americanpharmaceuticalreviewDecember 23, 2019
Tag: GB Sciences , Parkinson , PD
GB Sciences announced preclinical results for their Parkinson's disease (PD) formulations from the midterm report for their preclinical study being performed by Dr. Lee Ellis of the National Research Council (NRC) in Halifax, Nova Scotia, CANADA. GB Sciences' PD formulations were able to reduce behavioral changes associated with the loss of dopamine-producing neurons, which underlies the pathology of Parkinson's disease in the animal model. The final phase of testing will study the mechanism of action for these promising formulations, which could potentially help patients with this debilitating disease. The combined direct and indirect costs associated with Parkinson's disease are estimated at $52 billion in the U.S. alone.
"Several of GB Sciences' mixtures were effective. In fact, our most effective mixture was able to 'rescue' the PD-like behavioral changes to the point where the treated animal's behavior was back to baseline. In addition, our PD formulas produced negligible side effects, which is equally important," said Dr. Andrea Small-Howard, Chief Science Officer and Director of both GB Sciences, Inc. and GBS Global Biopharma, Inc. "These important preclinical results will be included as 'proof of concept' in GB Sciences' Investigational New Drug application with US FDA in order to enter into our 'First-in-Man' human clinical trial as early as next year."
Central to the development of Parkinson's disease is the loss of dopamine-producing neurons. Reduced dopamine levels in the brain lead to movement disorders. GB Sciences' PD formulations may be protecting dopamine-producing neurons, or they may cause the surviving neurons to produce more dopamine to compensate for a loss in the number of dopamine-producing neurons. The final phase of GB Sciences' preclinical study will examine these and other possible mechanisms for their effectiveness.
"These positive preclinical results suggest that our cannabinoid-containing complex mixtures may be useful for the treatment of Parkinson's disease symptomology," said Dr. Michael Farley, President and Director of GBS Global Biopharma. "We look forward to bringing these promising formulations into human clinical trials as early as 2020."
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