Vasopharm Provides Update on Phase III Traumatic Brain Injury Trial
50% of patients enrolled in trial triggers interim data review
vasopharm GmbH, a privately held biopharmaceutical company, today announced that it has recruited half of the 220 patients in the ongoing, pivotal European NOSTRA III (NO Synthase in TRAumatic Brain Injury) clinical trial. This milestone triggers an interim review by the Data Monitoring Committee (DMC) in line with the agreed study protocol. Allowing for the six month extended Glasgow Outcome Scale (eGOS) evaluation for the 110th eligible patient recruited, the company expect feedback from the DMC in Q4 2018.
NOSTRA III is a randomised, double-blind, placebo-controlled trial. The study will enroll 220 patients who have suffered a moderate to severe TBI resulting in hospitalisation and who have received an intra-cranial pressure probe. Currently, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain are participating. The primary endpoint is the eGOS evaluated at six months after the injury. Secondary efficacy assessments include Quality of Life (QOLIBRI) as well as Therapy Intensity Level (TIL) over 14 days after brain injury.
Christian Wandersee, Chief Executive Officer of Vasopharm, commented:
“We are delighted to have reached such a significant milestone in the development of Ronopterin for the treatment for moderate to severe TBI. If NOSTRA III confirms the highly significant data seen in our NOSTRA II trial, we believe we can offer patients and physicians a therapeutic option to ameliorate the devastating and life-long consequences of TBI, where no such option currently exists.”back