Biopharmaceutical research company's plant-inspired formulations entering final stages before first-in-human clinical trials
LAS VEGAS, April 12, 2022 (Newswire.com) - Gb Sciences, Inc. (OTCQB:GBLX), a leading plant-inspired biopharmaceutical research and development company, has selected the University of Lethbridge in Canada to complete a dose range study of Gb Sciences' patent-protected formulations in a rodent model of Parkinson's disease (PD). Gb Sciences plans on filing an Investigational New Drug Application to begin first-in-human clinical trials as early as next year. As the second-most common neurodegenerative disease, the market for Parkinson's disease treatments is expected to grow to $8.8 billion by 2026.
Gb Sciences received U.S. Patent No. 10,653,640 in May 2020 for its proprietary cannabinoid-containing therapeutic mixtures for the treatment of PD. Animal studies conducted by the National Research Council of Canada found that Gb Sciences' PD formulations achieved statistically significant reductions in the PD-like motor symptoms associated with the loss of dopamine-producing neurons. Initial toxicity studies for these original PD formulas came back with no significant evidence of adverse effects.
Through GbS Global Biopharma, its wholly owned Canadian subsidiary, Gb Sciences has signed a contract with the University of Lethbridge, located in Alberta, Canada, to complete required rodent dose response studies. These important studies will determine the dose range of active ingredients that will be used in human trials and will identify potential side effects. These dose range studies are scheduled to begin next month.
"Our drug discovery process has identified ratio-specific mixtures of cannabinoids that achieved the statistically significant reduction of Parkinsonian movement symptoms in an animal model; thus establishing our proof-of-concept for this therapeutic program," said Dr. Andrea Small-Howard, President and Chief Science Officer of Gb Sciences. "Now, working with the University of Lethbridge, we are taking a major step forward by testing these cannabinoid ratio-specific formulations to establish the dose range for our first-in-human clinical trial."
To create Gb Sciences' novel therapies, the company's goal is to identify 'minimum essential mixtures' that retain the efficacy of whole plant extracts, but with the manufacturing and quality control advantages of single ingredient pharmaceutical products. Gb Sciences uses its novel PhAROS™ (Phytomedical Analytics for Research Optimization at Scale) drug discovery engine's predictive capabilities, combined with rigorous high throughput screening of potential combinations of these plant-derived compounds in established cellular models of disease to determine which minimum essential mixtures from these plant-based materials may be therapeutically beneficial. These minimum essential mixtures are then validated and refined in animal models, in preparation for the first-in-human trial.
"Gb Sciences is an innovator in drug discovery and development, and they have promising drug candidates for the treatment of Parkinsonian movement disorders. With the state-of-the-art behavioral measurement methods at the University of Lethbridge and the exceptional innovative programs, this promises to be an outstanding, productive partnership," said Dr. Robert Sutherland, Ph.D., FRSC, Professor and Chair of the Department of Neuroscience at the University of Lethbridge, Board of Governors Research Chair in Neuroscience, and Director of the Canadian Centre for Behavioral Neuroscience. "Using rodent models of PD-motor symptoms, we should be able to predict the appropriate dose range and duration of action of Gb Sciences' PD therapies for its first-in-human trial."
To learn more about Gb Sciences, visit www.gbsciences.com.
About Gb Sciences and GbS Global Biopharma
Gb Sciences, Inc. is a plant-inspired, biopharmaceutical research and development company creating patented, disease-targeted formulations of cannabis- and other plant-inspired therapeutic mixtures for the prescription drug market through its Canadian subsidiary, GbS Global Biopharma, Inc. The 'plant-inspired' active ingredients in its therapeutic mixtures are synthetic homologues identical to the original plant compounds but produced under current Good Manufacturing Practices. Gb Sciences' intellectual property portfolio contains six issued U.S. and three issued foreign patents, as well as 18 U.S. and 49 foreign patent-pending applications. In its drug development pipeline, Gb Sciences has five preclinical phase product development programs. Gb Sciences' lead program for Parkinson's disease is being prepared for a first-in-human clinical trial. Gb Sciences' formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council Canada. The company also recently received positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome related to COVID-19, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Gb Sciences' productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. To learn more, visit www.gbsciences.com.
About the University of Lethbridge
Founded in 1967, on traditional Blackfoot land, the University of Lethbridge is home to 8,900 undergraduate and graduate students from around the world. With campuses in Lethbridge and Calgary, we are one of Canada's top-ranked universities and leading research institutions. Our Blackfoot name, gifted to us by Elder Bruce Wolf Child, is Iniskim, meaning Sacred Buffalo Stone. The University of Lethbridge is a board-governed public post-secondary institution operating in Alberta as a comprehensive academic and research university under the authority of the Post-secondary Learning Act.
Located in the heart of traditional Blackfoot Confederacy territory, the University of Lethbridge serves the people of southern Alberta through programs, research and creative activity that contribute to economic and social prosperity locally and globally. Founded on the principles of liberal education, the University of Lethbridge is broad in scope while promoting excellence in undergraduate and graduate education that prepares students to understand and address an increasingly complex and interconnected world. The University fosters a learning community that meets the educational and personal growth needs of its students by offering a learning community emphasizing teaching excellence; exposure to research; information literacy; interaction with professors and instructors; effective academic advising, applied learning opportunities, and career counseling; and a spectrum of cultural, recreational, and extracurricular opportunities. To learn more, visit www.ulethbridge.ca.
This press release may contain statements relating to future results or events, which are forward-looking statements. Words such as "expects", "intends", "plans", "may", "could", "should", "anticipates", "likely", "believes" and words of similar import may identify forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further, information concerning the Company and its business, including factors that potentially could materially affect the Company's business and financial and other results, are contained in the Company's filings with the Securities and Exchange Commission, available at www.sec.gov. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
Source: Gb Sciences