Jun 5 2013
NeuroVive Pharmaceutical AB (publ)(STO:NVP), a leading mitochondrial medicine company, has recruited the first patient in a Phase IIa clinical trial to evaluate the company´s drug candidate NeuroSTAT® for the treatment of traumatic brain injury. The trial is being conducted at the Department of Neurosurgery, Copenhagen University Hospital under the supervision of Professor Bertil Romner and Dr Walter Fischer. Bertil Romner is a leading expert in the treatment of traumatic brain injury, and Walter Fischer is the study's principal investigator.
The phase IIa trial is an open label, uncontrolled study that will recruit a total of 20 patients. The primary endpoint of the study is to evaluate NeuroSTAT®´s pharmacokinetic properties and safety in patients with severe traumatic brain injury. In addition, secondary endpoints include several monitoring techniques to study the effect of NeuroSTAT® at the mitochondrial level and how different biochemical processes are influenced by NeuroSTAT® after a brain injury has occurred.
Traumatic brain injury is an area of huge medical need for which there are currently no approved pharmaceutical treatment options.
Mikael Brönnegård, CEO of NeuroVive Pharmaceutical said: "The inclusion of the first patient in our phase IIa trial to evaluate NeuroSTAT® for traumatic brain injury is an important milestone for NeuroVive. The study is designed to generate safety data and dosage information for the treatment of traumatic brain injury. This data will be vital for the upcoming phase III study with the purpose of evaluating NeuroSTAT®´s treatment potential for traumatic brain injury. The design work and planning of the phase III study have already begun."
Bertil Romner, Professor of Neurosurgery, added: "I am glad to take part in the development of a long-awaited pharmacological treatment for patients suffering from traumatic brain injury, a disease with highly unmet medical need."
SOURCE NeuroVive Pharmaceutical AB
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