Nova Mentis Completes Production of Psilocybin Microdose Capsules
Nova Mentis Completes Production of Psilocybin Microdose Capsules
Company Plans to Submit Clinical Trial Application in Canada
該公司計劃在加拿大提交臨牀試驗申請
Vancouver, British Columbia--(Newsfile Corp. - September 15, 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 it has completed production of psilocybin microdose capsules in collaboration with the Toronto Institute of Pharmaceutical Technology (TIPT®).
温哥華,不列顛哥倫比亞省-(Newsfile Corp.-2022年9月15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,它已經與多倫多製藥技術研究所(TIPT®)合作完成了裸蓋菇素微劑量膠囊的生產。.
TIPT and NOVA have recently completed the manufacturing of an engineering quantity of the psilocybin microdose capsules that was used to confirm product specifications for the capsule. Production of the first stability lot followed and capsules are currently undergoing release testing this week to generate data required for a clinical trial application.
TIPT和Nova最近完成了工程量裸蓋菇素微劑量膠囊的製造,該膠囊用於確認膠囊的產品規格。隨後生產的第一批穩定性膠囊目前正在進行釋放測試,以產生臨牀試驗應用所需的數據。
NOVA is currently preparing to submit a clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD). NOVA's recent research results showed that a very low microdose formulation of the Company's psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects in a genetic model of FXS.
Nova目前正準備向加拿大衞生部提交一份臨牀試驗申請,用於評估裸蓋菇素微劑量治療脆性X綜合徵(FXS)的2A階段研究。FXS是自閉症譜系障礙(ASD)的主要遺傳原因。Nova公司最近的研究結果表明,該公司的裸蓋菇素藥物(NM-1001)的極低劑量配方顯著調節了FXS遺傳模型中的行為和認知缺陷。
"A major success for NOVA to achieve this critical drug development accomplishment! Our team is incredibly dedicated and focused on achieving our planned milestones as we work towards meeting our mission of diagnosing and treating chronic conditions such as autism spectrum disorder and fragile X syndrome," said Jacqueline McConnell, NOVA's Chief Operating Officer.
Nova首席運營官傑奎琳·麥康奈爾表示:“Nova取得了這一關鍵藥物開發成就的重大成功!我們的團隊非常敬業,專注於實現我們計劃的里程碑,同時我們努力實現診斷和治療自閉症譜系障礙和脆性X綜合徵等慢性疾病的使命。”
The Company has formed a tactical partnership with KGK Science Inc. to develop its psilocybin drug portfolio in Canada. 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. Both Companies plan to jointly submit the Health Canada clinical trial application.
該公司已經與KGK科學公司建立了戰術合作伙伴關係,以開發其在加拿大的裸蓋菇素藥物組合。KGK是一家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,重點是營養食品、大麻和新興的迷幻藥行業。兩家公司計劃聯合提交加拿大衞生部的臨牀試驗申請。
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. Furthermore, NOVA has manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization following drug approval.
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。此外,Nova還生產了大量純度>98%的裸蓋菇素,用於臨牀研究和藥物批准後的商業化。
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 TIPT
關於小費
The Toronto Institute of Pharmaceutical Technology (TIPT®) is North America's premier pharmaceutical institute of education, technology and research. We operate a fully compliant Health Canada-licensed GMP manufacturing and testing facility for solid dosage forms and liquid preparations.
多倫多製藥技術研究所(TIPT®)是北美首屈一指的教育、技術和研究製藥研究所。我們運營着一家完全符合加拿大衞生部許可的GMP生產和測試設施,用於固體劑型和液體制劑。
Since our inception in 1992, we have successfully established corporate partnerships with leading pharmaceutical companies worldwide and have provided innovative product development solutions uniquely supported by pragmatic institutional experts.
自1992年成立以來,我們已成功地與全球領先的製藥公司建立了企業合作伙伴關係,並提供了得到務實機構專家獨特支持的創新產品開發解決方案。
For more information, please visit: .
有關更多信息,請訪問:。
About KGK Science
關於KGK Science
Founded in 1997, 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.
KGK成立於1997年,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