Odyssey Group International Reports Achieving Drug Safety Standards for Clinical Trials of its Drug for Treating Concussion
Odyssey Group International (OTCQB: ODYY) announced the successful completion of final safety studies and cellular safety assays for its drug PRV-002, aimed at treating concussions. With a favorable review indicating no significant cardiac risk or mutagenesis, the drug is set for a final safety evaluation by the Clinical Trial Ethics Committee before human trials begin. The nasal applicator device met quality control standards, showing no contamination. PRV-002 has shown promising preclinical results, indicating potential neuroprotective effects and ability to address brain injury symptoms.
- Completion of final safety studies for PRV-002, allowing progression to human trials.
- No significant cardiac liability or mutagenesis found in safety tests.
- Successful quality control tests for the nasal applicator device.
- None.
IRVINE, CA, June 29, 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 successful completion of their final system safety studies and cellular safety assays for entering clinical trials to treat concussion. The Company’s drug, PRV-002, will now receive a final safety review by the Clinical Trial Ethics Committee.
“Safety is of the utmost importance when performing a clinical trial with a novel drug compound. We are comfortable and excited to move forward into the clinic now that we have demonstrated how safe PRV-002 is across the board,” commented Jacob VanLandingham, Executive VP of Drug Development of Odyssey Group International.
The cardiac receptor, hERG, which maintains electrical homeostasis was assayed with PRV-002. Findings showed no significant cardiac liability at proposed concussion treatment concentrations. Further there was no appreciable mutagenesis or cancer-like activity when evaluating PRV-002 using the Ames Test at clinically defined treatment concentrations. Additionally, respiratory toxicology testing was done in rodents with results showing no effect of PRV-002 on Respiratory Rate, Tidal Volume or Minute Volume.
In a separate test of the nasal applicator device, established quality control protocols proved effective with no bacterial or viral contamination.
“Combined, these safety findings are very favorable for PRV-002 as a clinical trial drug candidate” commented Michael Redmond, CEO. The Odyssey Group International concussion drug development program can now receive its final safety review by the Ethics Committee to move forward into human 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 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.
For more information, visit: http://www.odysseygi.com
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 close on the agreement in a timely manner, successfully complete a Phase 1 clinical trial, the economic slowdown affecting companies, 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
What is the purpose of PRV-002 by Odyssey Group International?
What safety studies were completed for PRV-002?
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How does PRV-002 work in treating concussions?
