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ARTICLE | Clinical News

VAS203: Final Phase IIa data

September 24, 2012 7:00 AM UTC

Final data from the double-blind, placebo-controlled, international Phase IIa NOSTRA trial in 32 patients with moderate to severe TBI showed that VAS203 plus standard of care (SOC) met the primary safety endpoint. Specifically, there were no deaths reported in the VAS203 arm compared to a mortality rate of 12.5% in the placebo arm. Additionally, vasopharm said the compound reached brain tissues in "pharmacologically relevant amounts." The company also said that TIL, a measure of concomitant therapy and physician intervention used to evaluate control of intracranial pressure, was significantly reduced in patients receiving VAS203 compared to placebo (p=0.0302). Furthermore, VAS203 significantly improved extended Glasgow Outcome Scale (eGOS) scores from baseline to 6 months post-injury vs. placebo (p=0.006). Patients received 15 mg/kg VAS203 given over 3 days, 20 mg/kg VAS203 given over 2 days or 30 mg/kg VAS203 given over 3 days. ...