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Gb Sciences Achieves Positive Proof-of-Concept Results for Their Cytokine Release Syndrome Therapies Designed to Suppress COVID-Related Hyperinflammation

14 September 2021

Gb Sciences, Inc. (OTCQB: GBLX) received positive proof-of-concept data from a human immune cell model supporting their proprietary cannabinoid-containing complex mixtures (CCCM) designed for the suppression of COVID-related cytokine release syndromes (CRS) while preserving key anti-viral immune responses. Based on this new positive proof-of-concept data, Gb Sciences converted their provisional patent application entitled, "CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF CYTOKINE RELEASE SYNDROME WHILE PRESERVING KEY ANTI-VIRAL IMMUNE REACTIONS" to a nonprovisional patent application on August 18, 2021. The best-performing cannabinoid-containing complex mixtures will be further developed in preparation for clinical studies to evaluate their anti-inflammatory potential in the treatment of severely ill COVID-19 patients contending with Cytokine Release Syndrome (CRS) and associated hyperinflammatory conditions, such as macrophage activation syndrome (MAS) and acute respiratory distress syndrome (ARDS). CRS, MAS, and ARDS are the leading causes of death in COVID-19 patients. 

Gb Sciences' proof-of-concept study was performed at Michigan State University using a state-of-the-science human immune model. In Gb Sciences' proof-of-concept study, immune cells from human donors were co-cultured together in one of four treatment groups: untreated (no inflammatory stimulus), inflammatory stimulus, control (inflammatory stimulus + vehicle from cannabinoid mixtures), or pre-treatment with the cannabinoid mixture + inflammatory stimulus. Then a panel of cytokines and inflammatory markers was measured from each of these treatment groups from different immune cell types within the co-cultured cells at four time points to determine whether Gb Sciences' cannabinoid mixtures were able to alter the levels of pro-inflammatory cytokines or other inflammatory agents.

The study was led by Dr. Norbert Kaminski, Professor of Pharmacology and Toxicology, Director of the Institute for Integrative Toxicology and director of the Center for Research on Ingredient Safety at MSU. "Gb Sciences' novel cannabinoid-containing mixtures showed potential for immunomodulation of pro-inflammatory processes in our human immune cell model," said Dr. Kaminski. "Further research will help us better understand how the active ingredients work together in this system."

Gb Sciences' cannabinoid-containing complex mixtures are designed to reduce the life-threatening levels of specific cytokines and pro-inflammatory processes triggered by SARS-CoV-2, while preserving the immune functions and cytokines necessary for fighting the virus. These proof-of-concept results supported the potential for some of these mixtures to accomplish this goal, but, ultimately, clinical trial results will determine whether they can fully accomplish our therapeutic goals.

"By creating and funding an innovative cannabinoid-based research program, Gb Sciences has demonstrated that we can profoundly change the way that cannabinoids are used within optimized therapeutic mixtures designed for the management of inflammation, pain, and other unmet medical needs," said company President and Chief Science Officer, Dr. Andrea Small-Howard. "Our plant-based drug discovery platform is advancing biopharmaceutical research at a time when thousands are dying from COVID-19. The next step is to further develop our plant-inspired drugs and eventually bring them to human trials so that the use of well-defined cannabinoid mixtures in clinical practice can become a reality."

For additional information on how Gb Sciences' optimized therapeutic mixtures are poised to revitalize treatments for Parkinson's disease, pain, and inflammation, please visit: gbsciences.com.

About Gb Sciences, Inc.

Gb Sciences, Inc. (OTCQB: GBLX) is a plant-based research and biopharmaceutical drug development company whose goal is to create patented formulations of plant-inspired, optimized therapeutic mixtures (OTM) that target a variety of medical conditions through their Canadian entity, GbS Global Biopharma, Inc. The 'plant-inspired' active ingredients in our OTM are synthetic homologues identical to the original plant compounds but produced under current Good Manufacturing Practices. Gb Sciences' novel drug discovery platform has yielded 5 issued US and 3 issued international patents, as well as 19 US and 40 international patent-pending applications. In our drug development pipeline, we have four preclinical stage programs, and our lead Parkinson's disease therapeutic program is being prepared for a First-in-Man clinical trial. In addition to Parkinson's disease, Gb Sciences is developing therapeutics for COVID-related cytokine release syndrome (CRS), chronic pain, Mast Cell Activation Syndrome (MCAS), and heart failure. Gb Sciences' productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. https://gbsciences.com

About Michigan State University

Michigan State University is the nation's pioneer land-grant university and one of the top research universities in the world. Every day, Spartans work to solve the most pressing global challenges while providing life-changing opportunities to a diverse and inclusive academic community. Located in East Lansing, three miles east of Michigan's capitol in Lansing, MSU's campus is one of the biggest and greenest in the nation. Top-ranked programs, high-caliber opportunities and an inclusive, collaborative community enable Spartan students to create powerful, personalized paths and to compete with the best in the world. https://msu.edu

Forward-Looking Statements

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.

Contact Information

GB Sciences, Inc.
3550 West Teco Avenue,
Las Vegas, NV 89118
1-866-721-0297
This email address is being protected from spambots. You need JavaScript enabled to view it.   

Media Contact

Savannah Muir 
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Image 1: Gb Sciences, Inc.

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