Nova Mentis Provides Corporate Update and 2023 Outlook
Nova Mentis Provides Corporate Update and 2023 Outlook
Vancouver, British Columbia--(Newsfile Corp. - April 5, 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 provide a corporate update, including planned catalysts for 2023.
溫哥華，不列顛哥倫比亞省-(Newsfile Corp.-2023年4月5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，在一流的基於裸蓋菇素的療法和神經炎性疾病的補充診斷方面處於全球領先地位，很高興提供公司的最新情況，包括計劃在2023年使用的催化劑。
"NOVA executed on several key research and drug development milestones in 2022, which has set the stage for a meaningful 2023. Our focus remains on advancing our proprietary psilocybin drug (NM-1001) and conducting the first-ever human trial evaluating the safety and efficacy of oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD)," says William Rascan, NOVA's President & CEO.
Nova總裁兼首席執行官威廉·拉斯坎表示：“Nova在2022年執行了幾項關鍵的研究和藥物開發里程碑，這為有意義的2023年奠定了基礎。我們的重點仍然是推進我們的專有裸蓋菇素藥物(NM-1001)，並進行有史以來第一次人體試驗，評估口服微劑量裸蓋菇素治療脆性X綜合徵的安全性和有效性。脆性X綜合徵是自閉症譜系障礙的主要遺傳原因。”
"We look forward to a busy 2023 as we continue in our efforts to deliver new and life-changing therapies for those with autism, the fastest growing developmental disability in the world. We believe psilocybin has the potential to offer new hope to patients who are searching for safe and effective treatment solutions to help with the behavioural and cognitive symptoms associated with autism," says Dr. Marvin S. Hausman, the Chairman of NOVA's Scientific Advisory Board.
Nova科學諮詢委員會主席馬文·S·豪斯曼博士說：“我們期待著2023年的忙碌，因為我們繼續努力為自閉症患者提供新的、改變生活的療法。自閉症是世界上增長最快的發展性殘疾。我們相信裸蓋菇素有潛力為那些正在尋找安全有效的治療方案來幫助緩解與自閉症相關的行為和認知癥狀的患者帶來新的希望。”
"I joined the NOVA team this year because I see the incredible potential of this new area of medicine and was impressed with the accomplishments NOVA achieved in such a short amount of time. From promising preclinical data and securing Orphan Drug status, to producing a large supply of synthetic psilocybin and earning Health Canada approval for a human study - the level of promise ahead of us is very exciting," says Derek Ivany, NOVA's Executive Chairman.
Nova執行主席德里克·伊萬尼說：“我今年加入Nova團隊，是因為我看到了這一新醫學領域令人難以置信的潛力，並對Nova在如此短的時間內取得的成就印象深刻。從承諾臨床前數據和獲得孤兒藥物地位，到生產大量合成裸蓋菇素並獲得加拿大衛生部批准進行人體試驗--我們面前的承諾水準非常令人興奮。”
The Nova 2022 Story: Accomplishments
新星2022的故事：成就
Formed a tactical partnership with KGK Science Inc. to develop NOVA's psychedelic psilocybin drug portfolio in Canada and jointly submit a psilocybin clinical trial application to Health Canada.
Successfully completed an oral microdose psilocybin preclinical study in the laboratory of Dr. Viviana Trezza at Rome Tre University in Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company's proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS.
Begun the patient enrollment process and enrolled 100+ participants into NOVA's North American Observational study: Establishing a Diagnostic and Therapeutic Index in ASD and FXS.
Partnered with the Toronto Institute of Pharmaceutical Technology (TIPT) to complete production of a large supply of >98% pure psilocybin capsules for clinical studies and commercialization following drug approval.
Received the necessary permits from Health Canada and the U.S. Drug Enforcement Administration (DEA) to ship the Company's proprietary psilocybin drug (NM-1001) from its manufacturing partner to the labs at TIPT.
Signed a research agreement with the University of Central Florida (UCF) Research Foundation to develop a saliva serotonin assay that will measure serotonin levels in the saliva samples collected as part of NOVA's autism observational study.
Bolstered its IP with the filing of provisional patent applications to protect data it obtained during its psilocybin preclinical studies and provide protection for the Company's therapeutic paradigm for treating neuroinflammatory disorders with psilocybin and psilocybin-based tryptamine derivatives.
Submitted to Health Canada the first-ever Phase IIA clinical trial application testing the safety and efficacy of oral microdose psilocybin therapy for FXS.
NOVA's psilocybin preclinical study results were published in Psychopharmacology, a fully peer-reviewed, international science journal.
Received Health Canada approval for first-of-its-kind psilocybin ASD clinical trial. The human study will evaluate the Company's proprietary psilocybin drug (NM-1001) in the treatment of FXS.
與KGK Science Inc.建立了戰術合作夥伴關係，以開發Nova在加拿大的迷幻裸蓋菇素藥物組合，併聯合向加拿大衛生部提交裸蓋菇素臨床試驗申請。
在意大利羅馬大學Viviana Trezza博士的實驗室裡，成功完成了口服微劑量裸蓋菇素的臨床前研究。結果超出了所有人的預期，發現非常低劑量的該公司專利裸蓋菇素藥物(NM-1001)顯著調節了FXS遺傳模型中的行為和認知缺陷，如識別記憶。
開始了患者登記過程，並招募了100多名參與者參加Nova的北美觀察性研究：建立ASD和FXS的診斷和治療指標。
與多倫多製藥技術研究所(TIPT)合作，完成了大量供應>98%純裸蓋菇素膠囊的生產，用於臨床研究和藥物批准後的商業化。
獲得加拿大衛生部和美國禁毒署(DEA)的必要許可，將該公司的裸蓋菇素專利藥物(NM-1001)從其製造合作夥伴運往TIPT的實驗室。
與中佛羅裡達大學(UCF)研究基金會簽署了一項研究協定，開發一種唾液5-羥色胺檢測方法，該方法將測量作為Nova自閉症觀察研究一部分收集的唾液樣本中的5-羥色胺水準。
通過提交臨時專利申請支持其知識產權，以保護其在裸蓋菇素臨床前研究期間獲得的數據，並為公司使用裸蓋菇素和基於裸蓋菇素的色胺衍生物治療神經炎性疾病的治療範例提供保護。
向加拿大衛生部提交了有史以來第一個IIA期臨床試驗申請，測試口服微劑量裸蓋菇素治療FXS的安全性和有效性。
Nova的裸蓋菇素臨床前研究結果發表在《精神藥理學》上，這是一本完全由同行評審的國際科學雜誌。
獲得加拿大衛生部批准，進行首個裸蓋菇素ASD臨床試驗。這項人體研究將評估該公司治療FXS的裸蓋菇素專利藥物(NM-1001)。
Anticipated 2023 Milestones:
預計2023年的里程碑：
2023 kicked off with promising developments, as NOVA received an exemption under Section 56 of Canada's Controlled Drugs and Substances Act allowing the Company to proceed with the first-ever Phase IIA clinical trial assessing repetitive, oral microdose psilocybin therapy for adults with fragile X.
2023年以良好的進展拉開序幕，Nova根據加拿大《受控藥物和物質法案》第56條獲得豁免，允許該公司繼續進行有史以來第一個IIA期臨床試驗，評估針對患有脆性X的成年人的重複口服微劑量裸蓋菇素療法。
Other planned catalysts for 2023 include:
2023年計劃的其他催化劑包括：
Recruiting participants for NOVA's Health Canada approved psilocybin study in fragile X syndrome.
Evaluating potential corporate partners with interest in NOVA's psilocybin drug portfolio and clinical research supplies.
Nova‘s Health Canada的招募參與者批准了裸蓋菇素在脆性X綜合徵中的研究。
評估對Nova的裸蓋菇素藥物組合和臨床研究用品感興趣的潛在企業合作夥伴。
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 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FXS的孤兒藥物指定的生物技術公司。
NOVA's goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as ASD and FXS.
Nova的目標是診斷和治療尚未滿足醫療需求的慢性疾病，如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資訊，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”、“專案”、“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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譯文內容由第三人軟體翻譯。