Irvine, CA, Might 05, 2022 (GLOBE NEWSWIRE) — Odyssey Well being, Inc. (OTC Pink: ODYY), f/okay/a Odyssey Group Worldwide, Inc., an organization centered on creating distinctive, life-saving medical merchandise, immediately introduced constructive outcomes from the primary group of sufferers dosed with PRV-002, of their Section I scientific trial. Odyssey’s trial is administering PRV-002, their novel drug to deal with concussion, to wholesome human topics. So far the drug has proven to be protected and nicely tolerated. Every year, there are over three million reported concussions in males, girls and youngsters in the US and over 20 million worldwide. Concussions symbolize an ‘unmet’ medical want, as there isn’t any FDA permitted remedy.
“Based mostly on our animal information and after reviewing our preliminary Section I trial security studies we’re optimistic that PRV-002 will probably be a protected possibility for the remedy of concussion. We stay up for finishing the Section I trial and presenting our findings to the FDA. Following FDA overview we intend to provoke a Section II scientific trial within the US beginning with our navy. Now we have created a navy advisory board to help with this effort.” commented Michael Redmond, CEO of Odyssey Well being, Inc.
The trial is being performed at a number one Scientific Analysis Group, Nucleus Community. Enrollment of Section I wholesome human topics is finished by means of an intense well being screening course of. Initially the topic is requested to acknowledge any recognized dangers that will have an effect on their trial efficiency. That is adopted by a full well being evaluation to determine the themes’ bodily suitability together with measurements for blood strain, coronary heart fee, lung capability, and in depth blood work evaluation.
The group reported on represents 5 wholesome topics that obtained a single dose of PRV-002. The next well being measurements had been performed: important indicators, ECG, spirometry, nasal examination, a questionnaire and sleepiness scale. There have been no critical adversarial occasions reported.
Dr. Philip Ryan of Nucleus Networks commented, “Concussion is a situation that may have many debilitating long-term results and trigger important influence within the lives of many individuals. Nucleus Community is proud to play an element in evaluating a remedy that improves our understanding of concussions and will at some point result in improved well being outcomes for victims.”
The Section I scientific trial is ongoing and consists of 48 wholesome topics. The Section I trial has a single ascending dose and a multi ascending dose element to it. Odyssey will report further outcomes as they change into obtainable.
About Odyssey Well being Inc. (previously Odyssey Group Worldwide, Inc.)
Odyssey Group Worldwide, Inc. (OTC Pink: ODYY) is a expertise and asset acquisition firm with a spotlight within the space of life saving medical options. Odyssey’s company mission is to create, purchase and accumulate distinct property, mental properties, and distinctive applied sciences that present significant medical options. The Firm is targeted on constructing and buying property in areas which have an recognized technological benefit, present superior scientific utility, have a considerable market alternative and supply stable returns to its valued shareholders and companions.
PRV-002 is a totally artificial non-naturally occurring neurosteroid being developed for the remedy of mTBI (concussion). In preclinical research, PRV-002 has demonstrated equal, if not superior, neuroprotective results in comparison with associated neurosteroids. Animal fashions of concussion demonstrated that PRV-002 reduces the behavioral pathology related to mind harm signs comparable to reminiscence impairment, nervousness, and motor/sensory efficiency. Moreover, PRV-002 is lipophilic and may simply cross the blood-brain barrier to quickly remove swelling, oxidative stress and irritation within the mind whereas restoring correct blood circulate.
About Nucleus Community
Nucleus Community is the one multi-site Section 1 scientific trials supplier positioned in Australia and the USA. Nucleus Community offers high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical firms throughout the USA, Europe and Asia. Positioned inside cutting-edge well being precincts, their cost-effective, accelerated scientific growth options are supported by superior expertise, scientific excellence, and analysis experience.
This information launch could comprise forward-looking statements throughout the which means of the “protected harbor” provisions of the Personal Securities Litigation Reform Act of 1995. Such statements are primarily based upon our present expectations and converse solely as of the date hereof. Our precise outcomes could differ materially and adversely from these expressed in any forward-looking statements because of varied elements and uncertainties, together with our means to proceed to boost wanted funds, efficiently full the part I trial, our means to efficiently develop merchandise, fast adjustments in our markets, adjustments in demand for our future merchandise, and legislative, regulatory, aggressive developments and normal financial circumstances.
Odyssey Well being, Inc. f/okay/a Odyssey Group Worldwide, Inc.