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Odyssey Group International Completes IND-enabling Studies, Submits Investigator’s Brochure for Phase 1 Clinical Trial
Odyssey Group International Completes IND-enabling Studies, Submits Investigator’s Brochure for Phase 1 Clinical Trial.
About this update from Odyssey Health Inc.
[{"type":"text","content":"\n IRVINE, CA, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Odyssey Group International, Inc. (OTC:ODYY) (the \"Company\" or \"Odyssey\"), a technology and asset acquisition company focused on developing unique, life-saving medical products, today announced the successful completion of their Investigational New Drug (“IND”) enabling studies and submission of their Investigator’s Brochure (“IB”) for Ethics Committee review to begin Phase 1 clinical trials for the first in-human treatment of concussion. “Having successfully completed our IND-enabling studies and Investigational Brochure we have taken a large step closer to launching human clinical trials for a potential treatment for this unmet medical need,” commented Jacob VanLandingham, Executive VP of Drug Development of Odyssey Group International. The IB includes the pre-clinical safety and efficacy data, the design for Phase 1 clinical trials and the informed consent to enroll subjects in the trial. Furthermore, the IB requires that IND-enabling studies be successfully completed and reported. These study areas include the following: Safety Pharmacology, Toxicology, CMC (Chemistry Manufacturing and Control) activities, ADME (Absorption, Distribution, Metabolism and Excretion) and Genotoxicity. The Ethics Committee is expected to complete their review this month. “PRV-002 continues to pass all the required steps to enter human trials. Successful completion of these IND-enabling studies provides confidence that our drug is safe, active and stable.” said Michael Redmond, CEO of Odyssey Group International About Odyssey Group International, Inc.Odyssey Group International, Inc. (OTC: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 create, acquire and accumulate distinct assets, intellectual properties, and exceptional technologies that provide meaningful medical solutions. The Company is focused on building and acquiring assets in areas that have an identified technological advantage, provide superior clinical utility, have a substantial market opportunity and provide solid returns to its valued shareholders and partners. We encourage our shareholders to visit: http://www.odysseygi.com or  Twitter: @OdysseyGroupIn1. About PRV-002PRV-002 ...