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Odyssey Health, Inc. Announces Positive Results from Its Phase I Multi-Day Ascending Dosing for the Treatment of Concussion

Odyssey Health, Inc. Announces Positive Results from Its Phase I Multi-Day Ascending Dosing for the Treatment of Concussion

奧德賽健康公司宣佈其治療腦震盪的第一階段多天遞增劑量取得積極結果
GlobeNewswire ·  2022/08/10 08:11

Las Vegas, NV, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-improving medical products, today announces the completion and safety findings from Cohort I of its Multi-Day Ascending Dosing (MAD) arm for its Phase I Clinical Trial. Odyssey's trial is administering PRV-002, its novel drug to treat concussion, to healthy human subjects. MAD Cohort I subjects were dosed for five consecutive days. The drug, PRV-002 was safe and well tolerated in this cohort.

環球通訊社,2022年8月10日,內華達州拉斯維加斯--致力於開發獨特的、改善生活的醫療產品的奧德賽健康公司(場外交易代碼:ODYY)今天宣佈,其第一階段臨牀試驗的多天遞增劑量(MAD)臂的完成和安全性發現。奧德賽的試驗是將其治療腦震盪的新藥PRV-002用於健康受試者。MAD Cohort I受試者連續服藥5天。在這個隊列中,藥物PRV-002是安全的,耐受性很好。

The trial is being conducted by a leading clinical research organization, Avance Clinical Pty Ltd, through Nucleus Network, a Phase 1 clinical trial provider with multiple sites throughout Australia. Cohort I of MAD included eight healthy human volunteers that received one low dose of intranasal PRV-002 for five consecutive days followed by evaluations for abnormal responses. No severe adverse events were noted as PRV-002 appeared to be well-tolerated.

這項試驗由領先的臨牀研究機構Avance Clinic Pty Ltd通過在澳大利亞擁有多個站點的第一階段臨牀試驗提供商Nucleus Network進行。MAD的隊列I包括8名健康志願者,他們連續5天接受一次低劑量的鼻腔注射PRV-002,然後評估異常反應。沒有發現嚴重的不良反應,因為PRV-002似乎耐受性良好。

Dr. Jacob VanLandingham of Odyssey Health, Inc. commented, "As the head of drug development for the PRV-002 concussion treatment, I was very happy to see these positive safety results when dosing for multiple days. PRV-002 appears to be well-tolerated when given intranasally. If PRV-002 is found to be efficacious for concussed patients in the Phase 2/3 trials, I believe that intranasal brain-targeting will be the key to its success. So far, the intranasal drug/device combination has functioned nicely and has been well-tolerated in the clinical setting."

奧德賽健康公司的雅各布·範蘭丁漢博士評論説:“作為PRV-002腦震盪治療藥物開發的負責人,我非常高興看到這些連續數天給藥的積極安全結果。PRV-002在鼻內給藥時似乎耐受性良好。如果在2/3期試驗中發現PRV-002對腦震盪患者有效,我相信鼻內腦靶向治療將是其成功的關鍵。到目前為止,鼻腔藥物/裝置組合運行良好,在臨牀環境中耐受性良好。”

Concussions represent an 'unmet' medical need. Common settings for concussion include contact sporting events, military training and operations, motor vehicle accidents and elderly assistive-living facilities due to falls.

腦震盪代表着一種“未得到滿足”的醫療需求。腦震盪的常見環境包括接觸性體育賽事、軍事訓練和手術、機動車事故和跌倒導致的老年人輔助生活設施。

The Phase I MAD clinical trial is ongoing and consists of a total of 16 healthy subjects. The Phase I Single Ascending Dosing (SAD) arm has successfully been completed and was well-tolerated. Odyssey will report additional MAD results as they become available.

MAD的I期臨牀試驗正在進行中,共有16名健康受試者參加。第一階段單次遞增給藥(SAD)臂已經成功完成,耐受性良好。奧德賽將報告更多的MAD結果,因為它們是可用的。

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: or Twitter: @OdysseyHealth1.

我們鼓勵我們的股東訪問:或Twitter:@OdyseyHealth1。

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.

關於PRV-002
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。

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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