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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

Nova Mentis与KGK Science签订第二阶段A临床试验研究合同
newsfile ·  2022/11/17 08:30

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).

温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2022年11月17日)-Nova Mentis生命科学公司(CSE:NOVA)(OTCQB:NMLSF)(FSE:HN3Q)(“Nova”或“公司”),亚洲网加利福尼亚州圣何塞10月23日电一家生物技术公司和神经炎性疾病的一流基于裸盖菇素的疗法和补充诊断方面的全球领先企业高兴地宣布,它已经与健康数字科学公司的全资子公司KGK Sciences Inc.(KGK)达成了一项研究服务协议,以进行计划中的第二阶段A临床试验,以测试裸盖菇素对被诊断为脆性X综合征(FXS)的患者的疗效。

"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首席执行官总裁说:“Nova计划用裸盖菇素治疗FXS对我们公司来说是一个重要的药物开发里程碑。”我们相信,KGK在高质量临床研究试验方面的丰富经验和该领域的专家监管支持将使我们在成功治疗ASD和FXS方面取得相当大的进展,这两种疾病目前尚未得到满足。“

"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首席执行官纳吉拉·格思里评论说:“我们很高兴能与Nova Mentis合作,进行他们计划的第二阶段A期临床试验,以测试基于裸盖菇素的疗法对与FXS相关的行为和认知症状的疗效。在过去的25年里,我们成功地帮助了数百家公司进行定制设计的临床试验,并声称证实战略,将产品有效地推向全球市场。”

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.

开创性的II阶段A临床试验是第一项人类研究,调查了微剂量裸盖菇素改善与FXS相关的行为和认知症状的可能性。这项10人的开放标签研究的结果将用于支持Nova在FDA孤儿药物指定下的药物开发计划,该计划于2021年底收到。根据与Nova的研究和服务协议,KGK将提供研究服务,包括制定临床试验方案、提交监管和伦理报告、进行试验、数据管理和验证、统计分析和起草最终报告(“服务”)。临床试验计划在KGK位于加拿大安大略省伦敦市的专门研究机构进行。

Additional Information Regarding the Agreement

有关该协议的其他信息

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.

根据研究服务协议,KGK将提供临床研究组织服务,包括定制设计的临床试验方案,以监督公司计划的Health Canada II A期临床试验,并考虑到公司在达到某些业绩里程碑时发放公司的单位(“单位”),总金额高达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.

每个单位应包括一股本公司股本中的普通股(“股份”)和一份购买本公司股本中普通股的认股权证(“认股权证”)的一半。该等单位的发行价应视为等于(A)0.05美元及(B)本公司股份于发行时在加拿大证券交易所(“CSE”)的收市价减去CSE政策所容许的最大折让金额两者中较大者。该等认股权证的有效期为自发行起计两(2)年,每份整份认股权证可按相当于(A)0.075美元及(B)本公司股份于发行时在联交所的收市价中较大者的价格行使。这些单位自发行之日起有四个月零一天的持有期。

About Nova Mentis Life Science Corp.

关于Nova Mentis生命科学公司

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

关于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,是一家总部设在安大略省伦敦市的北美领先的合同研究机构,主要提供高质量的临床研究试验,重点是营养食品和新兴保健产品。该公司成立于1997年,已成功帮助数百家公司进行了定制设计的临床试验和声称的证实战略,以将产品推向全球市场。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。此外,该公司已经出版了150多份出版物,执行了40多个适应症的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: .

如需更多信息,请访问:.

About Wellbeing Digital Sciences

关于Welling数字科学

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.

幸福数字科学公司是一家以循证为基础的精神保健公司,专注于开发和实施创新的临床治疗解决方案,包括迷幻药物和数字疗法,并得到临床研究的支持。它的使命得到了北美诊所网络的支持,这些诊所向患者提供前瞻性治疗和其他类型的治疗,以及通过一个合同研究组织向寻求药物开发的客户提供临床试验服务。

For additional information, please visit:

欲了解更多信息,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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