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Oragenics Appoints William "Frank" Peacock MD as Chief Clinical Officer

Oragenics Appoints William "Frank" Peacock MD as Chief Clinical Officer

Oragenics 任命医学博士 William “Frank” Peacock 为首席临床官
Oragenics ·  05/22 12:00

Oragenics Appoints William "Frank" Peacock MD as Chief Clinical Officer

Oragenics 任命医学博士 William “Frank” Peacock 为首席临床官

May 22, 2024
2024 年 5 月 22 日

Dr. Peacock to Oversee Upcoming Phase II Clinical Trial for Treating Concussion in the Emergency Department

孔雀博士将监督急诊科即将进行的治疗脑震荡的二期临床试验

SARASOTA, Fla., May 22, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. William "Frank" Peacock as its Chief Clinical Officer, who will conduct its anticipated Phase II clinical trial for treating concussion in the Emergency Department ("ED"). Oragenics' lead drug candidate, ONP-002, is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (mTBI), commonly known as concussion, in the field and emergency departments. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated.

佛罗里达州萨拉索塔,2024年5月22日(GLOBE NEWSWIRE)——专注于开发用于治疗神经系统疾病的独特鼻内药物的公司Oragenics, Inc.(纽约证券交易所美国股票代码:OGEN)今天宣布,已任命威廉· “弗兰克” · 皮科克博士为首席临床官,他将在急诊室(“ED”)进行预期的二期临床试验,用于治疗脑震荡。Oragenics的主要候选药物 ONP-002 与其鼻内设备相结合,用于在现场和急诊室治疗轻度创伤性脑损伤(mTBI),通常称为脑震荡。ONP-002 是一种新的化学实体 (NCE),旨在通过输送到鼻腔并继续输送到大脑来靶向大脑。一项40名患者的I期研究已经完成,显示该药物安全且耐受性良好。

Dr. Peacock is currently the Vice Chair for Emergency Medicine Research at Baylor College of Medicine and a past Professor at the Cleveland Clinic Lerner College of Medicine. He is also the Principal Investigator of a trial for a company developing blood biomarkers for the identification of concussion in the emergency department, which is analyzing acute blood markers that are elevated after concussion to not only ensure concussion is identified but also as a predictor of potential severity and longer-term complications. Dr. Peacock is a world-renowned speaker and researcher. He has been instrumental in the approval and use of high sensitivity blood troponins for acute coronary syndrome failure in emergency settings, which can be seen in the JAMA Cardiology publication, Efficacy of High-Sensitivity Troponin T in Identifying Very-Low-Risk Patients with Possible Acute Coronary Syndrome, and he is the editor of the first book of "Biomarkers of Traumatic Brain Injury".

孔雀博士目前是贝勒医学院急诊医学研究副主任,曾任克利夫兰诊所勒纳医学院教授。他还是一家开发用于识别急诊室脑震荡的血液生物标志物的公司的试验的首席研究员。该试验正在分析脑震荡后升高的急性血液标志物,不仅可以确保识别出脑震荡,还可以预测潜在的严重程度和长期并发症。孔雀博士是世界知名的演讲者和研究员。他在批准和使用高灵敏度血肌钙蛋白治疗急性冠状动脉综合征衰竭方面发挥了重要作用,这可以看出 JAMA 心脏病学出版物, 高灵敏度肌钙蛋白T在识别可能患有急性冠脉综合征的极低风险患者的疗效,他是《创伤性脑损伤的生物标志物》第一本书的编辑。

"I am excited to join Oragenics as its Chief Clinical Officer at such an important and pivotal time in the company's clinical program. I have been involved with concussion care in the emergency department throughout my 30-plus-year career. My role with the HeadSMART blood biomarker trial has shown me that we need biomarkers to trigger a treatment in the ER. We are searching for that treatment, and I am looking forward to testing ONP-002 to help determine if it can improve patient outcomes in our upcoming Phase II clinical trials," said Dr. Peacock.

“在公司临床项目如此重要和关键的时刻加入Oragenics担任首席临床官,我感到非常兴奋。在我30多年的职业生涯中,我一直在急诊室从事脑震荡护理工作。我在HeadSmart血液生物标志物试验中所扮演的角色向我表明,我们需要生物标志物来触发急诊室的治疗。我们正在寻找这种治疗方法,我期待测试 ONP-002,以帮助确定它是否可以在我们即将到来的二期临床试验中改善患者的预后,” 孔雀博士说。

"We are fortunate to have such an esteemed emergency medicine physician and researcher join our team in this important role at Oragenics. Given his understanding of blood biomarkers, throughout his career, his intimate knowledge in emergency medicine protocols and close ties with leading enrollment centers for TBI clinical research, we believe he will play an invaluable role in the success of Oragenics and planned Phase II trials. We are currently working with Avance Clinical, CRO, for our Phase II trial," stated Michael Redmond, President of Oragenics.

“我们很幸运有这样一位受人尊敬的急诊医学医生和研究人员加入我们的团队,在Oragenics担任这一重要职务。鉴于他在整个职业生涯中对血液生物标志物的理解、对急诊医学方案的深入了解以及与TBI临床研究的主要招生中心的密切关系,我们相信他将在Oragenics和计划中的II期试验的成功中发挥宝贵的作用。我们目前正在与CRO Avance Clinical合作进行我们的二期试验。” Oragenics总裁迈克尔·雷德蒙德说。

In preclinical animal models, ONP-002 has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. "Our Phase I human study has shown ONP-002 to be well tolerated in humans. The Phase II trial is designed to establish a time to first dose, relationships between drug application and blood biomarker levels, and the evaluation of patient symptom severity in the first few hours and days after injury," said Dr. Peacock.

在临床前动物模型中,ONP-002 已被证明可以显著改善脑损伤后的分子和行为结果。此外,该药物作为纳米颗粒的鼻内输送已被证明可以增强动物的大脑暴露和新陈代谢。“我们的 I 期人体研究表明,ONP-002 对人类具有良好的耐受性。II期试验旨在确定首次服药时间、药物应用与血液生物标志物水平之间的关系,以及评估受伤后最初几小时和几天内患者症状的严重程度,” 孔雀博士说。

Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion syndrome is linked to long-term disability and occurs in as high as 20% of concussed patients.

脑震荡是一种未得到满足的医疗需求。据估计,全球每年报告6900万起脑震荡。脑震荡的常见原因包括跌倒、机动车事故和接触性运动。其他神经系统疾病,包括阿尔茨海默氏病、帕金森氏病和慢性创伤性脑病(CTE),都与脑震荡有关。脑震荡后综合征与长期残疾有关,发生在高达20%的脑震荡患者中。

About Oragenics
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

关于 Oragenics
Oragenics是一家处于开发阶段的生物技术公司,专注于神经病学和对抗传染病药物的鼻腔输送,包括用于治疗轻度创伤性脑损伤(mtBI)(也称为脑震荡)和治疗C型尼曼·皮克病(NPC)的候选药物,以及专有的粉末配方和鼻内输送设备。欲了解更多信息,请访问 www.oragenics.com

Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company's ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company's ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company's ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company's expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

前瞻性陈述
本通信包含1995年《美国私人证券诉讼改革法》安全港条款所指的 “前瞻性陈述”,包括但不限于有关公司使用其新型药物器械组合治疗轻度创伤性脑损伤及时成功进行二期临床试验的能力的陈述。这些前瞻性陈述基于管理层的信念、假设和当前可用的信息。“相信”、“期望”、“预测”、“打算”、“估计”、“项目” 等词以及不只与历史问题相关的类似表述可识别前瞻性陈述。投资者在依赖前瞻性陈述时应谨慎行事,因为前瞻性陈述受到各种风险、不确定性和其他因素的影响,这些因素可能导致实际业绩与任何此类前瞻性陈述中表达的业绩存在重大差异。这些因素包括但不限于:公司在时间表内按照其预计的里程碑推进包括神经病学资产在内的候选产品的开发的能力;公司为开发候选产品筹集资金和获得非稀释性或其他资金的能力;监管申请流程、研发阶段以及与候选产品相关的未来临床数据和分析,包括任何会议、决策监管机构,例如FDA和研究审查委员会,无论是有利还是不利;公司获得、维持和执行必要专利和其他知识产权保护的能力;与脑震荡治疗相关的竞争和发展的性质;公司对临床前研究和临床试验结果的期望以及候选产品的潜在好处、活性、有效性和安全性,包括管理、传输、制造、储存和分销;以及总体经济和市场条件和风险,以及我们向美国证券交易委员会提交的文件中描述的其他不确定性。除非另有说明,否则所有信息均截至本文发布之日。在评估所包含的前瞻性陈述时,您应考虑这些因素,不要过分依赖此类陈述。除非法律另有规定,否则如果情况发生变化,我们不承担任何义务公开对任何前瞻性陈述进行修订或更新,无论是由于新信息、未来发展还是其他原因。

Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com

Oragenics, Inc.
珍妮特·霍夫曼,首席财务官
813-286-7900
jhuffman@oragenics.com

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Source: Oragenics

资料来源:Oragenics

Released May 22, 2024

2024 年 5 月 22 日发布

译文内容由第三方软件翻译。


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