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Reneuron Group (LON:RQE) has announced the publication of long-term Phase I stroke clinical trial (PISCES-I) data in The Lancet. The data indicate improvements in neurological status and limb function compared with pre-treatment baseline performance within three months of treatment and throughout long-term follow up. Alongside this there were no cell-related or immunological adverse events across the four ascending dose levels in the study. This is positive as the data from the first stroke study continue to demonstrate safety, tolerability and functional improvement from the CTX cell therapy treatment. Investor focus is currently on the three-month readout of ReNeuron’s Phase II stroke disability study (PISCES-II) with its CTX cells, due in Q416. We maintain our rNPV at £249m.
Long-term Phase I data published – PISCES-I study
PISCES was a Phase I study, which treated 11 stroke-disabled patients with a range of doses of CTX cells (2m, 5m, 10m, 20m) injected into the damaged area of the brain. On safety, no cell-related or immunological adverse events were reported. In terms of treatment benefit, three out of 11 patients (~25%) had a one-point improvement after 24 months in the modified Rankin Score, regarded as clinically meaningful. Median NIHSS improved by two points, from 7 at baseline to 5 after 24 months (p=0.002). Please click here to read the Lancet publication.
To read the entire report Please click on the pdf File Below
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