Entheon Biomedical Announces the Approval of DMT Clinical Trial
Entheon Biomedical Announces the Approval of DMT Clinical Trial
Vancouver, British Columbia--(Newsfile Corp. - February 3, 2022) - Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) ("Entheon" or the "Company"), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, announced today the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT). The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.
温哥華，不列顛哥倫比亞省-(Newsfile Corp.-2022年2月3日)-Entheon Biomedical Corp.(CSE：ENBI)(OTCQB：ENTBF)(FSE：1XU1)(“恩瑟恩“或”公司“)，一家專注於研究和開發迷幻藥物和尖端生物標記物，為成癮障礙提供個性化治療的生物醫藥公司，今天宣佈荷蘭當地倫理委員會批准EBRX-101，這是一項全面的I期臨牀試驗，評估N，N-二甲基色胺(DMT)的藥代動力學、藥效學和安全性。這項研究將在荷蘭萊頓的人類藥物研究中心進行，患者篩查定於本月開始。
The EBRX-101 study is the core research focus of Entheon Rx™, one of the Company's business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues. The study will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers. This phase 1 study will provide Entheon with essential safety and dosing data, providing the foundation for further research of DMT's therapeutic potential.
EBRX-101研究是該公司的業務部門之一Entheon Rx™的核心研究重點，該部門主要致力於提高藥物治療和基於藥物治療的類似物的治療潛力。這項研究將採用適應性、隨機化、雙盲、安慰劑對照設計，通過持續控制輸液給一組其他健康的吸煙者靜脈注射單次遞增劑量的DMT。這項第一階段研究將為Entheon提供必要的安全性和劑量數據，為進一步研究DMT的治療潛力奠定基礎。
"DMT's unique metabolic and neuroprotective properties, together with its record of safe human use in the scientific literature, suggests that it is an ideal candidate for therapeutic administration," says Dr. Andrew Hegle, Chief Science Officer of Entheon. "However, it is crucial that we thoroughly investigate the pharmacological properties and safety profile of infused DMT in a clinical setting, and fully characterize its effects on the central nervous system. These results will form the basis for Entheon's phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders."
Entheon公司首席科學官安德魯·黑格爾博士説：“DMT獨特的新陳代謝和神經保護特性，再加上它在科學文獻中對人類安全使用的記錄，表明它是治療用藥的理想候選者。”然而，至關重要的是，我們必須在臨牀環境中徹底調查注射的DMT的藥理特性和安全性，並充分描述其對中樞神經系統的影響。這些結果將成為Entheon公司戒煙和治療其他物質使用障礙的第二階段療效試驗的基礎。“
DMT is a classic hallucinogen, similar to LSD or psilocybin in that it exerts many of its subjective, visual, and potentially therapeutic effects via the brain's serotonin system. DMT differs from the other serotonergic psychedelics in that it is naturally found in the body in trace amounts, and when given externally is rapidly metabolized, with subjective effects returning to baseline after roughly thirty minutes post- administration.
DMT是一種經典的迷幻劑，類似於LSD或裸蓋菇素，它通過大腦的5-羥色胺系統發揮許多主觀、視覺和潛在的治療效果。DMT與其他5-羥色胺能迷幻藥的不同之處在於，它在體內以微量的形式自然存在，當外部給藥時，它會迅速代謝，主觀效果在給藥後大約30分鐘後恢復到基線水平。
"Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work," says Timothy Ko, CEO of Entheon. "In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive studies of DMT to date. This clinical trial will serve as a benchmark for further investigation into the development of DMT as a treatment for addiction disorders."
Entheon的首席執行官Timothy Ko説：“這項研究的批准對公司來説是一項重大的成就，標誌着幾個月的嚴謹工作達到了頂峯。”根據我們的估計和對現有文獻的回顧，EBRX-101是迄今為止對DMT進行的最全面的研究。這項臨牀試驗將成為進一步調查DMT作為治療成癮障礙的發展的基準。“
About Entheon Biomedical Corp.
Entheon Biomedical Corp.簡介
Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N, N-dimethyltryptamine (DMT) as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.
Entheon是一家生物醫藥公司，專注於迷幻藥物和前沿生物標記物的研究和開發，為成癮障礙提供個性化治療。Entheon由三個部門組成，Entheon RX™，專注於治療藥物的開發，使用N，N-二甲基色胺(T.N：行情)DMT作為藥理學基準的Entheon ID™；Entheon ID™，側重於腦電生物標誌物和遺傳學在藥物治療選擇和管理中的識別、分析和預測性使用；以及Entheon IQ™，側重於通過分析患者數據開發治療算法。在獲得所有必要的監管批准和許可後，Entheon公司打算通過向美國、歐盟某些國家和加拿大各地的醫生、診所和有執照的精神病學家銷售其DMT產品來創造收入。
For more information, please contact the Company at:
如需更多信息，請聯繫本公司，網址為：
Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
Entheon Biomedical Corp.
約瑟夫·庫倫(Joseph Cullen)，投資者關係部
電話：+1(778)919-8615
郵箱：Joe@entheonbibiedical.com
For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:
如有媒體查詢，請聯繫藍天通信公司的伊麗莎白·格拉森(Elizabeth Glassen)，電話：
BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
eglassen@blueskycommunications.com
藍天通信
客户經理Elizabeth Glassen
電話：+1(647)309-0141
郵箱：eglassen@BlueskyCommunications.com
Cautionary Note on Forward-Looking Information
關於前瞻性信息的警示説明
This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the timing and the commencement of EBRX-101 site initiation; the timing and initial screening, successful patient recruitment and enrollment; whether the results of the study will provide adequate data; whether the results of the phase 1 trial will be sufficient for a phase 2 trial and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company, including, but not limited to, assumptions relating to the continued impact and status of COVID on the Company's personnel and planned research activities, that general economic and political conditions will remain the same, stability in applicable law and regulations and that future studies will occur. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.
本新聞稿包含符合適用證券法的前瞻性陳述和前瞻性信息。這些陳述與未來事件或未來表現有關。除歷史事實以外的所有陳述都可能是前瞻性陳述或信息。更具體地説，本新聞稿包括但不限於前瞻性陳述和信息，涉及EBRX-101試驗啟動的時間和開始；EBRX-101試驗啟動的時間和初始篩選；成功的患者招募和登記；研究結果是否能提供足夠的數據；第一階段試驗的結果是否足以進行第二階段試驗以及其他事項。前瞻性陳述和信息基於公司管理層做出的某些重要預期和假設，包括但不限於有關COVID對公司人員和計劃中的研究活動的持續影響和地位、總體經濟和政治條件將保持不變、適用法律法規保持穩定以及未來將進行研究的假設。儘管公司管理層認為這些前瞻性陳述和信息所基於的預期和假設是合理的，但不應過度依賴前瞻性陳述和信息，因為不能保證它們將被證明是正確的。
Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.
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Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
CSE和加拿大投資行業監管組織均不對本新聞稿的充分性或準確性承擔責任。
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