As 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.
“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 mechanism of action of our drug candidates,” explains Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences. “GB Sciences believes that its regulatory strategy can deliver enough data to allow us to select one or more optimal candidates for development,