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KeyNeurotek Pharmaceuticals AG Reports Positive Phase I Data of Its Cannabinoid Receptor-Agonist
The placebo-controlled, double blind, dose escalating study was performed in 18 healthy individuals. Primary objective of this Phase I study was to investigate the safety and tolerability of the drug given as a single intravenous infusion over 24 hours, whereas pharmacokinetic and pharmacodynamic effects of KN38-7271 were defined as secondary endpoints.
KN38-7271 was found to be safe and well tolerated at both doses tested, i.e. 1.5 and 3.0 µg/24 h. The pharmacokinetic analysis revealed a doubling of the KN38-7271 concentration in the blood serum with doubling of the drug dose. Dose-normalised parameters as Cmax and AUC were comparable for both dose levels used. The apparent terminal half-life (9-15 h for the low dose and 14-22 h for the high dose) and also the related apparent volume of distribution during terminal phase increased with the higher dose. The pharmacodynamic effects of KN38-7271 were generally inconspicuous.
KN38-7271 is already being tested by KeyNeurotek Pharmaceuticals in an international Phase II study in patients with traumatic brain injury (TBI) since the end of 2006. The cannabinoid receptor agonist activates both CB1 and CB2 receptors in the brain, strengthening important natural protection mechanisms and preventing overacting inflammatory reactions. Dr Frank Striggow, CEO of KeyNeurotek Pharmaceuticals AG, said: We are very pleased about the positive results of this dose-escalating Phase I trial. These data provide a maximum of flexibility to perform further dose-finding Phase II trials in patients suffering from stroke and/or TBI."
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