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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

新曼蒂斯裸盖菇素微剂量胶囊制剂将提交加拿大卫生部第2A期临床试验申请
newsfile ·  2022/09/29 08:40

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.

温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2022年9月29日)-Nova Mentis生命科学公司(CSE:NOVA)(FSE:HN3Q)(OTCQB:NMLSF)(“Nova”或“公司”),一家生物技术公司和一流的以裸盖菇素为基础的疗法和神经炎性疾病辅助诊断的全球领先企业高兴地宣布,该公司已经生产了1.5毫克裸盖菇素微剂量胶囊。这些胶囊是根据化学、制造和控制(CMC)发布的指南中概述的定义的制造工艺和产品规格生产的。

"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公司首席运营官杰奎琳·麦康奈尔说:“Nova公司通过生产GMP级裸盖菇素微剂量胶囊,在其自闭症谱系障碍(ASD)临床研究计划方面取得了重大突破。Nova还很高兴开始向加拿大的医生、诊所和制药公司提供1.5毫克裸盖菇素胶囊,用于非自闭症临床试验的潜在治疗用途,包括但不限于糖尿病、心脏病、癫痫和创伤后应激障碍(PTSD)。Nova和KGK Science Inc.(KGK)可以协助创建未来的临床试验申请,并将其提交加拿大卫生部审查。

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公司手头有一套完整的CMC包,用于支持2A期微剂量裸盖菇素脆性X综合征(FXS)的临床试验应用。将提交加拿大卫生部审查的一揽子计划包括:

  • 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.
  • 裸盖菇素活性药物成分(原料药)第二阶段制造工艺文件。
  • 确认最终胶囊批次已经生产的成品批次生产记录。
  • 裸盖菇素胶囊的溶出度参数符合法规要求。

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及其临床研究组织(CRO)合作伙伴KGK目前正在敲定临床试验申请,该申请将提交给加拿大卫生部批准一项评估裸盖菇素微剂量疗法治疗FXS的第2A阶段研究。FXS是ASD的主要遗传原因。

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,本公司已向董事会成员、管理团队及本公司顾问授予合共4,600,000份激励性股票期权(“该等期权”)。该等购股权可按每股0.05美元的价格行使,为期5年。这些期权是根据本公司的激励性股票期权计划授予的,并受该计划的条款管辖。

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).

关于Nova Mentis生命科学公司
Nova Mentis生命科学公司是一家总部位于加拿大的生物技术公司,在开发神经炎性疾病的诊断和基于裸盖菇素的疗法方面处于全球领先地位。Nova是第一家在美国和欧盟获得使用裸盖菇素治疗脆性X综合征(FXS)的孤儿药物指定的生物技术公司。

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

我们的目标是诊断和治疗那些没有满足医疗需求的令人衰弱的慢性疾病,如自闭症谱系障碍(ASD)和FXS。

For further information on the Company, please visit or email info@novamentis.ca.

欲了解更多有关公司的信息,请访问或发送电子邮件至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.

关于KGK Science
KGK是WellBeing Digital Science Inc.(Neo.MEDI)(OTC.KONEF)的子公司,是北美领先的合同研究机构,总部设在安大略省伦敦市,主要提供高质量的临床研究试验,重点放在营养食品、大麻和新兴迷幻行业。该业务已成功帮助数百家公司进行了定制设计的临床试验,并声称实施了将产品推向全球市场的证实战略。KGK的其他现有服务包括专家监管支持和合规解决方案、参与者招聘、研究支持服务和咨询服务。在大致的基础上,该业务到目前为止已经出版了150份出版物,在40多个适应症上执行了400多项临床试验,在其数据库中积累了2.5万名参与者,并收集了1000万个数据点。

For more information, please visit: .

有关更多信息,请访问:。

On Behalf of the Board

我谨代表董事会

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

威尔·拉斯坎,总裁兼首席执行官
Nova Mentis生命科学公司

Phone: 778-819-0244
Toll Free: 1-833-542-5323

电话:778-819-0244
免费电话:1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

推特:@novamentislsc
Instagram:@novamentislsc
脸书:@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.

加拿大证券交易所及其市场监管机构(该术语在加拿大证券交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

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.

本新闻稿包含构成“前瞻性陈述”的陈述。此类前瞻性表述涉及已知和未知的风险、不确定性和其他因素,可能导致Nova Mentis生命科学公司的实际结果、业绩或成就或行业发展与此类前瞻性表述明示或暗示的预期结果、业绩或成就大不相同。前瞻性陈述是指不是历史事实的陈述,通常但并非总是由“预期”、“计划”、“预期”、“相信”、“打算”、“估计”、“项目”、“潜在”和类似的表述,或事件或条件“将”、“将”、“可能”、“可能”或“应该”发生。

To view the source version of this press release, please visit

要查看本新闻稿的源版本,请访问

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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