Nova Mentis Provides Corporate Update and 2023 Outlook
Nova Mentis Provides Corporate Update and 2023 Outlook
Vancouver, British Columbia--(Newsfile Corp. - April 5, 2023) - 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 provide a corporate update, including planned catalysts for 2023.
温哥华,不列颠哥伦比亚省-(Newsfile Corp.-2023年4月5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,在一流的基于裸盖菇素的疗法和神经炎性疾病的补充诊断方面处于全球领先地位,很高兴提供公司的最新情况,包括计划在2023年使用的催化剂。
"NOVA executed on several key research and drug development milestones in 2022, which has set the stage for a meaningful 2023. Our focus remains on advancing our proprietary psilocybin drug (NM-1001) and conducting the first-ever human trial evaluating the safety and efficacy of oral microdose psilocybin therapy for fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD)," says William Rascan, NOVA's President & CEO.
Nova总裁兼首席执行官威廉·拉斯坎表示:“Nova在2022年执行了几项关键的研究和药物开发里程碑,这为有意义的2023年奠定了基础。我们的重点仍然是推进我们的专有裸盖菇素药物(NM-1001),并进行有史以来第一次人体试验,评估口服微剂量裸盖菇素治疗脆性X综合征的安全性和有效性。脆性X综合征是自闭症谱系障碍的主要遗传原因。”
"We look forward to a busy 2023 as we continue in our efforts to deliver new and life-changing therapies for those with autism, the fastest growing developmental disability in the world. We believe psilocybin has the potential to offer new hope to patients who are searching for safe and effective treatment solutions to help with the behavioural and cognitive symptoms associated with autism," says Dr. Marvin S. Hausman, the Chairman of NOVA's Scientific Advisory Board.
Nova科学咨询委员会主席马文·S·豪斯曼博士说:“我们期待着2023年的忙碌,因为我们继续努力为自闭症患者提供新的、改变生活的疗法。自闭症是世界上增长最快的发展性残疾。我们相信裸盖菇素有潜力为那些正在寻找安全有效的治疗方案来帮助缓解与自闭症相关的行为和认知症状的患者带来新的希望。”
"I joined the NOVA team this year because I see the incredible potential of this new area of medicine and was impressed with the accomplishments NOVA achieved in such a short amount of time. From promising preclinical data and securing Orphan Drug status, to producing a large supply of synthetic psilocybin and earning Health Canada approval for a human study - the level of promise ahead of us is very exciting," says Derek Ivany, NOVA's Executive Chairman.
Nova执行主席德里克·伊万尼说:“我今年加入Nova团队,是因为我看到了这一新医学领域令人难以置信的潜力,并对Nova在如此短的时间内取得的成就印象深刻。从承诺临床前数据和获得孤儿药物地位,到生产大量合成裸盖菇素并获得加拿大卫生部批准进行人体试验--我们面前的承诺水平非常令人兴奋。”
The Nova 2022 Story: Accomplishments
新星2022的故事:成就
Formed a tactical partnership with KGK Science Inc. to develop NOVA's psychedelic psilocybin drug portfolio in Canada and jointly submit a psilocybin clinical trial application to Health Canada.
Successfully completed an oral microdose psilocybin preclinical study in the laboratory of Dr. Viviana Trezza at Rome Tre University in Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company's proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS.
Begun the patient enrollment process and enrolled 100+ participants into NOVA's North American Observational study: Establishing a Diagnostic and Therapeutic Index in ASD and FXS.
Partnered with the Toronto Institute of Pharmaceutical Technology (TIPT) to complete production of a large supply of >98% pure psilocybin capsules for clinical studies and commercialization following drug approval.
Received the necessary permits from Health Canada and the U.S. Drug Enforcement Administration (DEA) to ship the Company's proprietary psilocybin drug (NM-1001) from its manufacturing partner to the labs at TIPT.
Signed a research agreement with the University of Central Florida (UCF) Research Foundation to develop a saliva serotonin assay that will measure serotonin levels in the saliva samples collected as part of NOVA's autism observational study.
Bolstered its IP with the filing of provisional patent applications to protect data it obtained during its psilocybin preclinical studies and provide protection for the Company's therapeutic paradigm for treating neuroinflammatory disorders with psilocybin and psilocybin-based tryptamine derivatives.
Submitted to Health Canada the first-ever Phase IIA clinical trial application testing the safety and efficacy of oral microdose psilocybin therapy for FXS.
NOVA's psilocybin preclinical study results were published in Psychopharmacology, a fully peer-reviewed, international science journal.
Received Health Canada approval for first-of-its-kind psilocybin ASD clinical trial. The human study will evaluate the Company's proprietary psilocybin drug (NM-1001) in the treatment of FXS.
与KGK Science Inc.建立了战术合作伙伴关系,以开发Nova在加拿大的迷幻裸盖菇素药物组合,并联合向加拿大卫生部提交裸盖菇素临床试验申请。
在意大利罗马大学Viviana Trezza博士的实验室里,成功完成了口服微剂量裸盖菇素的临床前研究。结果超出了所有人的预期,发现非常低剂量的该公司专利裸盖菇素药物(NM-1001)显著调节了FXS遗传模型中的行为和认知缺陷,如识别记忆。
开始了患者登记过程,并招募了100多名参与者参加Nova的北美观察性研究:建立ASD和FXS的诊断和治疗指标。
与多伦多制药技术研究所(TIPT)合作,完成了大量供应>98%纯裸盖菇素胶囊的生产,用于临床研究和药物批准后的商业化。
获得加拿大卫生部和美国禁毒署(DEA)的必要许可,将该公司的裸盖菇素专利药物(NM-1001)从其制造合作伙伴运往TIPT的实验室。
与中佛罗里达大学(UCF)研究基金会签署了一项研究协议,开发一种唾液5-羟色胺检测方法,该方法将测量作为Nova自闭症观察研究一部分收集的唾液样本中的5-羟色胺水平。
通过提交临时专利申请支持其知识产权,以保护其在裸盖菇素临床前研究期间获得的数据,并为公司使用裸盖菇素和基于裸盖菇素的色胺衍生物治疗神经炎性疾病的治疗范例提供保护。
向加拿大卫生部提交了有史以来第一个IIA期临床试验申请,测试口服微剂量裸盖菇素治疗FXS的安全性和有效性。
Nova的裸盖菇素临床前研究结果发表在《精神药理学》上,这是一本完全由同行评审的国际科学杂志。
获得加拿大卫生部批准,进行首个裸盖菇素ASD临床试验。这项人体研究将评估该公司治疗FXS的裸盖菇素专利药物(NM-1001)。
Anticipated 2023 Milestones:
预计2023年的里程碑:
2023 kicked off with promising developments, as NOVA received an exemption under Section 56 of Canada's Controlled Drugs and Substances Act allowing the Company to proceed with the first-ever Phase IIA clinical trial assessing repetitive, oral microdose psilocybin therapy for adults with fragile X.
2023年以良好的进展拉开序幕,Nova根据加拿大《受控药物和物质法案》第56条获得豁免,允许该公司继续进行有史以来第一个IIA期临床试验,评估针对患有脆性X的成年人的重复口服微剂量裸盖菇素疗法。
Other planned catalysts for 2023 include:
2023年计划的其他催化剂包括:
Recruiting participants for NOVA's Health Canada approved psilocybin study in fragile X syndrome.
Evaluating potential corporate partners with interest in NOVA's psilocybin drug portfolio and clinical research supplies.
Nova‘s Health Canada的招募参与者批准了裸盖菇素在脆性X综合征中的研究。
评估对Nova的裸盖菇素药物组合和临床研究用品感兴趣的潜在企业合作伙伴。
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 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FXS的孤儿药物指定的生物技术公司。
NOVA's goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as ASD and FXS.
Nova的目标是诊断和治疗尚未满足医疗需求的慢性疾病,如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。
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
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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。
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