Date: 2013-03-26
Type of information:
phase: 1
Announcement: authorization of the trial
Company: Reneuron (UK)
Product: ReN009 stem cell therapy
Action mechanism:
Disease: critical limb ischaemia
Therapeutic area: Cardiovascular diseases
Country: UK
Trial details: Subject to local R&D site approval, the Phase I clinical trial will be undertaken through NHS Tayside at Ninewells Hospital and Medical School, Dundee, Scotland. The Principal Investigator for the study is Professor Jill Belch FRCP, MD, Institute of Cardiovascular Research, Division of Cardiovascular and Diabetic Medicine at Ninewells. In this dose escalation safety study, the ReN009 cells will be administered via straightforward intramuscular injection into the affected lower limb of nine patients with peripheral arterial disease. Approval may be sought in due course for a further clinical site in Germany to participate in the study.
Latest
news: * On March 26 2013, ReNeuron has announced that it has received regulatory and ethical approvals to commence a Phase I clinical trial in the UK with its ReN009 stem cell therapy programme targeting critical limb ischaemia (CLI). CLI represents the second major disease target after stroke for ReNeuron’s lead CTX stem cell line and is based on a number of pre-clinical studies showing dose-dependent positive effects of the CTX cells in restoring microvasculature and blood flow to the limb extremities in animal models of lower limb ischaemia. ReN009 therapy therefore offers the potential for an allogeneic (non-donor specific) and cost-effective cell-based treatment for CLI patients with the aim of restoring sufficient blood flow in the affected lower limb to avoid amputation and the severe health consequences that typically result from such an amputation.
ReNeuron recently announced that it had been awarded a Late Stage Biomedical Catalyst grant of £0.4 million from the Technology Strategy Board, the UK Government’s innovation agency, to be deployed towards the cost of the approved ReN009 Phase I study.
The Company expects recruitment and dosing of patients in the clinical trial to commence, as planned, in the middle part of this year. The straightforward nature of both the ReN009 treatment and the design of the Phase I clinical trial is expected to lead to progression into a larger placebo-controlled Phase II efficacy study during the second half of 2014, assuming the Phase I primary safety end-point is met.
