NeuroVive and EBIC Sign TBI Clinical Trial Collaboration
Product News Mar 04, 2011
NeuroVive announces that it has signed an agreement with the European Brain Injury Consortium (EBIC) to conduct a European multi-center Phase II/III clinical trial of NeuroSTAT® for neuroprotection in patients with traumatic brain injury (TBI).
The goal of the collaboration is to secure the highest possible study quality and compliance with clinical standards to support NeuroSTAT®'s rapid progress toward commercialization. To this end, NeuroVive will work closely with EBIC's key European experts in the field of neurotrauma and acute brain injuries.
NeuroVive will manage the study in close collaboration with the EBIC group and a clinical research organization (CRO) to be selected. The collaboration with EBIC includes development of the study protocol, site selection, patient recruitment, and statistical support. This adaptive design Phase II/III study will determine the safety and efficacy of NeuroSTAT® in moderate to severe TBI.
TBI is a leading cause of death and disability among a predominantly young male population, mostly victims of motor vehicle accidents. TBI is composed of two stages: a first stage of initial brain damage; and a second stage of mitochondrial collapse inside brain cells leading to additional cell death, brain damage and disability.
The active agent in the NeuroSTAT® formula is a proven mitochondrial protector that in animal studies is a potent neuroprotectant against TBI. There are over 10 million TBI cases per year worldwide. Annually in the U.S., head trauma sends two million people to the emergency room and a half a million have injuries severe enough to be admitted to the hospital.
TBI kills 50,000 people and leaves 80,000 people disabled. The annual market for an effective TBI drug is estimated to exceed US$1 billion in the U.S. and Europe.
NeuroVive CEO Mikael Bronnegard comments: "We are very pleased to collaborate on the NeuroSTAT® Phase II/III clinical trial with a highly respected organization like EBIC, comprising key opinion leaders and medical experts in the field of neurotrauma in Europe. Through this collaboration, we have an excellent opportunity to advance the development of NeuroSTAT® toward clinical use in treating millions of TBI patients worldwide."
Professor Andrew Maas, Chairman of EBIC, Professor and Chairman Department of Neurosurgery at University Hospital Antwerp, Belgium comments: "This clinical trial is of great interest to us. The need for international collaboration in the conduct of research in the clinical management of head injury has never been greater, but rigorous evaluation must be carried out on a range of approaches that include new pharmacological agents. Therefore, the collaboration with NeuroVive in conducting a clinical trial in TBI patients with their product NeuroSTAT® offers a unique way to address all critical issues in study design, selection of end-points, patient recruitment, study monitoring and, finally, study analysis."