Nova Submits Phase II A Psilocybin Clinical Trial Application to Health Canada
Nova Submits Phase II A Psilocybin Clinical Trial Application to Health Canada
Microdose Psilocybin Safety and Efficacy Clinical Study in Fragile X Syndrome
微劑量裸蓋菇素治療脆性X綜合徵的安全性和有效性臨牀研究
Vancouver, British Columbia--(Newsfile Corp. - November 30, 2022) - 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 proud to announce that the company has submitted to Health Canada the first-ever Phase II A clinical trial application (CTA) testing the safety and efficacy of oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD).
温哥華，不列顛哥倫比亞省-(Newsfile Corp.-2022年11月30日)-Nova Mentis生命科學公司(CSE：NOVA)(FSE：HN3Q)(OTCQB：NMLSF)(“Nova”或“公司”)，一家生物技術公司和一流的基於裸蓋菇素的神經炎性疾病治療和補充診斷領域的全球領先企業自豪地宣佈，該公司已向加拿大衞生部提交了有史以來第一份第二階段A臨牀試驗申請(CTA)，測試口服微劑量裸蓋菇素治療脆性X綜合徵(FXS)的安全性和有效性。FXS是導致自閉症譜系障礙(ASD)的主要遺傳原因。
"NOVA's clinical trial application is a major step in the commercial development of the Company's proprietary psilocybin drug," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "NOVA's drug development plan is to initially establish the therapeutic potential of repetitive low-dose psilocybin to adults with FXS to improve behavioural and cognitive symptoms."
Nova公司科學顧問委員會主席Marvin S.Hausman博士説：“Nova公司的臨牀試驗應用是公司專有裸蓋菇素藥物商業開發的重要一步。Nova的藥物開發計劃是初步確定重複小劑量裸蓋菇素對患有FXS的成年人的治療潛力，以改善行為和認知症狀。“
The CTA is subject to a 30-day review by Health Canada, and if approval is granted, NOVA intends to start the clinical study in early 2023. This open-label 10 patient study will also be used to support the Company's drug development program under U.S. FDA Orphan Drug designation, which was received in late 2021.
CTA需要接受加拿大衞生部為期30天的審查，如果獲得批准，Nova打算在2023年初開始臨牀研究。這項開放標籤的10名患者研究還將用於支持該公司在美國FDA孤兒藥物指定下的藥物開發計劃，該計劃於2021年底獲得。
NOVA has completed the production of its pharmaceutical grade, cGMP synthetic psilocybin 1.5 mg microdose capsules that will be used to advance the necessary research and development steps required for successful drug regulatory approval and future commercialization.
Nova公司已經完成了其製藥級cGMP合成裸蓋菇素1.5 mg微劑量膠囊的生產，這種膠囊將用於推進成功獲得藥品監管部門批准和未來商業化所需的必要研究和開發步驟。
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生命科學公司是一家總部位於加拿大的生物技術公司，在開發神經炎性疾病的診斷和基於裸蓋菇素的療法方面處於全球領先地位。Nova是第一家在美國和歐盟獲得使用裸蓋菇素治療脆性X綜合徵(FXS)的孤兒藥物指定的生物技術公司。
Our goal is to diagnose and treat debilitating chronic neuroinflammatory conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.
我們的目標是診斷和治療尚未滿足醫療需求的衰弱的慢性神經炎性疾病，如自閉症譜系障礙(ASD)和FXS。
For further information on the Company, please visit or email info@novamentis.ca.
欲瞭解更多有關公司的信息，請訪問或發送電子郵件至info@novamentis.ca。
On Behalf of the Board
我謹代表董事會
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
威爾·拉斯坎，總裁兼首席執行官
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。此類前瞻性表述涉及已知和未知的風險、不確定性和其他因素，可能導致Nova Mentis生命科學公司的實際結果、業績或成就或行業發展與此類前瞻性表述明示或暗示的預期結果、業績或成就大不相同。前瞻性陳述是指不是歷史事實的陳述，通常但並非總是由“預期”、“計劃”、“預期”、“相信”、“打算”、“估計”、“項目”、“潛在”和類似的表述，或事件或條件“將”、“將”、“可能”、“可能”或“應該”發生。
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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。