FHI Clinical to Write Clinical Trial Protocol for Development of Gb Sciences' COVID-19-Related, Anti-Inflammatory Therapies

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Plant-inspired biopharmaceutical company signs leading contract research organization to help with a go-to-market strategy for its cannabinoid-containing therapy for COVID-related cytokine release syndrome.

LAS VEGAS, May 02, 2022 (GLOBE NEWSWIRE) -- Gb Sciences, Inc. (OTCQB:GBLX), a leading plant-inspired, biopharmaceutical research and drug development company, announces that FHI Clinical Inc. will consult on Gb Sciences' go-to-market strategy for its COVID-19-related, anti-inflammatory therapeutics and, ultimately, write Gb Sciences' draft clinical trial protocol for a first-in-human trial of these proprietary cannabinoid-containing formulations. 

FHI Clinical has supported 23 COVID trials, with 19 currently in progress, and has agreed to consider the clinical trial phase for the company when its novel plant-inspired therapy is ready for first-in-human testing. 

"FHI Clinical is a leader in conducting human trials of COVID-19 drug therapies and is the best partner to assist us in positioning our drug candidates within this growing market sector," said Dr. Andrea Small-Howard, President and Chief Science Officer of Gb Sciences.

While many other COVID-19 drugs are for use late in the disease process when patients are seriously ill, Gb Sciences' anti-inflammatory therapy is being developed as a preventative drug that patients would take when they first learn that they have been exposed to an infected patient or start feeling sick. Because Gb Sciences' therapeutics target the human immune response to viruses, they could potentially be used for protection against the adverse effects of any viral infection that triggers hyperinflammation. 

"We're very excited to be assisting Gb Sciences in the development of potential COVID-19 treatments utilizing this promising class of molecules," said Jon "Ben" Woods, M.D., Senior Medical Advisor, FHI Clinical.

Gb Sciences has received positive proof-of-concept data from a human immune cell model supporting its proprietary cannabinoid-containing mixtures designed for the suppression of COVID 19-related cytokine release syndromes, while preserving key antiviral immune responses. FHI Clinical will assist Gb Sciences in the verification of this proof-of-concept data by writing the protocol for their first-in-human clinical 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 cannabinoid-containing 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 FHI Clinical

FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research around the world. Benefitting from our 50+ year history of clinical research, our global team has worked on studies in more than 70 countries. As problem solvers, forward thinkers and on-the-ground members of those communities, we are dedicated to helping you find solutions to the research challenges that have kept life-saving therapies from at-risk populations. Visit fhiclinical.com or contact us at info@fhiclinical.com or 919.321.3321 to learn how we can put our diverse clinical and operational expertise to work for you.

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.

Media Contact

Mike Albanese
mike.albanese@newswire.com

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