Continuation of NOSTRA trial with 2nd cohort
vasopharm announced the receipt of the recommendation letter of an independent Drug Monitoring Committee to proceed with its clinical phase IIa NOSTRA trial
vasopharm GmbH, a pharmaceutical company dedicated to the discovery and development of novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the receipt of the recommendation letter of an independent Drug Monitoring Committee to proceed with its clinical phase IIa NOSTRA trial (NO-Synthase inhibition in TRAumatic brain injury).
Recruitment of the first open cohort (8 patients) was completed on April 2nd, 2010. This cohort intended to demonstrate safety and tolerability of the applied dose in patients suffering from traumatic brain injury. The design of the following cohort will now be placebo-controlled, randomized and double blind.
About the NOSTRA trial:
The NOSTRA trial is an explorative European multicentre placebo-controlled, randomized, double blind study examining safety and tolerability as well as pharmacodynamic effects and pharmacokinetics of the compound VAS203. VAS203 is novel type of NO-synthase inhibitors competing with its co-factor tetrahydrobiopterin.
In total, 32 patients will be enrolled in three cohorts in five study centres. All study centres are routinely using the microdialysis technique which shall be instrumental to measure the NO- and energy metabolism as well as the presence of the compound in the brain tissue. The study is expected to run until the first quarter of 2011.
vasopharm is focused on the development of therapeutics which permits modulating the bioavailability of biological NO, by addressing the entire NO/cGMP signal cascade and its functional counterpart NOX. vasopharm’s drug candidate VAS203 represents a completely new class of NOS modulators targeting cerebral vessels and cerebral tissue, thus preventing life threatening rises in intracranial pressure.back