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Odyssey Group International Announces Successful Toxicology Studies for its Concussion Drug
Odyssey Group International Announces Successful Toxicology Studies for its Concussion Drug.
About this update from Odyssey Health Inc.
[{"type":"text","content":"\n IRVINE, CA, May 26, 2021 (GLOBE NEWSWIRE) -- Odyssey Group International, Inc. (OTCQB:ODYY) (the \"Company\" or \"Odyssey\"), a technology and asset acquisition company focused on developing unique, life-saving medical products, today announced the completion of the Food and Drug Administration (FDA) required toxicology studies designed to support clinical trials with PRV-002, its lead drug candidate to treat concussion (mild traumatic brain injury). Odyssey has also contracted with a Contract Research Organization (CRO) for its planned Phase 1 human trial. PRV-002 was tested in two species of laboratory animals, dosed three times per day at three escalating doses by intranasal administration for 14 days. Standard safety assessments included laboratory blood tests, urinalysis, EKG, clinical observations and detailed microscopic evaluation of all major organs. These preclinical studies demonstrated that the safety margin of PRV-002 was over 100-fold that of intended safety and efficacious dosing in clinical trials. This key data positions Odyssey to initiate human clinical testing this summer. Odyssey’s Phase 1 clinical trials will be performed in Australia with the assistance of Nucleus Network. Inc., a leading CRO. Phase 1 clinical trial data collected in Australia is accepted by the FDA and provides Odyssey a 43% rebate on trial costs from the Australian government. These data will strengthen the Company’s Investigational New Drug Application (IND) with the FDA prior to starting Phase 2 trials back in the US. Additional preclinical studies required by the FDA have either been completed, are currently ongoing or will be completed prior to the IND submission to the FDA for phase 2. “This is an important step in the development of our concussion drug and prepares us for clinical trials,” commented Michael Redmond, President and Chief Executive Officer of Odyssey Group International. “The toxicology results suggest tremendous safety related to our drug and we are excited to partner with an esteemed CRO such as Nucleus Network to move forward with the Phase 1 trials.” About Odyssey Group International, Inc.Odyssey Group International, Inc. (OTCQB:ODYY) is a technology and asset acquisition company with a focus in the area of life-saving medical solutions. Odyssey's corporate mission is to crea...