UNews - Andrea Small-Howard

��Ѹ��Դ��߿�Ƭ of Lethbridge completes dose response study for Gb Sciences’ new Parkinson’s Disease Therapy

caroline.zentner — Tue, 11 Jul 2023 15:43:15 +0000

LAS VEGAS, July 11, 2023 (Newswire.com) - Gb Sciences, Inc., a leading cannabis- and plant-inspired biopharmaceutical research and development company, has successfully completed a dose response study in rodents at the ��Ѹ��Դ��߿�Ƭ of Lethbridge that supports Gb Sciences’ cannabinoid-based therapy for Parkinson’s disease. The study has established dose ranges and the corresponding times to onset and duration of action in a rodent model. In addition to the dosage range findings, this study demonstrated that Gb Sciences’ Parkinson’s disease formulations were well tolerated, and there were no adverse effects. As early as next year, Gb Sciences plans on filing an Investigational New Drug Application to begin first-in-human clinical trials. As the second most common neurodegenerative disease, the market for Parkinson’s disease (PD) treatments is expected to grow to $12.8 billion by 2028.

“Gb Sciences is developing a first-in-class, cannabinoid-based treatment for the motor symptoms of Parkinson’s disease,” says Dr. Andrea Small-Howard, President, Chief Science Officer and board member of Gb Sciences, Inc. “From this critical study, we have established ranges for the dosage and duration of action in a rodent model that helps us to predict the corresponding and appropriate dose range and duration of action of Gb Sciences’ Parkinson’s disease therapies for our first-in-human trial. Additionally, this study augments our safety data and suggests that our novel therapeutic may also help alleviate the significant non-motor symptoms of the disease such as problems with sleeping and appetite.”

The dose response study in rodents performed at ULethbridge helps to establish the correct dosing of Gb Sciences’ cannabinoid-containing Parkinson’s formulations for a first-in-human trial. Dr. Robert Sutherland, Ph.D., FRSC, Professor and Chair of the Department of Neuroscience at the ��Ѹ��Դ��߿�Ƭ, Board of Governors Research Chair in Neuroscience and Director of the Canadian Centre for Behavioral Neuroscience, used deep learning models to analyze the rich data sets from their “Home Cage Small World” behavioural assessments of rodents with video cameras and Artificial Intelligence, using a system developed by Neurocage Systems Ltd. Future studies confirming the mechanism of action of these cannabinoid-based Parkinson’s formulations are planned with Dr. Sutherland’s research group at ULethbridge using their state-of-the-art behavioural measurement methods for rodents.

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 U.S. and five foreign patents issued, one US and three foreign patents allowed; as well as 18 U.S. and 55 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 of Canada (NRC). The company received positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State ��Ѹ��Դ��߿�Ƭ. The Company has also received positive preclinical proof-of-concept data supporting its phytochemical mixtures for the treatment of anxiety. Gb Sciences' productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. To learn more, visit www.gbsciences.com.

Forward-Looking Statements

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��Ѹ��Դ��߿�Ƭ of Lethbridge chosen to conduct dosage study for novel Parkinson’s disease formulations

trevor.kenney — Tue, 12 Apr 2022 17:00:07 +0000

Biopharmaceutical research company GB Sciences’ plant-inspired formulations entering the final stages before first-in-human clinical trials

Gb Sciences , Inc. (OTCQB:GBLX), a leading plant-inspired biopharmaceutical research and development company, has selected the ��Ѹ��Դ��߿�Ƭ of Lethbridge to complete a dose range study of Gb Sciences’ patent-protected formulations in a rodent model of Parkinson’s disease (PD).

Dr. Robert Sutherland, shown here on the left, and his lab will determine the dose range of active ingredients that will be used in human trials and will identify potential side effects.

“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 ��Ѹ��Դ��߿�Ƭ of Lethbridge and the exceptional innovative programs, this promises to be an outstanding, productive partnership,” says Dr. Robert Sutherland, professor and Chair of the Department of Neuroscience at ULethbridge; Board of Governors Research Chair in Neuroscience; and director of the Canadian Centre for Behavioural Neuroscience.

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 ULethbridge 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 response studies are scheduled to begin next month.

“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,” says Sutherland.

“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,” says Dr. Andrea Small-Howard, president and chief science officer of Gb Sciences. “Now, working with the ��Ѹ��Դ��߿�Ƭ 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.

To learn more about Gb Sciences, visit www.gbsciences.com.

About Gb Sciences and GbS Global Biopharma

UNews - Andrea Small-Howard

��Ѹ�����Դ���߿�Ƭ of Lethbridge completes dose response study for Gb Sciences’ new Parkinson’s Disease Therapy

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��Ѹ�����Դ���߿�Ƭ of Lethbridge chosen to conduct dosage study for novel Parkinson’s disease formulations

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��Ѹ��Դ��߿�Ƭ of Lethbridge completes dose response study for Gb Sciences’ new Parkinson’s Disease Therapy

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