WUERZBURG, Germany, September 17, 2012
VAS203 demonstrates potential as safe and effective treatment
vasopharm GmbH, a pharmaceutical company dedicated to the discovery and development of novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announces that the explorative phase IIa NOSTRA trial in Traumatic Brain Injury Patients met all clinical endpoints for safety and in addition demonstrated strong evidence of clinical benefit in patients.
Traumatic Brain Injury is caused when an external force impacts the head. It is a condition with high unmet medical need and is the leading cause of death and disability among young adults in the developed world. TBI accounts for more potential years of life lost than cancer and cardiovascular disease combined and there are currently no drugs available to treat this condition.
The NOSTRA (NO-Synthase inhibition in TRAumatic brain injury) trial was a European, multicentre, placebo-controlled, double blind study with safety and tolerability as primary endpoints. The study employed 'in vivo' microdialysis to monitor pharmacodynamic and pharmacokinetic properties of the compound VAS203. VAS203 is a novel allosteric NO-synthase antagonist which interrupts the inducible nitric oxide process involved in brain swelling.
In total, 32 patients with moderate to severe traumatic brain injury were enrolled in three cohorts in six study centres in Spain, England, Austria, France and Switzerland. All study centres used continuous microdialysis to monitor cerebral energy household, NO metabolism and concentration of the drug in the brain tissue. VAS203 was administered in addition to standard of care treatment.
PR Newswire