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Translating Promising Therapy into Clinical Practice

Damage to a person’s spinal cord doesn’t stop at the time of injury: the cord can continue to deteriorate for a long time afterwards, for reasons that are still not yet fully understood. This is why research into the cure for spinal cord injuries looks not only at how to repair the initial injury, but also how to prevent this delayed deterioration of the spinal cord after injury has occurred. This second type of research is known as “neuroprotective” research. The work of a team of Alberta researchers into one potential neuroprotective agent, minocycline, has led to an international collaboration to translate this promising therapy to clinical practice.

Previous research has shown minocycline, an antibiotic most commonly used as an acne treatment, to have neuroprotective effects in animals. Because minocycline has been commonly used for over 30 years, research can be undertaken at a fraction of the time and cost it would take for a new drug, which typically requires 17 to 20 years and hundreds of millions of dollars. However, as minocycline is an off-patent drug, pharmaceutical companies have little financial incentive to invest in developing new applications for its use.

If successful, this study holds the potential to yield one of the only neuroprotective drug interventions for acute SCI.

In 2004, Dr. John Hurlbert and Dr. Steven Casha, neurosurgeons at the University of Calgary, led a Phase 2 clinical trial to investigate this drug in humans. A total of 52 patients were recruited for this study from Foothills Medical Centre in Calgary, and followed over three years to demonstrate feasibility and to investigate the changes in humans following administration of minocycline. The results, published in April 2012 in the journal Brain, showed promise for the drug, particularly among certain sub-groups of patients. However, it was recognized that a greater sample size was needed to establish significance.

In recognition of this, the Rick Hansen Institute is sponsoring a Phase 3, multi-centre clinical study, which will involve six sites in five provinces across Canada, with possible additional sites internationally. Expected to be completed in 2018, this study will provide a sample size large enough to establish the effectiveness of minocycline in humans. The study opened for enrollment on 26 June 2013 with the first site initiated at the University of Calgary/Foothills Medical Centre. No study subjects have been enrolled as of 31 July 2013.

If successful, this study will yield one of the only neuroprotective drug interventions for acute SCI, with the potential to improve the lives of people with spinal cord injury by reducing the level of impairment after injury, and reducing costs to the health care system.

Dr. Steve Casha discusses the minocycline study in this short interview.