BioAxone Therapeutic has announced that it has completed its targeted patient enrollment of the Phase I/IIa North American clinical trial of Cethrin for the treatment of acute spinal cord injury. 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. Results of the trial are expected in the fall of 2006.
The trial is an open-label safety and pharmacokinetic study in which the drug is administered to patients with acute thoracic or cervical spinal cord injuries. The study, conducted in 37 patients in nine centers in the U.S. and Canada, is designed to evaluate the safety and tolerability of Cethrin. The protocol entails four escalating doses and includes patients with complete thoracic or cervical injury. Although the trial is not placebo-controlled, it has an exploratory efficacy component based on the American Spinal Injury Association's classification scale, designed to detect improvements in sensory and motor function of patients.