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GB Sciences Pursues FDA-Registered, First-in-Human Trial of Cannabis-based Therapy for Parkinson's Disease
GB Sciences Pursues FDA-Registered, First-in-Human Trial of Cannabis-based Therapy for Parkinson's Disease.
About this update from Gb Sciences, Inc.
[{"type":"text","content":"\n\n\n\nGB Sciences Pursues FDA-Registered, First-in-Human Trial of Cannabis-based Therapy for Parkinson's Disease\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nGB Sciences Pursues FDA-Registered, First-in-Human Trial of Cannabis-based Therapy for Parkinson's Disease\nCanada NewsWire\nLAS VEGAS, April 10, 2018\n\n\n\nLAS VEGAS, April 10, 2018 /CNW/ -- GB Sciences, Inc. (OTCQB: GBLX) is planning to file an Exploratory IND and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data on its proprietary cannabis-based therapies for the treatment of early to moderate Parkinson's disease (\"PD\").  The GB Sciences' Exploratory IND program is designed to allow the company to make informed, data-driven choices in selecting and prioritizing the development of multiple, related drug compositions and formulations. An Exploratory IND requires less pre-clinical data and offers a more flexible way to get essential information about potential drug development candidates than a more conventional early phase development program. Performing an FDA-Registered clinical trial, instead of a Nevada-based pilot trial as reported earlier, also translates to quicker entry into international markets with harmonized regulatory standards. \n\n\n \n \n\n \nAs previously reported, GB Sciences has pending US and International patent applications covering multiple, related PD-formulas based on complex mixtures of minor cannabinoids and terpenes from cannabis chemovars. In pre-clinical studies, these complex cannabis-based formulas both increased dopamine production and demonstrated potential neuroprotective properties. The disease processes targeted by GB Sciences' therapeutic mixtures are central to the progression of PD, as well as other related neurological conditions. \n\n\"The Exploratory IND/Phase 0 program allows companies to establish a clinical trial protocol to distinguish between multiple formulations based on various measures, including pharmacological and pharmacodynamic measures that may be predictive of efficacy, as well as measures that will help us assess the ...