Odyssey Group International Completes Final Drug-Device Combination Product in Preparation for Clinical Trial Launch
Odyssey Group International (OTC: ODYY) has successfully developed a novel drug-device combination product aimed at treating concussions, completing its formulation for human clinical trials. The product, which can be administered as a spray-dried powder via the nasal cavity, targets brain swelling and oxidative stress post-concussion. Certified by Upperton Limited, the product is prepared for Phase 1 trials. Executive VP Jacob VanLandingham emphasized increased drug efficacy with reduced side effects. The company aims to make significant advancements in medical solutions while addressing substantial market opportunities.
- Successful completion of a drug-device combination product for concussion treatment.
- Optimized formulation is expected to enhance drug efficacy and safety.
- Preparation for Phase 1 clinical trials indicates progress in product development.
- Potential risks related to the ethics committee review process before trials.
- Dependence on raising funds for continued development and trials.
IRVINE, CA, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Odyssey Group International, Inc. (OTC:ODYY) (the "Company" or "Odyssey"), a technology and asset acquisition company focused on developing unique medical products, today announced the successful completion of their novel drug-device combination product to be administered in human clinical trials for treating concussion.
After sustaining a concussion there is brain swelling, inflammation and oxidative stress. Odyssey has developed a drug formulation designed to reduce this harmful response. The drug formula can be given via breath propulsion into the nose. As a spray-dried powder formulation, the active drug can be dispersed throughout the upper portion of the nasal cavity without being inhaled or swallowed. The drug-device combination allows for the drug to travel upward along the cranial nerves used for smell and is delivered directly into the traumatized brain.
The final powdered formula has been completed and certified by Upperton Limited, a GMP drug manufacturer based in the UK. Particle size to be dispersed from the device has been defined. Upperton is now filling, packaging and labeling the drug-device combination product in preparation for Odyssey’s Phase 1 clinical trial.
“By developing our drug formulation in powder form we can ensure all regions of the nasal cavity are exposed thus increasing the amount absorbed into the brain. We believe this novel formulation will not only lead to greater drug efficacy but with our targeted approach reduce exposure and any potential side effects to other organs of the body.” commented Jacob VanLandingham, Executive VP of Drug Development of Odyssey Group International.
“We are excited that we have been able to optimize and begin manufacturing Odyssey’s concussion drug formula for human trials. Our expertise in manufacturing drugs into spray-dried powder form is used to maximize drug performance and safety. It’s exciting to be involved in such a novel drug administration design.” Said Paul Kelsall, Director of Clinical Manufacturing, Upperton Limited, Inc.
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-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.
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 ethics committee review process, 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.
FAQ
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