RE: Do you believeβ¦28 Sep 2021 14:44
Hi hopefulmast
You are missing the 'Update for hRPC therapy candidate study' in June this year explaining that one patient had experienced an eye infection in the treated eye 5 days after the injection. At that time the enrolment was put on hold.
On the 8th July we were told,
'hRPC stem cell therapy candidate for retinal disease:
Β· Efficacy signal seen in phase 2a subjects reaching 12 months follow up with some variability of response seen between subjects
Β· Regulatory approval has been received for the expanded Phase 2a study in US, UK and Spain. This Phase 2a extension study incorporates a doubling of the previous dose, which with other study elements was designed to build on the efficacy signal seen in the earlier cohorts of the study whilst trying to remove some of the variability
Β· Four out of the nine additional subjects have been treated to date but a presumed case of bacterial endophthalmitis led to precautionary temporary study enrolment suspension; however, following a completed investigation, and with Data & Safety Monitoring Board approval, the study has reopened to enrolment in the US with amendments being filed to reopen in the UK and Spain
Β· Three-month data from extension segment of Phase 2a study to be available in Q4 2021'
We reach Q4 on Friday so an update is possible during October.
Chester.