ReNeuron Group plc has signed two further clinical-grade stem cell manufacturing contracts with Angel Biotechnology Holdings plc (Angel), in support of ReNeuron’s recently approved first-in-man clinical trial with its ReN001 stem cell therapy for stroke patients. Under these contracts, Angel will manufacture further drug substance lots of ReN001 for administration to patients in the trial, along with the provision of manufacturing process validation services. The cost of the drug product manufacture is being met by a recently-awarded grant from the UK Government's Technology Strategy Board, under its Regenerative Medicine Programme.
The "PISCES" clinical trial (Pilot Investigation of Stem Cells in Stroke) will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In this ground-breaking Phase I trial, the world’s first using expanded neural stem cells in this indication, ReNeuron’s ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial.
Michael Hunt, chief executive officer of ReNeuron, said, "We are pleased to continue to work with Angel as our chosen contract manufacturing partner for the PISCES clinical trial for ReN001 in stroke. Angel has consistently demonstrated its strong expertise in the field of regulatory-compliant cell manufacture, meeting ReNeuron’s needs for this important first-in-man study."
Angel Biotechnology Holdings plc is a biomanufacturing company offering process development services, GMP manufacturing for advanced biologics and regulatory support including preparation of dossiers for regulatory submissions.
ReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.