8/15/2014 8:20:15 AM
STOCKHOLM--(BUSINESS WIRE)--Regulatory News: Enrollment to the ongoing clinical phase IIa study with NeuroVive’s (STO:NVP) drug candidate NeuroSTAT® for treating patients with severe traumatic brain injury (TBI) is continuing, and another two patients have been enrolled. 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.
Help employers find you! Check out all the jobs and post your resume.
comments powered by