- Medical product developer Odyssey Health Inc. is dedicated to creating solutions for a variety of life-quality situations, such as early detection of heart disease, saving choking victims and treating nervous system ailments
- Odyssey Health’s primary focus has been advancing its combined device and drug solution for brain concussion injuries through the clinical test process to commercial fulfillment
- The therapeutic solution, currently known as PRV-002, is designed to deliver a synthetic neurosteroid to injured brain tissue, where it can reduce swelling and sustain needed blood flow
- The company’s human testing has demonstrated safety with “no serious adverse events,” and Odyssey is preparing Phase II testing in cooperation with military service personnel to better establish the drug’s effectiveness
Odyssey Health (OTC: ODYY) is a U.S. company dedicated to developing medical solutions to select conditions that affect people’s quality of life. Odyssey has been making headway on preparing a number of products for commercial marketability, such as a device to remove a throat obstruction in a choking person, new technology for the early detection for heart disease, and a potential solution for the neuro-degenerative Niemann-Pick disease.
The company’s most developed product to date is a solution for treating brain concussions at their earliest stage — a drug-device combination technology that stands to benefit a wide segment of society, from athletes in school and professional settings to elderly fall victims. The military is also taking an interest in Odyssey’s product given the propensity for mild brain injury (“mTBI”) among its service personnel.
The technology, PRV-002, is undergoing Phase I testing to establish its safety in human patients following preliminary trials using lab animals, and on Sept. 13 Odyssey announced the successful completion of safety measures for the second cohort of their Phase I Multi-Day Ascending Dosing (“MAD”) clinical trial.
“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,” Odyssey Health CEO Michael Redmond stated in the announcement (https://ibn.fm/1njEi). “I’m equally pleased that the intranasal drug/device combination has functioned nicely and has been easy to operate in the clinical setting.”
PRV-002 uses an applicator to administer a synthetic neurosteroid into the nasal cavity, where the neurosteroid drug can be taken up into the brain through mucosal tissues. While brain injuries and illnesses are typically difficult to treat because of the body’s protective brain-blood barrier, PRV-002’s lipophilic quality helps it cross the barrier that bars entry to other drugs’ molecules.
Within the central nervous system, the drug is able to directly and rapidly target swelling and oxidative stress resulting from concussive injuries in order to sustain optimal blood flow to the brain.
Concussions can have significant consequences in a patient’s cognitive function and emotional stability, but they remain an “unmet medical need” because of the lack of an immediately responsive pharmaceutical. Patients are generally just advised to rest and take pain relievers.
Sixteen healthy individuals have participated in Odyssey’s Phase I trial — eight in the low-dose cohort and the remainder in the follow up high-dose cohort. The company is now selecting clinical sites and developing the Investigator’s Brochure for the Phase II trial, expected to not only establish PRV-002’s safety but also that it is demonstrably effective in treating concussed patients.
Military service member volunteers are expected to participate in the next stage of the testing.
“We are actively identifying and assisting with Phase II military trial site setup,” Major General (Ret.) Jim Linder, the former chief of staff for the U.S. Special Operations Command, stated in a July 12 news release about the program (https://ibn.fm/DczCh). “We need a treatment to prevent the long-term consequences of concussion as far too many of our Service Members are retiring with TBI disorders that lessen their quality of life.”
For more information, visit the company’s website at www.OdysseyHealthInc.com.
NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://ibn.fm/ODYY
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