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Odyssey Health, Inc. Provides Recap on Concussion Drug Development

Odyssey Health, Inc. Provides Recap on Concussion Drug Development

奧德賽健康公司提供關於震盪藥物開發的綜述
GlobeNewswire ·  2022/10/06 08:36

Las Vegas, Nevada, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today presents a recap of their concussion drug development program. Concussions represent an 'unmet' medical need and affect millions worldwide. Repetitive concussions can increase the risk of developing Chronic Traumatic Encephalopathy (CTE) and other neuropsychiatric disorders.

內華達州拉斯維加斯,2022年10月6日(環球網)--奧德賽健康公司(場外交易代碼:ODYY),F/K/a奧德賽集團國際公司,一家專注於開發獨特的、增強生命的醫療產品的公司,今天簡要介紹了他們的腦震盪藥物開發計劃。腦震盪代表着一種未得到滿足的醫療需求,影響着全球數百萬人。反覆腦震盪會增加患慢性創傷性腦病(CTE)和其他神經精神疾病的風險。

Odyssey acquired the intellectual property and all rights to the drug on March 1, 2021. Since the acquisition Odyssey has made significant progress in the development program. Some key success points are: 

奧德賽於2021年3月1日獲得了該藥物的知識產權和所有權利。自收購以來,奧德賽在開發計劃方面取得了重大進展。一些關鍵的成功之處在於:

  • Successful completion of the pre-clinical toxicology program.
  • Successfully completed IND enabling safety studies for a Phase I human trial.
  • Created a Scientific Advisory Board of renowned medical doctors who evaluated our drug technology, pre-clinical studies and are overseeing the clinical trials.
  • Successful development of a nanoparticle drug formulation.
  • Successful development of a spray-dried formulation for intranasal delivery with our partner Upperton Ltd based in the UK.
  • Successful development and GMP manufacture of a novel breath-propelled intranasal delivery device with our partner, Design Catapult, Inc.
  • The novel breath-propelled intranasal delivery device proved successful in the Phase I trial.
  • Filed a patent application on the unique breath-propelled intranasal delivery device.
  • Contracted with world-class contract research organizations, Avance Clinical Pty, Ltd. and Nucleus Networks to conduct the Phase I human trial.
  • Obtained Alfred Ethics Board approval of an Investigators Brochure to conduct the clinical trial.
  • Successful submission of clinical trial protocols to clinicaltrials.gov.
  • Ongoing drug stability of the drug in the intranasal device without degradation.
  • Successfully completed the Phase I human clinical trial proving the drug is safe and well tolerated.
  • Created a Military Advisory Board with distinguished military veterans to assist us in selecting military sites for Phase II clinical trial.
  • 圓滿完成臨牀前毒理學項目。
  • 成功地完成了第一階段人體試驗的IND啟用安全性研究。
  • 創建了一個由知名醫生組成的科學顧問委員會,他們評估我們的藥物技術、臨牀前研究並監督臨牀試驗。
  • 成功開發了一種納米藥物配方。
  • 與總部設在英國的合作伙伴Upperton Ltd成功開發了用於鼻腔給藥的噴霧乾燥配方。
  • 與我們的合作伙伴Design Catapult,Inc.成功開發和GMP製造了一種新型的呼吸推進鼻腔給藥裝置。
  • 這種新型的呼吸推進鼻腔給藥裝置在第一階段試驗中被證明是成功的。
  • 為這種獨特的呼吸推進鼻腔給藥裝置申請了專利。
  • 與世界級合同研究機構、Avance Clinic Pty,Ltd.和Nucleus Networks簽訂合同,進行第一階段人體試驗。
  • 獲得Alfred道德委員會批准進行臨牀試驗的研究人員手冊。
  • 成功地將臨牀試驗方案提交給臨牀試驗網站。
  • 藥物在鼻腔裝置中的持續藥物穩定性,而不會降解。
  • 成功地完成了第一階段的人體臨牀試驗,證明該藥物是安全的和耐受性良好的。
  • 創建了一個由傑出退伍軍人組成的軍事顧問委員會,以幫助我們為第二階段臨牀試驗選擇軍事地點。

Odyssey is currently communicating with the FDA to present the findings from the Phase I trial. Phase II trial sites are being identified and study design is being created with the site's medical leadership and the Odyssey Medical Advisors.

奧德賽目前正在與FDA溝通,以公佈I期試驗的結果。第二階段試驗地點正在確定,研究設計正在與該地點的醫療領導和奧德賽醫療顧問一起創建。

According to Grandview Research, the global market for concussion treatment was valued at $6.9 billion in 2020 and is forecasted to reach $8.9 billion by 2027. Common settings for concussion include contact sports, military training and operations, motor vehicle accidents, children at play and elderly assistive-living facilities due to falls.

根據Granview Research的數據,2020年全球腦震盪治療市場的價值為69億美元,預計到2027年將達到89億美元。腦震盪的常見環境包括接觸性運動、軍事訓練和手術、機動車事故、兒童遊戲和因跌倒而導致的老年人輔助生活設施。

About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in the area of life-saving medical solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company's website at

關於奧德賽健康公司(前身為奧德賽國際集團)
奧德賽健康公司(場外交易代碼:ODYY)是一家專注於拯救生命的醫療解決方案領域的醫療公司。奧德賽的公司使命是創造、收購和開發獨特的資產、知識產權和特殊技術,提供有意義的醫療解決方案。該公司專注於具有公認的技術優勢、提供卓越的臨牀實用價值和具有重大市場機會的領域。欲瞭解更多信息,請訪問該公司網站:

We encourage our shareholders to visit our corporate social media accounts for updates:

我們鼓勵我們的股東訪問我們的企業社交媒體帳户以獲取最新消息:

About Our Drug Candidate
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.

關於我們的毒品候選人
PRV-002是一種完全合成的非自然產生的神經類固醇,正在開發用於治療腦震盪。在臨牀前研究中,PRV-002已經證明瞭與相關神經類固醇相比,即使不是更好,也有同等的神經保護作用。腦震盪的動物模型表明,PRV-002可以減少與腦損傷症狀相關的行為病理,如記憶障礙、焦慮和運動/感覺表現。此外,PRV-002是親脂性的,可以很容易地穿過血腦屏障,在恢復正常血液流動的同時,迅速消除大腦中的腫脹、氧化應激和炎症。

About Our Drug-Device Combination

關於我們的藥物-設備組合

The drug formulation is designed to be administered into the upper chamber of the nasal cavity immediately after the diagnosis of concussion, using the company's proprietary intranasal delivery device for periaxonal flow to the brain along the olfactory nerve. This route of administration, coupled with the drug's lipophilic characteristics, enables PRV-002 to cross the blood-brain barrier within minutes and spread throughout the brain quickly, and is intended to reverse the harmful effects of a concussion.  

該藥物配方旨在腦震盪診斷後立即進入鼻腔上腔,使用該公司專有的鼻內給藥裝置,沿着嗅神經將軸突周圍流動到大腦。這種給藥途徑,再加上藥物的親脂特性,使PRV-002能夠在幾分鐘內穿過血腦屏障,迅速傳播到整個大腦,旨在逆轉腦震盪的有害影響。

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 Phase I 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.

前瞻性陳述
本新聞稿可能包含1995年私人證券訴訟改革法中“安全港”條款所指的前瞻性陳述。此類陳述是基於我們目前的預期,僅代表截至本文發佈之日的情況。由於各種因素和不確定因素,我們的實際結果可能與任何前瞻性陳述中所表達的大不相同,這些不確定因素包括我們繼續籌集所需資金的能力,成功完成第一階段試驗的能力,我們成功開發產品的能力,我們市場的快速變化,對我們未來產品的需求變化,以及立法、法規、競爭發展和總體經濟狀況。

Inquiries:
Odyssey Health
info@odysseyhealthinc.com

查詢:
奧德賽健康
電子郵箱:Info@odyseyHealth Thinc.com


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