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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
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.
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.
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."
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.
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.
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
We encourage our shareholders to visit: or Twitter: @OdysseyHealth1.
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.
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.
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
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.
环球通讯社,2022年8月10日,内华达州拉斯维加斯--致力于开发独特的、改善生活的医疗产品的奥德赛健康公司(场外交易代码:ODYY)今天宣布,其第一阶段临床试验的多天递增剂量(MAD)臂的完成和安全性发现。奥德赛的试验是将其治疗脑震荡的新药PRV-002用于健康受试者。MAD Cohort I受试者连续服药5天。在这个队列中,药物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.
这项试验由领先的临床研究机构Avance Clinic Pty Ltd通过在澳大利亚拥有多个站点的第一阶段临床试验提供商Nucleus Network进行。MAD的队列I包括8名健康志愿者,他们连续5天接受一次低剂量的鼻腔注射PRV-002,然后评估异常反应。没有发现严重的不良反应,因为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."
奥德赛健康公司的雅各布·范兰丁汉博士评论说:“作为PRV-002脑震荡治疗药物开发的负责人,我非常高兴看到这些连续数天给药的积极安全结果。PRV-002在鼻内给药时似乎耐受性良好。如果在2/3期试验中发现PRV-002对脑震荡患者有效,我相信鼻内脑靶向治疗将是其成功的关键。到目前为止,鼻腔药物/装置组合运行良好,在临床环境中耐受性良好。”
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.
脑震荡代表着一种“未得到满足”的医疗需求。脑震荡的常见环境包括接触性体育赛事、军事训练和手术、机动车事故和跌倒导致的老年人辅助生活设施。
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期临床试验正在进行中,共有16名健康受试者参加。第一阶段单次递增给药(SAD)臂已经成功完成,耐受性良好。奥德赛将报告更多的MAD结果,因为它们是可用的。
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
关于奥德赛健康公司(前身为奥德赛国际集团)
奥德赛健康公司(场外交易代码:ODYY)是一家专注于拯救生命的医疗解决方案领域的医疗公司。奥德赛的公司使命是创造、收购和开发独特的资产、知识产权和特殊技术,提供有意义的医疗解决方案。该公司专注于具有公认的技术优势、提供卓越的临床实用价值和具有重大市场机会的领域。欲了解更多信息,请访问该公司网站:
We encourage our shareholders to visit: or Twitter: @OdysseyHealth1.
我们鼓励我们的股东访问: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.
关于PRV-002
PRV-002是一种完全合成的非自然产生的神经类固醇,正在开发用于治疗脑震荡。在临床前研究中,PRV-002已经证明了与相关神经类固醇相比,即使不是更好,也有同等的神经保护作用。脑震荡的动物模型表明,PRV-002可以减少与脑损伤症状相关的行为病理,如记忆障碍、焦虑和运动/感觉表现。此外,PRV-002是亲脂性的,可以很容易地穿过血脑屏障,在恢复正常血液流动的同时,迅速消除大脑中的肿胀、氧化应激和炎症。
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.
前瞻性陈述
本新闻稿可能包含1995年私人证券诉讼改革法中“安全港”条款所指的前瞻性陈述。此类陈述是基于我们目前的预期,仅代表截至本文发布之日的情况。由于各种因素和不确定因素,我们的实际结果可能与任何前瞻性陈述中所表达的大不相同,这些不确定因素包括我们继续筹集所需资金的能力,成功完成第一阶段试验的能力,我们成功开发产品的能力,我们市场的快速变化,对我们未来产品的需求变化,以及立法、法规、竞争发展和总体经济状况。
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
查询:
奥德赛健康
电子邮箱:Info@odyseyHealth Thinc.com
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在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
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在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
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