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Nova Mentis Receives Institutional Review Board Approval to Commence Psilocybin Clinical Trial

Nova Mentis Receives Institutional Review Board Approval to Commence Psilocybin Clinical Trial

Nova Mentis 獲得機構審查委員會批准開始psilocybin臨牀試驗
newsfile ·  2023/04/11 20:30

Vancouver, British Columbia--(Newsfile Corp. - April 11, 2023) - Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) ("NOVA" or the "Company"), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce it has received institutional review board (IRB) approval in Canada to begin its human study testing the efficacy of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).

不列顛哥倫比亞省溫哥華--(Newsfile Corp.-2023 年 4 月 11 日)- Nova Mentis Life Science Corp.(CSE:NOVA)(FSE:HN3Q)(OTCQB:NMLSF)(“NOVA” 或 “公司”), 一家生物技術公司和神經炎症性疾病同類首創的基於裸蓋細胞素的療法和輔助診斷領域的全球領導者欣然宣佈,它已獲得加拿大機構審查委員會(IRB)的批准,開始進行人體研究,測試psilocybin對被診斷患有脆性X綜合徵(FXS)的成年人的療效,脆性X綜合徵是自閉症譜系障礙(ASD)的主要遺傳病因。

The Phase IIA clinical trial received the go-ahead from Health Canada in December of 2022 and is one of the first approved studies that will permit participants to take home the drug for dosing every other day. The Company plans to begin the recruitment process within the coming weeks.

IIA 期臨牀試驗於 2022 年 12 月獲得加拿大衛生部的批准,是首批批准的允許參與者每隔一天將藥物帶回家給藥的研究之一。該公司計劃在未來幾周內開始招聘流程。

"Our team has been methodically achieving the necessary approvals and clinical planning to initiate this important study that supports NOVA's mission to improve the quality of life for people with autism and fragile X," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "This approval further validates our high standards of ethical and clinical practice and is a significant clinical milestone for this study."

NOVA科學顧問委員會主席Marvin S. Hausman博士表示:“我們的團隊一直在有條不紊地獲得必要的批准和臨牀規劃,以啓動這項重要的研究,以支持NOVA改善自閉症和脆弱X患者生活質量的使命。”“該批准進一步證實了我們的高倫理和臨牀實踐標準,是這項研究的重要臨牀里程碑。”

IRBs are ethics committees designed to help regulatory agencies ensure that companies employ rigorous protocol standards and adhere to strict regulations surrounding the ethical treatment of human subjects.

IRB 是道德委員會,旨在幫助監管機構確保公司採用嚴格的協議標準並遵守有關人類受試者道德待遇的嚴格規定。

KGK Science and NOVA have partnered to conduct the first-ever clinical trial to investigate the effects of psilocybin on the cognitive and behavioural symptoms associated with FXS. The results of the 10-person, open-label study will assess repetitive, oral microdose psilocybin therapy for FXS. The Company intends to validate behavioural testing with state-of-the-art diagnostic and therapeutic biomarker technology, and machine learning artificial intelligence (AI).

KGK Science和NOVA合作進行了有史以來的首次臨牀試驗,以研究psilocybin對與FXS相關的認知和行爲症狀的影響。這項由10人組成的開放標籤研究的結果將評估FXS的重複口服微劑量psilocybin療法。該公司打算使用最先進的診斷和治療生物標誌物技術以及機器學習人工智能(AI)來驗證行爲測試。

NOVA's preclinical research results, which were published in an international science journal, showed that a low microdose formulation of the Company's psilocybin drug significantly modulated behavioural and cognitive defects in a genetic model of FXS.

NOVA的臨牀前研究結果發表在一家國際科學期刊上,結果表明,該公司psilocybin藥物的低劑量配方可顯著調節FXS遺傳模型中的行爲和認知缺陷。

About Nova Mentis Life Science Corp.

關於 Nova Mentis 生命科學公司

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of fragile X syndrome (FXS).

Nova Mentis Life Science Corp. 是一家總部位於加拿大的生物技術公司,也是開發神經炎症性疾病診斷和基於psilocybin的療法的全球領導者。Nova是第一家在美國和歐盟因使用psilocybin治療脆性X綜合徵(FXS)而獲得孤兒藥稱號的生物技術公司。

NOVA's goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

NOVA的目標是診斷和治療醫療需求未得到滿足的使人衰弱的慢性病,例如自閉症譜系障礙(ASD)和FXS。

For further information on the Company, please visit or email info@novamentis.ca.

有關公司的更多信息,請訪問或發送電子郵件至 info@novamentis.ca。

About KGK Science

關於 KGK Science

A subsidiary of Wellbeing Digital Sciences, KGK Science is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK's other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database, and collected 10 million data points. For additional information, please visit .

作爲Wellebing Digital Sciences的子公司,KGK Science是一家總部位於安大略省倫敦的領先的北美合同研究組織,主要提供高質量的臨牀研究試驗,重點是營養品和新興醫療保健產品。該公司成立於1997年,已成功幫助數百家公司進行定製設計的臨牀試驗和索賠證實策略,將產品推向全球市場。KGK的其他現有服務線包括專家監管支持和合規解決方案、參與者招聘、研究支持服務和諮詢服務。此外,該公司還出版了150多份出版物,針對40多個適應症進行了400多項臨牀試驗,在其數據庫中積累了25,000名參與者,並收集了1000萬個數據點。如需更多信息,請訪問。

On Behalf of the Board

代表董事會

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

總裁兼首席執行官威爾·拉斯坎
Nova Mentis 生命科學公司

Phone: 778-819-0244
Toll Free: 1-833-542-5323

電話:778-819-0244
免費電話:1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

推特:@novamentislsc
Instagram:@novamentislsc
臉書:@novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

加拿大證券交易所及其市場監管機構(該術語在加拿大證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

This news release contains statements that constitute "forward-looking statements." Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science's actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur.

本新聞稿包含構成 “前瞻性陳述” 的陳述。此類前瞻性陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致Nova Mentis Life Science的實際業績、業績或成就或該行業的發展與此類前瞻性陳述所表達或暗示的預期業績、業績或成就存在重大差異。前瞻性陳述不是歷史事實,通常但並非總是以 “期望”、“計劃”、“預期”、“相信”、“打算”、“估計”、“項目”、“潛力” 和類似表達方式來識別,或者事件或條件 “將”、“將”、“可能” 或 “應該” 發生。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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