FHI Clinical to write clinical trial protocol for development of Gb Sciences’ COVID-19-related anti-inflammatory therapies

May 2, 2022

FHI Clinical developing go-to-market strategy for cannabinoid-containing therapy for COVID-related cytokine release syndrome

DURHAM, NORTH CAROLINA — FHI Clinical Inc. announces today it will consult on the go-to-market strategy for COVID-19 related anti-inflammatory therapeutics for Gb Sciences, Inc. (OTCQB:GBLX), a leading plant-inspired, biopharmaceutical research and drug development company. FHI Clinical will additionally write the 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 many 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, MD, 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 verification of this proof-of-concept data by writing the protocol for their first-in-human clinical trial.

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 team of approximately 450 global staff 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.

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 gbsciences.com.

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.

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FHI Clinical announces the closing of its acquisition of the clinical trials business of South Africa-based Triclinium Clinical Development (TCD)

February 8, 2022
FHI Clinical Inc. announces today the official closing of its acquisition of the clinical trials business of Triclinium Clinical Development Proprietary Limited (TCD), a full-service, South Africa-based CRO. With the acquisition, FHI Clinical expands its share of the infectious disease (ID) clinical development market and becomes the dominant service provider in sub-Saharan Africa.

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