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news.Enrollment to the ongoing clinical phase IIa study with NeuroVive’s (NVP.ST) drug candidate NeuroSTAT for treating patients with severe traumatic brain injury (TBI) is continuing, and another two patients have been enrolled.
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Accordingly, at present, seven of a total of 20 patients have been enrolled in the study. The enrollment of new patients to the study has taken somewhat longer time than scheduled, but NeuroVive assumes that the ten patients to be treated with a lower dose will have been enrolled by year-end, or during Q1 2015 at the latest.
Subsequently, the plan is to conduct interim analysis of data from these first ten patients with the aim of forming an opinion of treatment safety.
If there are no safety concerns, the objective is for another ten patients to be enrolled during 2015 with treatment at a higher dose. In addition to planned interim analysis, continuous assessment treatment safety is being conducted.
Based on safety assessments of the first patients, treatment with NeuroSTAT at the lower dose is considered to be safe and patient enrollment is continuing as planned.
This phase IIa study is an open, non-comparative study involving a total number of 20 patients. Its primary endpoint is to evaluate NeuroSTAT’s pharmacokinetics* and safety in TBI.
Secondly, a number of measurements will be conducted, firstly to study NeuroSTAT’s efficacy at the mitochondrial level, and to study how biochemical processes are affected by NeuroSTAT post-TBI. TBI is a segment subject to a major medical need, where there are no registered pharmaceutical therapies at present.