LAS VEGAS / ACCESSWIRE / April 6, 2020 / GB Sciences, Inc. (GBLX), is pleased to announce that the company's Canadian entity, GBS Global Biopharma, Inc. (GBS), signed an Amendment to their Agreement with the National Research Council of Canada (NRC). The NRC has demonstrated that the company's PD formulations were able to reduce behavioral changes associated with the loss of dopamine-producing neurons, which underlies the pathology of Parkinson's disease in the animal model. Based on achieving the statistically significant reduction in Parkinson's disease symptomology, GBS has signed an amendment to include a final phase of testing, which will study the mechanism of action for these promising formulations. These important preclinical results will be included in GBS' Investigational New Drug (IND) application with US FDA in order to enter human clinical trial as early as this year. New therapies to address Parkinson's disease symptoms are needed to help those afflicted with this debilitating disease. The combined direct and indirect costs associated with Parkinson's disease are estimated at $52 billion in the U.S. alone.
"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," explained Dr. Andrea Small-Howard, Chief Science Officer and Director of both GB Sciences, Inc. and GBS Global Biopharma, Inc. "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 twenty-five 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."
GBS selected this animal model because it addresses the underlying pathology of PD, rather than the genetic markers associated with PD that may be secondary rather than causal. There are two basic types of animal models for Parkinson's disease: 1) those using genetic modifications of the study animals, or 2) those using the application of targeted neurotoxins to induce Parkinson's disease-like symptoms in the study animals. This zebrafish model of PD uses a neurotoxin to induce PD-like symptoms related to the loss of dopamine producing neurons. The loss of dopamine producing neurons is directly related to the major symptoms of PD. In addition, significant neuroinflammatory biomarkers can be measured by the NRC to assess their role in symptomatic relief or disease progression.
"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," said Dr. Lee Ellis, Team Lead-Zebrafish Toxicology, Genomics and Neurobiology at National Research Council Canada. "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."
About GB Sciences, Inc. and GBS Global Biopharma Inc.
GB Sciences, Inc. (GBLX), through their Canadian entity, GBS Global Biopharma, Inc., is a dedicated biopharmaceutical research and cannabinoid-based drug development company whose goal is to create patented formulations for safe, standardized, cannabinoid therapies that target a variety of medical conditions in both the biopharmaceutical and wellness markets.
About the National Research Council of Canada
The National Research Council of Canada (NRC) is Canada's largest federal research and development organization. The NRC partners with Canadian industry to take research impacts from the lab to the marketplace, where people can experience the benefits. This market-driven focus delivers innovation faster, enhances people's lives and addresses some of the world's most pressing problems. We are responsive, creative, and uniquely placed to partner with Canadian industry, to invest in strategic R&D programming that will address critical issues for our future. Each year our scientists, engineers, and business experts work closely with thousands of Canadian firms, helping them bring new technologies to market. We have the people, expertise, services, licensing opportunities, national facilities, and global networks to support Canadian businesses. https://nrc.canada.ca/en/corporate/about-nrc
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