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Nova Mentis Psilocybin Microdose Capsule Formulation to Be Submitted in Health Canada Phase 2A Clinical Trial Application

Nova Mentis Psilocybin Microdose Capsule Formulation to Be Submitted in Health Canada Phase 2A Clinical Trial Application

新曼蒂斯裸蓋菇素微劑量膠囊製劑將提交加拿大衞生部第2A期臨牀試驗申請
newsfile ·  2022/09/29 20:40

Vancouver, British Columbia--(Newsfile Corp. - September 29, 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 pleased to announce that the company has produced 1.5 mg psilocybin microdose capsules. These capsules were produced according to defined manufacturing processes and product specifications as outlined in chemistry, manufacturing and controls (CMC) published guidelines.

温哥華,不列顛哥倫比亞省-(Newsfile Corp.-2022年9月29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以裸蓋菇素為基礎的療法和神經炎性疾病輔助診斷的全球領先企業高興地宣佈,該公司已經生產了1.5毫克裸蓋菇素微劑量膠囊。這些膠囊是根據化學、製造和控制(CMC)發佈的指南中概述的定義的製造工藝和產品規格生產的。

"NOVA has accomplished a major breakthrough in its autism spectrum disorder (ASD) clinical research program with the production of GMP grade psilocybin microdose capsules," stated Jacqueline McConnell, NOVA's Chief Operating Officer. "NOVA is also excited to initiate the availability of the 1.5 mg psilocybin capsules to doctors, clinics and pharmaceutical companies in Canada for its potential therapeutic use in non-ASD clinical trials, including but not limited to diabetes, heart disease, epileptic conditions and post-traumatic stress disorder (PTSD). NOVA and KGK Science Inc. (KGK) are available to assist in the creation and submission of future clinical trial applications to Health Canada for review."

Nova公司首席運營官傑奎琳·麥康奈爾説:“Nova公司通過生產GMP級裸蓋菇素微劑量膠囊,在其自閉症譜系障礙(ASD)臨牀研究計劃方面取得了重大突破。Nova還很高興開始向加拿大的醫生、診所和製藥公司提供1.5毫克裸蓋菇素膠囊,用於非自閉症臨牀試驗的潛在治療用途,包括但不限於糖尿病、心臟病、癲癇和創傷後應激障礙(PTSD)。Nova和KGK Science Inc.(KGK)可以協助創建未來的臨牀試驗申請,並將其提交加拿大衞生部審查。

NOVA has in hand a complete CMC package to be used in support of a phase 2A microdose psilocybin fragile X syndrome (FXS) clinical trial application. The package to be submitted to Health Canada for review includes:

Nova公司手頭有一套完整的CMC包,用於支持2A期微劑量裸蓋菇素脆性X綜合徵(FXS)的臨牀試驗應用。將提交加拿大衞生部審查的一攬子計劃包括:

  • Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API).
  • Finished product batch manufacturing records that confirms final capsule batch has been produced.
  • Psilocybin capsule dissolution parameters that meet regulatory requirements.
  • 裸蓋菇素活性藥物成分(原料藥)第二階段製造工藝文件。
  • 確認最終膠囊批次已經生產的成品批次生產記錄。
  • 裸蓋菇素膠囊的溶出度參數符合法規要求。

NOVA and KGK, its clinical research organization (CRO) partner, are currently finalizing the clinical trial application that will be submitted to Health Canada for approval of a Phase 2A study evaluating psilocybin microdose therapy for FXS, the leading genetic cause of ASD.

Nova及其臨牀研究組織(CRO)合作伙伴KGK目前正在敲定臨牀試驗申請,該申請將提交給加拿大衞生部批准一項評估裸蓋菇素微劑量療法治療FXS的第2A階段研究。FXS是ASD的主要遺傳原因。

Further, the Company has granted an aggregate of 4,600,000 incentive stock options ("the Options") to members of its Board, management team and consultants of the Company. The Options are exercisable at a price $0.05 per share for a period of 5 years. The Options have been granted under and are governed by the terms of the Company's incentive stock option plan.

此外,本公司已向董事會成員、管理團隊及本公司顧問授予合共4,600,000份激勵性股票期權(“該等期權”)。該等購股權可按每股0.05美元的價格行使,為期5年。這些期權是根據本公司的激勵性股票期權計劃授予的,並受該計劃的條款管轄。

About Nova Mentis Life Science Corp.
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).

關於Nova Mentis生命科學公司
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
Subsidiary of Wellbeing Digital Sciences Inc, (Neo.MEDI) (OTC.KONEF), 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 the nutraceutical, cannabis and emerging psychedelic industries. 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. On an approximate basis, the business to date has produced 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.

關於KGK Science
KGK是WellBeing Digital Science Inc.(Neo.MEDI)(OTC.KONEF)的子公司,是北美領先的合同研究機構,總部設在安大略省倫敦市,主要提供高質量的臨牀研究試驗,重點放在營養食品、大麻和新興迷幻行業。該業務已成功幫助數百家公司進行了定製設計的臨牀試驗,並聲稱實施了將產品推向全球市場的證實戰略。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。在大致的基礎上,該業務到目前為止已經出版了150份出版物,在40多個適應症上執行了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: .

有關更多信息,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。


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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