Toronto (March 13, 2015) – Basic Research conducted by Dr. Michael Tymianski over the past 18 years at the Toronto Western Research Institute (TWRI) is now culminating in a nation-wide Phase 3 clinical trial. Dr. Tymianski and his team have been developing a drug, now called NA-1, to be used as an emergency treatment aimed at reducing the damaging effects of stroke.
The story of the development of NA-1 was chronicled in the Globe and Mail in May 2014, and represents a major achievement for research conducted at UHN and specifically at TWRI.
In brief, Dr. Tymianski's team reported in the journal Science (1999) that a protein in brain neurons called PSD95 is important in mediating stroke damage. Three years later, they again reported in Science (2002) the drug NA-1, which blocks PSD95 protein and reduces stroke damage in laboratory animals. Over the ensuing 10 years they developed the drug further, initiated a startup company (NoNO Inc.), and showed that NA-1 reduces stroke damage in patients who undergo strokes in-hospital following endovascular procedures to repair brain aneurysms. Their work was published in prestigious journals including Science Translational Medicine (2012), Nature (2012) and Lancet Neurology (2012).
NA-1 is not a drug designed to break down blood clots in the brain. Rather, it is a neuroprotectant – a drug that enhances the resilience of brain neurons to withstand stroke. Over the past 60 years, more than 1,000 neuroprotectants have been tested in research settings, but none have worked in humans. NA-1 is the first drug in history to show efficacy in reducing stroke damage in patients.
In continuing this multi-year journey to develop a stroke treatment for people, NA-1 will now be tested to determine whether it is effective in improving the outcome of patients who suffer from a stroke in the community.
Paramedics in Toronto, Vancouver, Richmond, B.C. and the Region of Peel in suburban Toronto, will soon administer NA-1 to eligible stroke victims as part of a new 558-patient randomized control trial.
The trial will begin in Toronto on March 16 and then expand to the other cities.
NA-1 has already been shown to reduce damage caused by stroke and to improve brain function for patients undergoing brain surgery.
The study, known as FRONTIER, will compare outcomes when paramedics give either NA-1 or placebo to patients while transporting patients to the closest stroke centre. Once in hospital, patients will receive standard care for strokes.
Canadians who suffer a stroke and receive emergency services support from Peel Regional Paramedic Services, BC Emergency Health Services or Toronto Paramedic Services will be enrolled in the trial, if they meet eligibility criteria.
The Toronto, Vancouver and Region of Peel stroke centres participating in FRONTIER are:
Participant's consent is required before a product is delivered in most clinical trials. However, given the immediate nature of emergency stroke care, the consent process has been deferred to the in-hospital setting once the medical emergency is resolved by Health Canada and the Research Ethics Boards at the centres participating in this trial.
Stroke is the most significant cause of neurological disability and death worldwide. It affects 62,000 Canadians and kills more than 11,000 annually.
The FRONTIER trial is supported by a Multi-Investigator Research Initiative grant from the Brain Canada Foundation and sponsored by NoNO Inc.
For more information, please contact the Rescu at 1-888-707-3015 or www.frontiertrial.ca or https://clinicaltrials.gov/ct2/show/NCT02315443
Previous media stories about the development of NA-1 and the FRONTIER trial can be found at:
