Nova Mentis Enters Into Research Contract With KGK Science for Phase II A Clinical Trial
Nova Mentis Enters Into Research Contract With KGK Science for Phase II A Clinical Trial
Vancouver, British Columbia--(Newsfile Corp. - November 17, 2022) - Nova Mentis Life Science Corp. (CSE: NOVA) (OTCQB: NMLSF) (FSE: HN3Q) ("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 that it has entered into a research services agreement with KGK Sciences Inc. (KGK), a wholly owned subsidiary of Wellness Digital Science Inc., to conduct a planned Phase II A clinical trial to test the efficacy of psilocybin on patients diagnosed with fragile X syndrome (FXS).
温哥華，不列顛哥倫比亞省-(Newsfile Corp.-2022年11月17日)-Nova Mentis生命科學公司(CSE：NOVA)(OTCQB：NMLSF)(FSE：HN3Q)(“Nova”或“公司”)，亞洲網加利福尼亞州聖何塞10月23日電一家生物技術公司和神經炎性疾病的一流基於裸蓋菇素的療法和補充診斷方面的全球領先企業高興地宣佈，它已經與健康數字科學公司的全資子公司KGK Sciences Inc.(KGK)達成了一項研究服務協議，以進行計劃中的第二階段A臨牀試驗，以測試裸蓋菇素對被診斷為脆性X綜合徵(FXS)的患者的療效。
"NOVA's planned psilocybin treatment of FXS is a major drug development milestone for our company," said William Rascan, President & CEO of Nova Mentis. "We are confident that KGK's extensive experience in high-quality clinical research trials and expert regulatory support in the space will enable us to make considerable progress towards successful treatment of ASD and FXS, currently unmet medical needs."
Nova Mentis首席執行官總裁説：“Nova計劃用裸蓋菇素治療FXS對我們公司來説是一個重要的藥物開發里程碑。”我們相信，KGK在高質量臨牀研究試驗方面的豐富經驗和該領域的專家監管支持將使我們在成功治療ASD和FXS方面取得相當大的進展，這兩種疾病目前尚未得到滿足。“
"We are thrilled to be working with Nova Mentis for their planned phase II A clinical trials to test the efficacy of psilocybin-based therapeutics for the treatment of behavioural and cognitive symptoms associated with FXS. Over the past 25 years, we have successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies that move products efficiently into the global markets," commented Najla Guthrie, CEO of KGK.
KGK首席執行官納吉拉·格思裏評論説：“我們很高興能與Nova Mentis合作，進行他們計劃的第二階段A期臨牀試驗，以測試基於裸蓋菇素的療法對與FXS相關的行為和認知症狀的療效。在過去的25年裏，我們成功地幫助了數百家公司進行定製設計的臨牀試驗，並聲稱證實戰略，將產品有效地推向全球市場。”
The pioneering Phase II A clinical trial is the first human research investigating the potential of a microdose of psilocybin to improve behavioural and cognitive symptoms associated with FXS. The results of the 10-person, open-label study will be used to support NOVA's drug development program under FDA Orphan Drug designation, which was received in late 2021. Under the research and services agreement with NOVA, KGK will perform research services, including the development of the clinical trial protocol, regulatory and ethics submissions, conduct of the trial, data management and validation, statistical analysis and drafting of the final report ("Services"). The clinical trial is planned to be conducted at KGK's dedicated research facility in London, Ontario, Canada.
開創性的II階段A臨牀試驗是第一項人類研究，調查了微劑量裸蓋菇素改善與FXS相關的行為和認知症狀的可能性。這項10人的開放標籤研究的結果將用於支持Nova在FDA孤兒藥物指定下的藥物開發計劃，該計劃於2021年底收到。根據與Nova的研究和服務協議，KGK將提供研究服務，包括制定臨牀試驗方案、提交監管和倫理報告、進行試驗、數據管理和驗證、統計分析和起草最終報告(“服務”)。臨牀試驗計劃在KGK位於加拿大安大略省倫敦市的專門研究機構進行。
Additional Information Regarding the Agreement
有關該協議的其他信息
Pursuant to the Research Services Agreement, KGK shall provide Clinical Research Organization services, including a custom designed clinical trial protocol to oversee the Company's planned Health Canada Phase II A Clinical Trial in consideration of the Company issuing units of the Company (the "Units") upon certain performance milestones being met, in the aggregate amount of up to $488,951.
根據研究服務協議，KGK將提供臨牀研究組織服務，包括定製設計的臨牀試驗方案，以監督公司計劃的Health Canada II A期臨牀試驗，並考慮到公司在達到某些業績里程碑時發放公司的單位(“單位”)，總金額高達488,951美元。
Each Unit shall consist of one common share in the capital of the Company ("Shares") and one-half of one warrant to purchase common shares in the capital of the Company ("Warrants"). The Units shall be issued at a deemed price equal to the greater of (a) $0.05 and (b) the closing market price of the Company's Shares on the Canadian Securities Exchange ("CSE") less the maximum allowable discount under the policies of the CSE, at the time of issuance. The Warrants shall be valid for a term of two (2) years from issuance and each whole warrant shall be exercisable at a price equal to the greater of (a) $0.075 and (b) the closing market price of the Company's Shares on the CSE, at the time of issuance. The Units shall be subject to a four month and one day hold period commencing on the day of issuance.
每個單位應包括一股本公司股本中的普通股(“股份”)和一份購買本公司股本中普通股的認股權證(“認股權證”)的一半。該等單位的發行價應視為等於(A)0.05美元及(B)本公司股份於發行時在加拿大證券交易所(“CSE”)的收市價減去CSE政策所容許的最大折讓金額兩者中較大者。該等認股權證的有效期為自發行起計兩(2)年，每份整份認股權證可按相當於(A)0.075美元及(B)本公司股份於發行時在聯交所的收市價中較大者的價格行使。這些單位自發行之日起有四個月零一天的持有期。
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 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那些沒有滿足醫療需求的令人衰弱的慢性疾病，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。
About KGK Science
關於KGK Science
Subsidiary of Wellbeing Digital Sciences, KGK 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.
KGK是WellBeing Digital Sciences的子公司，是一家總部設在安大略省倫敦市的北美領先的合同研究機構，主要提供高質量的臨牀研究試驗，重點是營養食品和新興保健產品。該公司成立於1997年，已成功幫助數百家公司進行了定製設計的臨牀試驗和聲稱的證實戰略，以將產品推向全球市場。KGK的其他現有服務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，該公司已經出版了150多份出版物，執行了40多個適應症的400多項臨牀試驗，在其數據庫中積累了2.5萬名參與者，並收集了1000萬個數據點。
For more information, please visit: .
如需更多信息，請訪問：.
About Wellbeing Digital Sciences
關於Welling數字科學
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development.
幸福數字科學公司是一家以循證為基礎的精神保健公司，專注於開發和實施創新的臨牀治療解決方案，包括迷幻藥物和數字療法，並得到臨牀研究的支持。它的使命得到了北美診所網絡的支持，這些診所向患者提供前瞻性治療和其他類型的治療，以及通過一個合同研究組織向尋求藥物開發的客户提供臨牀試驗服務。
For additional information, please visit:
欲瞭解更多信息，請訪問：
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。
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。