Odyssey Health Achieves Positive Safety Outcomes for Concussion Drug in Multiple Ascending Dosing Trial, Cohort II
Las Vegas, NV, Sept. 13, 2022 (GLOBE NEWSWIRE) — Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today announced the successful completion of safety measures for the second cohort of their Phase I Multi-Day Ascending Dosing (MAD) clinical trial. Odyssey’s trial involves administering PRV-002, the Company’s novel drug to treat concussion, to healthy human subjects to determine drug safety. For all cohorts of the trial, the drug was found to be safe and well tolerated.
The Phase I MAD clinical trial consists of a total of 16 healthy subjects. In Cohort I, eight patients received a low dose of drug and in Cohort II, patients received a high dose of drug. In both cohorts the drug was well tolerated and safe with no severe adverse events reported.
Michael Redmond, CEO of Odyssey Health, Inc. commented, “At double the dose of the previous cohort we saw no serious adverse events. As we come close to completing the Phase I trial, I am very pleased with the safety profile of our concussion pharmaceutical treatment, PRV-002. I’m equally pleased that the intranasal drug/device combination has functioned nicely and has been easy to operate in the clinical setting.”
Odyssey is currently selecting clinical sites and developing the Investigator’s Brochure for the Phase II trial. Concussions represent an ‘unmet’ medical need and affect millions worldwide. Repetitive concussions can lead to rapid cognitive decline and emotional lability.
The global market for concussion treatment was valued at $6.9 billion in 2020 and is forecasted to reach $8.9 billion by 2027, according to Grandview Research.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in the area of life-saving medical solutions. Odyssey’s corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company’s website at www.odysseyhealthinc.com
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About PRV-002
PRV-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion). In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
About Nucleus Network
Nucleus Network is the only multi-site Phase 1 clinical trials provider located in Australia and the USA. Nucleus Network provides high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, their cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence, and research expertise.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete the Phase I trial, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.
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info@odysseyhealthinc.com
