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Nexien BioPharma to File Pre-IND Meeting Request with the FDA
Nexien BioPharma to File Pre-IND Meeting Request with the FDA.
About this update from Nexien Biopharma, Inc.
[{"type":"text","content":"\n \n Nexien BioPharma, Inc. (“Nexien” or the “Company”) (OTCQB: NXEN), a next \n generation biopharmaceutical company focused on research, development \n and commercialization of novel FDA-compliant cannabinoid pharmaceuticals \n and related drug delivery systems, today announced encouraging results \n of clinical observations of patient groups consisting of patients \n suffering from non-dystrophic myotonia and myotonic dystrophies (DM) \n type 1 and 2, indicating that specific cannabinoid formulations are \n supportive in relief of myotonia and DM symptoms. Nexien intends to \n proceed with related clinical studies in accordance with U.S. Food and \n Drug Administration (FDA) protocols, commencing with the filing of a \n Pre-IND meeting request.\n \n \n Parallel to ongoing clinical observations, Dr. Benedikt Schoser at the \n University of Munich, a Nexien scientific advisor and leading myotonic \n dystrophy expert, and The Myotonic Dystrophy Foundation in the United \n States each conducted questionnaires with patients suffering from DM \n type 1 and DM type 2. The purpose of the questionnaires was to determine \n patient perspectives on the effects of naturally occurring cannabinoids \n and whether these specific effects resulted in symptom relief. The \n results of both questionnaires in the United States and Germany were \n positive and suggested further exploration is warranted. Dr. Schoser´s \n team, along with DM organizations in the United States and Germany, \n published the results of this preliminary questionnaire in the Journal \n of Neurology: “Cannabis use in myotonic dystrophy patients in Germany \n and USA: a pilot survey.”1\n \n \n Concurrently, based on ongoing clinical observations in DM1 and DM2 \n patients, as well as the results of the questionnaires, Nexien and Dr. \n Schoser are preparing protocols to commence pre-clinical and clinical \n studies.\n \n \n Alex Wasyl, Nexien’s Chief Executive Officer, stated, “The results of \n the clinical observations reinforced by the patient questionnaires \n support the use of specific cannabinoid formulations in the treatment of \n myotonia, and DM1 and DM2 symptoms. Based on these outcomes and \n significant anecdotal evidence, Nexien will work toward filing a Pre-IND \n Meeting Request with the FDA to commence...