Canadian drugmaker BioAxone Therapeutic has completed the targeted patient enrollment of a Phase I/IIa clinical trial of Cethrin (recombinant protein-based inhibitor of Rho signaling), its candidate treatment for acute spinal cord injury. Results of the evaluation are expected in the fall.
The agent will be co-delivered with a fibrin sealant and administered once directly onto the surface of the spinal cord during spinal decompression surgery. The open-label pharmacokinetic trial, to be conducted in 37 patients with acute thoracic or cervical spinal cord injuries across nine centers in the USA and Canada, is also designed to evaluate safety and tolerability.
Montreal-based BioAxone noted that, 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.
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