Cethrin, a recombinant protein-based inhibitor of Rho signaling, is co-delivered with a fibrin sealant and administered once directly onto the surface of the spinal cord during spinal decompression surgery.
The trial is an open-label safety and pharmacokinetic study in which Cethrin was administered to patients with acute thoracic or cervical spinal cord injuries. The study, conducted with 37 patients in nine centers in the US and Canada, is designed to evaluate the safety and tolerability of Cethrin. Results of the trial are expected in the fall of 2006.
In a presentation at the 24th Annual National Neurotrauma Symposium in St Louis, Missouri, the clinical trial’s lead investigator, Dr Michael Fehlings, a professor of neurosurgery at the University of Toronto commented: “Cethrin offers a novel and promising regenerative approach to enhance functional recovery of patients suffering from spinal cord injury. We have seen no adverse events related to the administration of Cethrin at this stage of the study and clinically the results look interesting.”
Cethrin was granted orphan drug status by the FDA in December 2005. Cethrin’s active ingredient, BA-210, is a recombinant protein that acts as a Rho GTPase antagonist to promote neuroprotection and neuroregeneration in the central nervous system.