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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 任命醫學博士 William “Frank” Peacock 爲首席臨床官
Oragenics ·  05/22 12:00

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

Oragenics任命William“Frank”Peacock博士爲首席臨床官

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

Peacock博士將監督急診科治療腦震盪的即將到來的II期臨床試驗

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.

佛羅里達州薩拉索塔,May 22, 2024 (環球新聞通訊社)--Oragenics, Inc.(紐交所美國股票代碼:OGEN)是一家專注於開發治療神經疾病的獨特鼻腔藥物的公司。今天宣佈任命William“Frank”Peacock博士爲首席臨床官,他將開展該公司期望的用於應急科治療腦震盪的II期臨床試驗。Oragenics的領頭藥物候選ONP-002與其鼻內置入裝置結合使用,旨在治療顱腦外傷輕度損傷,常稱爲腦震盪,該裝置將在現場和急診科使用。ONP-002是一種新的化學實體(NCE),旨在通過將其輸送到鼻腔並向大腦輸送來靶向大腦。一項40個患者的一期研究已經完成,並顯示出該藥物是安全且耐受的。

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".

Peacock博士目前擔任貝勒醫學院緊急醫學研究副主席,曾在克利夫蘭診所勒納醫學院擔任教授。他還是一家公司開展的用於在急診室中確定腦震盪的血液生物標誌物試驗的主要研究員,該試驗分析了腦震盪後升高的急性血液標誌物,不僅要確保腦震盪得到識別,還要作爲潛在程度和長期併發症的預測因素。Peacock博士是一位享譽世界的演講家和研究員。他在獲得急性冠狀動脈綜合症失敗高靈敏度血清心肌肌鈣蛋白批准和使用上起着關鍵作用,這可以在《美國醫學會》的《心臟病學》出版物中看到,即“高靈敏度肌鈣蛋白T在鑑別可能患有急性冠狀動脈綜合症的最低風險患者中的有效性”,他還是“創傷性腦損傷生物標誌物”第一本書的編輯。JAMA《心臟病學》出版物高靈敏度肌鈣蛋白T在鑑別可能患有急性冠狀動脈綜合症的最低風險患者中的有效性他是“創傷性腦損傷生物標誌物”第一本書的編輯。

"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.

Peacock博士表示:“我很高興在Oragenics擔任首席臨床官,因爲這是該公司臨床項目非常重要和關鍵的時刻。我的30多年職業生涯中一直從事急診室的腦震盪護理。我的HeadSMART血液生物標誌物試驗一角向我展示了我們需要生物標誌物在急診室觸發治療。我們正在尋找這種治療方法,我期待測試ONP-002,幫助判斷它是否可以改善我們即將進行的II期臨床試驗中患者的預後。”

"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.

Oragenics總裁Michael Redmond表示:“我們很幸運地讓這位享有盛譽的急診醫學專家和研究人員擔任這個重要角色加入我們的團隊。鑑於他對血生物標誌物的了解,他在整個職業生涯中對急診醫學流程的熟悉和與TBI臨床研究的領先招募中心緊密聯繫,我們相信他將在Oragenics和計劃的II期臨床試驗的成功中發揮不可估量的作用。我們目前正在與CRO Avance Clinical合作進行II期臨床試驗。”

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.

在動物的臨床前模型中,ONP-002已被證明可以在腦損傷後快速改善分子和行爲結果。此外,將藥物作爲納米顆粒通過鼻內遞送已被證明可以增強動物的大腦暴露和代謝。Peacock博士表示:“我們的I期人類研究已經表明ONP-002在人類中耐受性良好。II期試驗的設計旨在確定第一劑的時間,藥物應用和血液生物標誌物水平之間的關係,並在受傷後的最初幾個小時和幾天內評估患者症狀的嚴重程度。”

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.

腦震盪是醫療領域的一大需求。全球報告的腦震盪數量約爲6900萬例。導致腦震盪的常見原因包括跌倒、機動車事故和接觸性運動。其他神經疾病,包括阿爾茨海默病、帕金森氏病和慢性創傷性腦病(CTE),都與腦震盪有關。腦震盪後綜合症與長期殘疾有關,並且在腦震盪患者中高達20%。

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.

關於Oragenics
Oragenics是一家發展階段的生物技術公司,專注於神經系統藥物的鼻腔給藥和對抗傳染病,包括用於治療輕度創傷性腦損傷(mTBI)、也稱爲腦震盪,以及用於治療尼曼·匹克病C型(NPC)的藥物候選品,以及專有粉末製劑和鼻腔遞送裝置。欲獲取更多信息,請訪問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.

前瞻性聲明
本通訊包含《美國私人證券訴訟改革法》中的適用的“前瞻性聲明”,包括但不限於有關公司能夠及時併成功進行Phase II臨床試驗使用其新藥物-器械組合治療輕度創傷性腦損傷的能力的聲明。這些前瞻性聲明基於管理層的信念、假設和當前可用信息。不僅與歷史事實有關的“相信”、“預期”、“預測”、“打算”、“估計”、“計劃”和類似表述詞,識別前瞻性聲明,投資者應在依靠前瞻性聲明時保持謹慎,因爲它們受到各種風險、不確定性和其他因素的影響,這些因素可能導致實際結果與任何此類前瞻性聲明中表達的結果在很大程度上不同。這些因素包括但不限於:公司能否在其所預計的時間表下並按照其所預期的里程碑推進其產品候選品,包括神經科學資產的發展;公司能否籌集資本並獲得用於開發其產品候選品的融資,無論是否爲非稀釋性;與其產品候選品有關的監管申請過程、研發階段和未來臨床數據和分析,包括任何會議、決策、如美國食品和藥物管理局和調查評審委員會之類的監管當局是否有利或不利;公司能否獲得、維護和執行必需的專利和其他知識產權保護;與腦震盪治療有關的競爭和發展;公司對臨床前和臨床試驗以及其產品候選品的其他經濟和市場條件和風險的預期以及其活動、效力和安全性;以及一般經濟和市場狀況和風險,以及其他在我們向美國證券交易委員會提交的文件中描述的不確定性。除非另有說明,這裏的所有信息均截至本日期。您應在評估所包含的前瞻性聲明時考慮這些因素,並不應對這些聲明提供任何修訂或更新,無論是因爲新信息、未來發展還是其他原因的變化,除非法律另有規定。

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

Oragenics, Inc.
Janet Huffman,首席財務官
813-286-7900
jhuffman@oragenics.com

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Source: Oragenics

來源:oragenics

Released May 22, 2024

發佈於2024年5月22日

譯文內容由第三人軟體翻譯。


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