Recruitment complete for Ph IIa trial of KeyNeurotek's brain injury drug

Germany's KeyNeurotek Pharmaceuticals AG says that patient recruitment for its traumatic brain injury study KN38-7271-001 has been completed on schedule. The European Phase IIa trial is assessing the safety and tolerability of the firm's lead candidate, KN38-7271, in traumatic brain injury patients.

In addition, the company is hoping for therapeutic efficacy signals. In the double-blind, placebo-controlled study, KN38-7271 was administered at two different dose levels. Since November 2006, 97 patients with severe traumatic brain injury have been recruited in three European countries, including Germany. Results of the study are expected in the summer of 2009.

Drug candidate KN38-7271 is characterized by a very innovative, dual mode of action. As a so-called cannabinoid receptor agonist, it activates CB1- and CB2-receptors on nerve and immune cells. It thereby enhances natural protection mechanisms and at the same time prevents critical inflammatory responses.