The National Research Council (NRC) of Canada will conduct a final phase of preclinical testing of GB Sciences‘ cannabinoid-based formulations for Parkinson’s disease to determine their mechanisms of action.
This final step in testing follows promising results in a fish model of the disease, in which these cannabinoid-based mixtures significantly eased behavioral symptoms linked to the loss of dopamine producing-nerve cells — a hallmark of Parkinson’s.
The findings led GBS Global Biopharma, the Canadian arm of the company, to amend the original agreement with the NRC and include these additional tests.
Results will support the filing of an investigational new drug application with the U.S. Food and Drug Administration, in hopes that a clinical trial for the formulations can start later this year.
“We have expanded the scope of testing with the NRC for our Parkinson’s formulations based on achieving the statistically significant reduction in Parkinson’s disease symptomology faster than expected,” Andrea Small-Howard, PhD, chief science officer and director of both GB Sciences and GBS Global Biopharma, said in a press release.
Several studies examining cannabinoids — the active chemicals that give the cannabis plant its medical and recreational properties — have suggested an ability to ease the motor symptoms of Parkinson’s disease.
GB Sciences is creating a pipeline of new medicines based on its patent-pending formulations of chemicals extracted from the cannabis plant. Some of these formulations significantly eased motor symptoms of Parkinson’s in animal models of the condition, according to research done at the NRC.
Led by Lee Ellis, PhD, of the NRC, the team improved an already existing zebrafish model of Parkinson’s that mimics the symptoms of the disease. This model helped researchers validate the company’s formulations and optimize them to provide extended benefits.
“Unlike rodent models of [Parkinson’s disease] that take months to run with just a few animals in each treatment group, the zebrafish model of Parkinson’s disease is a high throughput system,” Small-Howard said. “Each experiment takes about a week to complete and each treatment group has a minimum of twenty-five individuals, which makes statistical significance easier to reach quickly.”
In this fish model, disease-like symptoms are induced by giving the animals a neurotoxin. This allows researchers to study the role of the cannabinoid-based formulations in the underlying symptoms of Parkinson’s rather than the genetic markers associated with the condition.
Also, because zebrafish have a nervous system and a primitive immune system, researchers will be able to assess if the cannabinoid-based formulations are easing symptoms by protecting the animals’ dopamine-producing neurons.
The formulations’ mechanism of action will also be examined by measuring biomarkers of neuroinflammation.
“Not only does the zebrafish model provide symptomatic data, we can also use this model to address the mechanism for how our formulas might be able to provide relief to Parkinson’s patients,” Small-Howard said.
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