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In search of further data
LAS VEGAS—GBS Global Biopharma Inc., the Canadian entity of GB Sciences Inc., signed an amendment to an existing agreement with the National Research Council of Canada (NRC) that will extend their efforts in the neurological arena. In animal models, the NRC was able to show that GB Sciences' Parkinson's disease (PD) formulations were capable of inducing statistically significant reductions in behavioral changes associated with dopaminergic neuron loss in the brain.
As a result, the organizations have signed an amendment that covers a final phase of testing to evaluate the mechanism of action for GB Sciences' cannabinoid formulations. The company intends to include the preclinical results in its Investigational New Drug application, and hopes to begin human clinical trials 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,” Dr. Andrea Small-Howard, chief science officer and director of both GB Sciences and GBS Global Biopharma, said in a press release. “The NRC lab in Halifax has improved upon a zebrafish model of Parkinson’s disease that allows us to rapidly validate our PD formulas and efficiently optimize them. Unlike rodent models of PD 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. Each experiment takes about a week to complete and each treatment group has a minimum of 25 individuals, which makes statistical significance easier to reach quickly.
“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. At the NRC, they can directly measure the loss or protection of the dopamine-producing neurons in response to our PD formulas. They will also be measuring conserved neuroinflammatory biomarkers in the zebrafish, which may underlie the disease-causing processes in humans.”
The zebrafish model addresses the underlying pathology of Parkinson's disease, making use of a neurotoxin to recreate PD-like symptoms that mimic those caused by the loss of dopaminergic neurons. Zebrafish are a popular choice for preclinical animal models because despite physiological differences, they share many genetic similarities with humans. In addition, their lifecycle is very short and they reproduce rapidly, making it easy to conduct experiments with multiple generations.
“Although there is no single animal model for PD that is entirely predictive of the human disease, we believe this zebrafish model may be superior to the rodent models due, in part, to its high-throughput, low-cost nature,” commented Dr. Lee Ellis, team lead for zebrafish toxicology, genomics and neurobiology at NRC. “We look forward to extending our studies of GBS’ PD formulas. These positive preclinical results suggest that the zebrafish model for Parkinson’s disease is valuable for demonstrating that cannabinoid-containing complex mixtures may be useful for the treatment of Parkinson’s disease symptomology.”
Parkinson's disease is characterized by the loss of dopamine-producing neurons in the brain. As these neurons are lost, electrical impulses to the body's muscles are interrupted, which results in tremor, stiffness and other motor control issues. While there are some anecdotal and clinical reports to support the use of cannabinoid products in managing Parkinson's disease, clinical trials have either been small or had varied methods of administration, making it difficult to come to any solid conclusions. The endocannabinoid system in the brain consists of cannabinoid receptors that trigger a response to cannabis and its byproducts, and those receptors are “linked to neurons that regulate thinking and some body functions,” per the Parkinson’s Foundation.
“Marijuana contains more than 100 neuroactive chemicals that work with two types of cannabinoid receptors, type 1 (CB1) located in the brain and type 2 (CB2) located in the brain and peripheral immune system. Cannabinoids have powerful, indirect effects on these receptors, but researchers are unsure how,” the Parkinson's Foundation reports. “People with PD have less CB1 receptors than people who do not have PD. A boost to the CB1 receptor through an agonist, like marijuana, can improve tremors and may alleviate dyskinesia. Similarly, the other receptor, CB2, is also being studied to determine if it can modify the disease or provide neuroprotective benefits. However, a unified hypothesis does not currently exist for either receptor because there is too much conflicting data on the effectiveness of cannabinoids and these receptors.”
According to the Parkinson's Foundation, approximately one million individuals in the United States have Parkinson's disease, and more than 10 million are living with this neurodegenerative disease worldwide. The Foundation notes that “The combined direct and indirect cost of Parkinson’s—including treatment, social security payments and lost income—is estimated to be nearly $52 billion per year in the United States alone.”