Exploratory IND Is Planned Using GB Sciences’ Proprietary Mixtures of Botanical Compounds to Provide the Highest Efficacy for Patients
GB Sciences Is Seeking Partners to Supply Minor Cannabinoids for Parkinson’s Disease Clinical Trial
LAS VEGAS, April 17, 2018 /PRNewswire/ — GB Sciences, Inc. (OTCQB: GBLX), as previously reported, plans to file an Exploratory IND and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data, to support clinical development decisions on prioritizing among multiple, related Parkinson’s Disease (“PD”) formulations. GB Sciences has a patent application covering multiple, related PD-formulas that are based on complex mixtures of minor cannabinoids and terpenes from cannabis chemovars. In preclinical studies, GB Sciences has demonstrated that complex mixtures of cannabis-based compounds may provide greater clinical benefits than single compound treatments due to molecular synergies for the treatment of Parkinson’s.
Sourcing sufficient quantities of these minor cannabinoids and terpenes is essential for providing the highest possible efficacy in GB Sciences’ PD formulations, but they are more difficult to procure in botanical form because they are in lower abundance in the cannabis plants. GB Sciences has been addressing these supply issues at its cultivation and extraction facility in Las Vegas, Nevada; however, currently there is only a sole source for domestic cannabis used in FDA research.
“The challenge we have encountered in approaching the US FDA is that we may not be able to use cannabis-based materials that GB Sciences has developed in the US for our clinical trials,” explains Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences. “We are committed to complying with all federal requirements, even though we believe we can implement a system for growing and extracting here that exceeds the quality and consistency of the materials that we could obtain from the only federally-approved cannabis source for research in the US.”
As a result, the company is now seeking additional international suppliers in harmonized countries that produce minor cannabinoids and terpenes to ensure that it can expand testing beyond the initial Phase 0 Trial. Interested parties should contact GB Sciences and Dr. Small-Howard at firstname.lastname@example.org.
About GB Sciences, Inc.
GB Sciences, Inc. (OTCQB: GBLX) is a diverse cannabis company, focused on standardized cultivation and production methods; as well as biopharmaceutical research and development. The Company’s goal is creating safe, standardized, pharmaceutical-grade, cannabinoid therapies that target a variety of medical conditions. To learn more about GB Sciences, Inc., go to: http://gbsciences.com.
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.
Note: Although the Company’s research and development activities are not illegal, the production and sale of cannabis products violate federal laws as they presently exist.
GB Sciences, Inc., 3550 West Teco Ave., Las Vegas, NV 89118
Tom Arcuragi, EVP, email@example.com
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SOURCE GB Sciences, Inc.