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Odyssey Health, Inc. Provides Recap on Concussion Drug Development

Odyssey Health, Inc. Provides Recap on Concussion Drug Development

奥德赛健康公司提供关于震荡药物开发的综述
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.

内华达州拉斯维加斯,2022年10月6日(环球网)--奥德赛健康公司(场外交易代码:ODYY),F/K/a奥德赛集团国际公司,一家专注于开发独特的、增强生命的医疗产品的公司,今天简要介绍了他们的脑震荡药物开发计划。脑震荡代表着一种未得到满足的医疗需求,影响着全球数百万人。反复脑震荡会增加患慢性创伤性脑病(CTE)和其他神经精神疾病的风险。

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: 

奥德赛于2021年3月1日获得了该药物的知识产权和所有权利。自收购以来,奥德赛在开发计划方面取得了重大进展。一些关键的成功之处在于:

  • 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.
  • 圆满完成临床前毒理学项目。
  • 成功地完成了第一阶段人体试验的IND启用安全性研究。
  • 创建了一个由知名医生组成的科学顾问委员会,他们评估我们的药物技术、临床前研究并监督临床试验。
  • 成功开发了一种纳米药物配方。
  • 与总部设在英国的合作伙伴Upperton Ltd成功开发了用于鼻腔给药的喷雾干燥配方。
  • 与我们的合作伙伴Design Catapult,Inc.成功开发和GMP制造了一种新型的呼吸推进鼻腔给药装置。
  • 这种新型的呼吸推进鼻腔给药装置在第一阶段试验中被证明是成功的。
  • 为这种独特的呼吸推进鼻腔给药装置申请了专利。
  • 与世界级合同研究机构、Avance Clinic Pty,Ltd.和Nucleus Networks签订合同,进行第一阶段人体试验。
  • 获得Alfred道德委员会批准进行临床试验的研究人员手册。
  • 成功地将临床试验方案提交给临床试验网站。
  • 药物在鼻腔装置中的持续药物稳定性,而不会降解。
  • 成功地完成了第一阶段的人体临床试验,证明该药物是安全的和耐受性良好的。
  • 创建了一个由杰出退伍军人组成的军事顾问委员会,以帮助我们为第二阶段临床试验选择军事地点。

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.

奥德赛目前正在与FDA沟通,以公布I期试验的结果。第二阶段试验地点正在确定,研究设计正在与该地点的医疗领导和奥德赛医疗顾问一起创建。

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.

根据Granview Research的数据,2020年全球脑震荡治疗市场的价值为69亿美元,预计到2027年将达到89亿美元。脑震荡的常见环境包括接触性运动、军事训练和手术、机动车事故、儿童游戏和因跌倒而导致的老年人辅助生活设施。

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

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 our corporate social media accounts for updates:

我们鼓励我们的股东访问我们的企业社交媒体帐户以获取最新消息:

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.

关于我们的毒品候选人
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。

About Our Drug-Device Combination

关于我们的药物-设备组合

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.  

该药物配方旨在脑震荡诊断后立即进入鼻腔上腔,使用该公司专有的鼻内给药装置,沿着嗅神经将轴突周围流动到大脑。这种给药途径,再加上药物的亲脂特性,使PRV-002能够在几分钟内穿过血脑屏障,迅速传播到整个大脑,旨在逆转脑震荡的有害影响。

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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