ReN001: Phase I data

Interim data from 5 patients with moderate to severe functional neurological impairments resulting from stroke in the open-label, dose-escalation, U.K. Phase I PISCES trial showed that single doses of intracranial ReN001 led to no cell-related adverse events or adverse immune-related responses at 3 (n=2), 6 (n=1) or 12 months (n=2) post-treatment. There were minor procedure-related adverse events, including asymptomatic bleeds and superficial scalp infections at the implantation site. Additionally, ReN001 improved neurological deficits, as measured by a reduction in National Institutes of Health Stroke Scale (NIHSS) scores, with a median score of 4 points at 3 months post-treatment vs. 8 points at baseline. Furthermore, ReN001 improved spasticity, as measured by a reduction in Summated Ashworth Scale for affected upper and lower limbs scores, with a mean score of 21.8 points at 3 months post-treatment vs. 28.6 points at baseline. PISCES is designed to evaluate 2 million, 5 million, 10 million or 20 million cell doses of ReN001 given 6-24 months after a stroke in 12 patients. Data were presented at the International Society for Stem Cell Research meeting in Yokohama. ...