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.”