Minocyline shows promise for limiting the severity of spinal cord injuries at a fraction of time and cost of other new drug treatments, says Rick Hansen Institute
August 14, 2014 VANCOUVER - The Rick Hansen Institute (RHI) is pleased to announce an international clinical trial to test promising research that suggests minocycline may decrease the severity of acute spinal cord injury (SCI).
RHI has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) to conduct the minocycline phase III clinical trial in Australia on individuals with acute SCI. The TGA is Australia's regulatory authority for therapeutic goods and receiving approval was a key milestone in commencing the Minocycline clinical trial in Australia.
This marks the study’s first site outside of Canada and RHI will be working with Brisbane’s Queensland University of Technology and Princess Alexandra Hospital to initiate the study and begin recruiting participants. RHI currently sponsors this trial at the University of Calgary/Foothills Medical Centre in Alberta and Victoria Hospital, London Health Sciences Centre in Ontario with several more Canadian sites currently in development. The study’s Principal Investigator is Dr. Steve Casha from the University of Calgary.
"International collaboration is vital to identify and validate the most promising discoveries and accelerate the translation of those discoveries into clinical practice." said RHI's CEO, Bill Barrable.
Minocycline, a common antibiotic used to treat acne and other bacterial infections for over 30 years, has also demonstrated neuroprotective properties by minimizing inflammation and secondary damage to the spinal cord immediately after injury. Whereas new drug development typically requires up to 20 years and investments in the hundreds of millions of dollars, minocycline has the potential to be translated into clinical practice in a fraction of the time and cost of new drug development because its safety is well established and generic versions of the drug are readily available.
A previous 52-patient phase II study at the University of Calgary/Foothills Medical Centre was completed under the direction of Dr. Casha to evaluate the effectiveness of intravenous minocycline, administered less than 12 hours after injury. Results suggested a tendency towards improvement in both long-term physical motor recovery and functional outcomes in patients with cervical injury, as early as three months post-injury.
Learn more about the results from the phase II study in this article published in Brain.
“We are thrilled to receive approval from the Australian TGA to begin the minocycline study – a major milestone in the development of this study with the Rick Hansen Institute. The pilot study in Canada showed very promising results and we hope that this current trial will show the efficacy of Minocycline in improving functional outcome after acute non-penetrating spinal cord injury,” said Professor Michael Schuetz who is leading the minocycline trial at the Princess Alexandra Hospital.
“RHI is pleased to be able to work with colleagues at Princess Alexandra Hospital on the minocycline clinical trial. International collaboration is vital to identify and validate the most promising discoveries and accelerate the translation of those discoveries into clinical practice. Our partnership with Princess Alexandra Hospital will help identify the potential of minocycline to be used as a neuroprotective therapeutic treatment for individuals with traumatic spinal cord injury and therefore reduce the severity of the injury and long term costs to the health care systems here and abroad,” added RHI’s CEO, Bill Barrable.
THE REALITY OF SPINAL CORD INJURY
SCI is one of the greatest survivable catastrophes experienced by a human being. Regardless of cause or age at injury, SCI has a devastating impact on an injured person’s health and well-being, and far-reaching consequences for individuals, their families and the health care system.
Required care is highly specialized and complex – including costs for acute, rehabilitative, emergency, primary, mental health, home and long term care and adaptive equipment – resulting in substantial financial costs for governments. In Canada, the cost of care for people with traumatic SCI is now estimated at approximately $2.7 billion a year.
ABOUT THE RICK HANSEN INSTITUTE
The Rick Hansen Institute is a Canadian-based not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries. It does this by leading the collaboration of researchers, health care professionals and service providers across Canada and internationally. Established in 2007 by the Rick Hansen Foundation, RHI has matched leadership and research collaboration with government funding to facilitate one of the largest interdisciplinary spinal cord injury research programs in the world. For more information, please visit: www.rickhanseninstitute.org.
Funding for the Minocycline study is provided by Western Economic Diversification Canada, Health Canada, Government of Alberta and the Queensland Government.