A drug called Cethrin shows promise in treating people with spinal cord injury (SCI), according to a study by American and Canadian researchers.
Cethrin inhibits Rho, a signaling master switch that, when activated, triggers cell death and increases damage after SCI. Tests in animals with SCI have found that Cethrin inhibits cell death and promotes neural regeneration.
This one-year study looked at the use of Cethrin (a recombinant protein) formulated with a fibrin sealant in 37 patients who had just suffered an SCI that left them with no sensory or motor function below the area of the injury.
All the patients had an “A” grade injury as ranked by the American Spinal Injury Association (ASIA). Grades of injury go from A through E. An “A” is the most serious while “E” is normal.
After the patients had surgical decompression/reconstruction, the researchers started treatment with Cethrin, an average of 53 hours after the injury occurred. The patients received increasing doses of the drug (0.3, 1.0, 3.0 and 6 milligrams) administered extradurally to the injured spinal cord. The patients were assessed at various points over a year.
The study found that at six weeks, 30.6 percent of the patients improved by one or ASIA grades of injury. At six months, 28 percent of patients improved by one or more ASIA grades. Five patients improved to “C” and two improved to “D.” One patient died from acute respiratory distress syndrome.
The study, which was funded by BioAxone Therapeutique of Montreal and Boston Life Sciences Inc., was presented Monday at the annual meeting of the American Association of Neurological Surgeons, in Washington, D.C. The findings from this Phase I/II study warrant moving on to a prospective randomized trial of Cethrin, the researchers said.