabled stroke patients.
The final patient in the second dose cohort of the PISCES (Pilot Investigation of Stem Cells in Stroke) study was treated in April 2012, as scheduled, and the ReNeuron is now on track to seek approval for a Phase 2 clinical trial during the course of next year.
The clinical site, based in Glasgow, Scotland, has identified eligible patients for all remaining two dose cohorts in the study and two more UK sites are in the process of being approved to recruit new participants, should ReNeuron meet recruitment targets.
ReNeuron CEO Michael Hunt said: "We are pleased to continue our manufacturing partnership with Angel to serve the needs of the ongoing PISCES stroke clinical trial and we look forward to seeing the higher dose cohorts in the study treated with our ReN001 stem cell therapy over the coming months."
Angel Biotechnology acting CEO Dr Stewart White also commented: "Angel is very proud to be providing ReNeuron with additional manufacturing support to complete this ground-breaking Phase 1 clinical trial."
"This contract is further recognition of the strong partnership between Angel and ReNeuron and also reaffirms both companies’ commitment to provide solutions for a real clinical need," White added.
ReNeuron was 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 1 PISCES 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.