ReNeuron Group plc has provided a trading update ahead of Annual General Meeting.
In the Company’s June preliminary results statement, we reported that recruitment had opened for the Phase II clinical trial with our ReN001 cell therapy candidate for stroke disability. We also reported that recruitment had commenced in a Phase I clinical trial of our ReN009 cell therapy candidate for critical limb ischaemia. Since then, the first patient has been dosed in both of these clinical trials.
The Phase II efficacy study with ReN001 will recruit up to 41 stroke patients at up to ten clinical sites across the UK. The dose level is 20 million CTX cells in each patient. The primary endpoint is a meaningful improvement in upper limb function in disabled stroke patients six months post-stroke to a degree that would support reimbursement of the therapy by healthcare payers on a Quality Adjusted Life Year basis. The Phase I safety study with ReN009 is a single centre dose escalation study in nine patients with lower limb ischaemia and is being conducted at Ninewells Hospital, Dundee, Scotland. In the study, three dose cohorts of three patients each will receive doses of 20 million, 50 million and 80 million CTX cells, respectively.
The Phase II clinical trial with ReN001 is on course to have generated six month follow-up data by the end of 2015. We also remain on course to announce results from the Phase I study with ReN009 in the first half of 2015.
The final pre-clinical work on ReN003, our cell therapy candidate for retinitis pigmentosa, is proceeding as planned and we remain on track to file an IND application in early 2015 to commence a Phase I/II clinical trial with ReN003 in the US.