IRVINE, CA, Feb. 11, 2022 — McapMediaWire — Odyssey Health, Inc. f/k/a Odyssey Group International, Inc. (OTC Pink: ODYY) today announced the continued enrollment of its first in kind human clinical trial of its proprietary drug compound intended to treat concussion.
NFL Hall of Fame Quarterback Brett Favre is one of the high-profile personalities having made headlines for his push to improve concussion treatments and protocols in the NFL, as well as other contact sports around the world.
Clinical trials are currently being administered by Nucleus Network at their Melbourne, Australia clinic for an innovative medication to treat concussion developed by Odyssey Health, Inc. f/k/a Odyssey Group International, Inc. with Favre involved in the company developing the concussion treatment as a sports advisory board member. While Favre won’t be one of the volunteers in the Phase 1 trial, he is involved in overseeing the process of evaluating the treatment.
Odyssey Health, Inc. – a medical company focused on developing unique, life-saving medical products – have developed the drug candidate PRV-002 to treat concussion as a novel neurosteroid which can be inhaled through the nose as a powder with pre-clinical data suggesting it can reduce the seriousness of a concussion by reducing brain swelling, maintaining blood flow to affected areas of the brain, and potentially reducing cell death in the brain if administered early.
Dr Philip Ryan, Principal Investigator at Nucleus Network notes: “The potential benefits of an easily-administered concussion treatment are enormous. We are excited to be evaluating this treatment, especially with Australia’s passion around sports in general and contact sports in particular has brought concussion and related injuries into the national discussion. The effects of concussion remain a significant concern to people who participate in those sports and their families.”
Concussion and brain injury has become a major talking point in sport in recent years. Ex-NFL players have spoken out about the long-term effects of repeated concussions. A new development has the potential to reduce the impact of concussion, with a simple, easy-to-use treatment that can be kept in a simple first-aid kit, which could be used in sports, motor accidents, or even by the military.
In the USA, the Centers for Disease Control (CDC) estimate that there are between 1.6 and 3.8 million sports-related concussions annually in the US, and 230,000 require hospitalization. Australia has a similar rate, with more than 20,000 hospital admissions due to concussions per year.
Scientific and medical journals have written many reports on the effect of concussions in sport, both at a professional and amateur level, with major concern given to the long-term effects of repeated concussions leading to serious conditions such as Chronic traumatic encephalopathy (CTE). The impact of concussion and TBI has also been noted by many health organizations, including the Australian Government, with $50 million invested in The Traumatic Brain Injury Mission, a research funding program aimed at improving patient recovery after brain injury.
Favre highlights: “In my 19 years of playing, I’d take 20-30 hits per game. There wasn’t one game that I can remember that I didn’t have my bell rung. Seeing stars or fireworks back then was just part of the game. Now, there are protocols for concussion to try and alleviate the problem, but there isn’t a treatment available yet to reduce the impact. Changing in rules to protect players and improve protection equipment is helpful, but as players become bigger, faster and stronger, the hits get harder. The guys playing now are much bigger and faster than they have ever been before.”
“It’s not just people who play contact sports that suffer from it though,” he adds. “It is very common in the military, in car accidents, even just slipping on an icy sidewalk can give you a concussion that can impact your life. There’s no real treatment available at the moment, so when there’s a promising treatment that could help, such as Odyssey’s PRV-002, I’m hopeful that it will help take away some of the consequences of CTE and other brain injuries.”
Convenience of the treatment
With rapid treatment being a key factor in reducing the severity of a brain injury, being able to administer the medication quickly, effectively, and safely is critical. The delivery method is a unique dosing device that allows an individual to blow the powder into their own nasal cavity.
The design of the device was an important challenge in the development of this product, with the goal that it should be easily stored and administered in urgent situations, such as motor vehicle accidents or sporting injuries.
To use the device, the safety cap is removed, and the device is inserted into a single nostril at one end and in the mouth at the other (as indicated on the device). Intranasal delivery is performed by sharply exhaling through the device.
An innovative approach to concussion treatment
Other than pain relief and anti-depressants, there are currently no approved pharmacological therapies for TBI (concussion).
The PRV-002 medication is derived from naturally occurring steroids that stimulate the brains of males and females. It has been used safely in humans for several different conditions. The novel way of administering PRV-002 allows for a safer and faster method of delivery, as well as convenient storage in medical kits that can be carried by emergency services or appropriate medical staff at sporting events.
Jacob VanLandingham, Ph.D., Executive VP of Drug Development of Odyssey Group International enthused: “We are so excited about enrolment for our human trials and to establish a strong safety profile following PRV-002 nasal application. These studies will look at pharmacokinetics and drug tolerability at three dosage strengths. The most tolerated dose will be used in the subsequent trials to determine efficacy.”
“We are so excited to be running our clinical trials for the first concussion pharmaceutical treatment in Australia. The Nucleus Network and Avance Clinical teams are incredible partners. Combatting brain inflammation early on will help protect the brains of our youth athletes,” said Brett Favre.
The trial is a double-blind, placebo-controlled study of healthy participants, administered through Nucleus Network’s Melbourne site.
For more information on Nucleus Network, go to https://www.nucleusnetwork.com/us/
For more information on the Odyssey Health, Inc. f/k/a Odyssey Group International, Inc. go to odysseygi.com
About Odyssey Health, Inc. (formerly Odyssey Group International. Inc.)
Odyssey Health, Inc. f/k/a Odyssey Group International, Inc. (OTC Pink: ODYY) is a technology company with a focus in the area of life saving medical solutions. Odyssey’s corporate mission is to create, acquire and accumulate distinct medical 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, and have a substantial market opportunity.
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.
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 1 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.
Odyssey Health, Inc. f/k/a Odyssey Group International, Inc.