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Braxia Scientific Receives Health Canada Special Access Program Approval to Provide Psilocybin-Assisted Therapy for Depression in Ontario

Braxia Scientific Receives Health Canada Special Access Program Approval to Provide Psilocybin-Assisted Therapy for Depression in Ontario

BraxiaScience获得加拿大卫生部特别准入计划批准,将在安大略省提供裸盖菇素辅助抑郁症治疗
PR Newswire ·  2022/05/20 08:00
  • Health Canada approval is for a patient with the indication of Major Depressive Disorder, in the absence of terminal medical illness or end of life distress
  • 健康状况加拿大批准适用于有严重抑郁障碍迹象的患者,在没有晚期疾病或生命垂危的情况下
  • Approval marks Braxia's first Special Access Program (SAP) approval for use of psilocybin in Ontario.
  • BRAXIA的批准标志着第一个特别准入计划(SAP)批准在安大略省.
  • To date Braxia's experienced therapists have delivered psilocybin-assisted therapy treatments to 16 individuals with depression through its proprietary clinical trial commenced late 2021.
  • 到目前为止,Bracia的经验丰富的治疗师已经通过其2021年底开始的专有临床试验,为16名抑郁症患者提供了裸盖菇素辅助治疗。

TORONTO, May 20, 2022 /PRNewswire/ - Braxia Scientific Corp. ("Braxia Scientific", or the "Company"), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing and advancing innovative ketamine and other innovative treatments for people living with depression and related mental health disorders. Braxia Scientific is pleased to announce that Health Canada has approved the Company's application to the Special Access Program ("SAP") to provide psilocybin-assisted psychotherapy for a patient with Major Depressive Disorder in Ontario, through its wholly owned subsidiary Canadian Rapid Treatment Centre of Excellence (CRTCE).

多伦多,2022年5月20日/美通社/-布拉夏科学公司(“布拉夏科学公司”,或“公司”),(CSE:BRAX)(场外交易代码:BRAXF)(FWB:4960),一家医疗研究公司,其诊所为抑郁症患者和相关精神健康障碍患者提供和推进创新型氯胺酮和其他创新疗法。布拉夏科学公司高兴地宣布,加拿大卫生部已经批准了该公司向特别准入计划(“SAP”)提出的通过其全资子公司加拿大卓越快速治疗中心(CRTCE)为安大略省一名严重抑郁症患者提供裸盖菇素辅助心理治疗的申请。

While this is Braxia Scientific's first psilocybin-assisted therapy treatment approval using Health Canada's SAP, which was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials, Braxia Scientific was first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, dosing its first participant in November 2021. To date, the Company has provided psilocybin-assisted therapy to 16 individuals living with depression.

虽然这是BraxiaScience第一次批准裸盖菇素辅助治疗,使用的是加拿大卫生部的SAP,该批准于1月5日修订这是,2022将迷幻化合物的使用包括在临床试验之外的个案基础上,BraxiaScience是第一个获得加拿大卫生部批准的多剂量裸盖菇素辅助治疗临床试验的公司2021年7月,在2021年11月给第一个参与者服药。到目前为止,该公司已经为16名抑郁症患者提供了裸盖菇素辅助治疗。

"Being among the first to begin delivering psilocybin-assisted therapy treatments in Canada last year through our clinical trial, we have developed and optimized the infrastructure, including rigorous training for our therapists through our Braxia Institute, to provide a positive patient experience while optimizing outcomes, said Dr. Joshua Rosenblat, Chief Medical and Scientific Officer, Braxia Scientific. "To our knowledge, this is the first Health Canada SAP approval for psilocybin-assisted therapy for a person with Major Depressive Disorder in Ontario. My patient and I are extremely grateful for this opportunity to access this promising treatment. Health Canada was very responsive to this request, promptly providing the Letter of Authorization. This rapid approval stands in contrast  to the previously required Section 56 exemptions that could take years to fully process. Allowing use of the SAP will be incredibly beneficial for patients in need of this treatment that are unable to receive it through psychedelic clinical trials."

“作为去年开始在加拿大通过我们的临床试验提供裸盖菇素辅助治疗的首批公司之一,我们已经开发和优化了基础设施,包括通过我们的布拉夏研究所对我们的治疗师进行严格的培训,以提供积极的患者体验,同时优化结果。约书亚·罗森布拉特,布拉夏科学公司首席医学和科学官。据我们所知,这是加拿大卫生部第一次批准裸盖菇素辅助治疗安大略省的严重抑郁症患者。我的患者和我非常感谢有机会获得这种有希望的治疗。加拿大对这一要求非常响应,及时提供了授权书。这一快速批准与之前要求的第56条豁免形成了鲜明对比,后者可能需要数年时间才能完全处理。对于需要这种治疗的患者来说,允许使用SAP将是非常有益的,因为他们无法通过迷幻临床试验接受这种治疗。“

"Since opening our first clinic in 2018, in Toronto, Canada, our focus has been on creating a true centre of excellence for people living and suffering with depression to gain access to the most effective treatments. Our ability to deliver psilocybin-assisted therapy is an important step in our journey to achieving our vision of finding a cure for depression, said Dr. Roger McIntyre, Chairman and CEO, Braxia Scientific. "The experience of our therapists who have already delivered this novel treatment in multiple doses to multiple patients in our ongoing psilocybin trial, combined with data we've collected to date and expect to read out in the coming weeks, provides an excellent opportunity for new applicants to receive access to the most advanced clinical protocols and care to achieve best outcomes in this field. In addition to providing access to innovative treatments for depression, Braxia Scientific is a   leader in comprehensive research, development and best- practices  implementation of psilocybin, ketamine and related agents."

自2018年在加拿大多伦多开设第一家诊所以来,我们的重点一直是为抑郁症患者创建一个真正的卓越中心,以获得最有效的治疗。我们提供裸盖菇素辅助治疗的能力是我们实现找到抑郁症治疗方法的愿景的重要一步。罗杰·麦金太尔,布拉夏科学公司董事长兼首席执行官。我们的治疗师已经在我们正在进行的裸盖菇素试验中向多名患者提供了这种新型治疗方法,他们的经验与我们迄今收集的数据相结合,预计将在未来几周内公布,这为新申请者提供了一个极好的机会,使他们能够获得最先进的临床方案和护理,以在这一领域取得最佳结果。除了提供治疗抑郁症的创新疗法之外,BraxiaScience公司还在裸盖菇素、氯胺酮和相关药物的综合研究、开发和最佳实践实施方面处于领先地位。“

Canadians interested in applying to the SAP, to participate in clinical trials or to qualify for other treatments, such as IV and oral Ketamine for the treatment of depression, may contact the medical team at Braxia Health (the Canadian Rapid Treatment Centre of Excellence

有兴趣向SAP申请、参加临床试验或有资格接受其他治疗方法的加拿大人,如用于治疗抑郁症的静脉注射和口服氯胺酮,可以联系Braxia Health(加拿大卓越快速治疗中心)的医疗团队

About Braxia Scientific Corp.
布拉夏科学公司简介

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

布拉夏科学公司是一家医学研究公司,拥有为抑郁症和相关疾病患者提供创新型氯胺酮治疗的诊所。通过其医疗解决方案,Braxia旨在减轻以大脑为基础的疾病的疾病负担,如严重的抑郁症等。Braxia主要专注于(I)拥有和经营多学科诊所,为精神健康障碍提供治疗,以及(Ii)与发现和商业化新药和给药方法有关的研究活动。布拉夏寻求从其知识产权开发平台开发氯胺酮及其衍生物和其他迷幻产品。通过其全资子公司加拿大卓越快速治疗中心公司,Bracia目前在密西索加经营着多学科社区诊所,为抑郁症提供快速有效的治疗,多伦多、渥太华和蒙特利尔.

ON BEHALF OF THE BOARD

我代表董事会

"Dr. Roger S. McIntyre"

“罗杰·S·麦金太尔博士”

Dr. Roger S. McIntyre

罗杰·S·麦金太尔博士

Chairman & CEO

董事长兼首席执行官

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

CSE未对本新闻稿的准确性或充分性进行审查,也不承担任何责任。

Forward-looking Information Cautionary Statement
前瞻性信息警示声明

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are "forward-looking statements."

本新闻稿包含符合适用证券法的前瞻性陈述。所有不是历史事实、未来估计、计划、计划、预测、预测、目标、假设、预期或对未来业绩的信念的陈述都是“前瞻性陈述”。

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the "CDSA") and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

前瞻性陈述包括关于以氯胺酮为基础的抑郁症治疗的预期承诺,以及氯胺酮治疗其他新出现的精神障碍的可能性,如双相抑郁。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,可能导致实际结果、事件或发展与此类前瞻性表述明示或暗示的任何未来结果、事件或发展大相径庭。除其他外,这些风险和不确定性包括氯胺酮、裸盖菇素和其他迷幻剂未能提供预期的健康益处和意想不到的副作用,依赖于获得和维持监管批准,包括获得和续签联邦、省、市、地方或其他许可证,以及从事后来根据国内或国际法可能被认定为非法的活动。氯胺酮和裸盖菇素目前分别是《受控药物和物质法》(《受控药物和物质法》,S.C.1996,c.19)规定的附表一和附表三的受控物质,根据《受控药物和物质法》,在没有处方或法律豁免的情况下拥有这类物质是刑事犯罪。加拿大卫生部尚未批准裸盖菇素作为任何适应症的药物,但氯胺酮是法律允许用于治疗某些心理疾病的药物。在中国拥有这种物质是违法的加拿大没有处方的话。

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company's filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at . There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

这些因素应仔细考虑,并告诫读者不要过度依赖此类前瞻性陈述。尽管公司试图确定可能导致实际行动、事件或结果与前瞻性陈述中描述的大不相同的重要风险因素,但可能存在其他风险因素,导致行动、事件或结果与预期、估计或预期的不同。识别可能影响财务业绩的风险和不确定性的其他信息包含在公司提交给加拿大证券监管机构的文件中,包括日期为2021年4月15日的修订和重新发布的上市声明,这些文件可在以下网址查阅。不能保证前瞻性陈述将被证明是准确的,因为实际结果和未来事件可能与前瞻性陈述中预期的大不相同。

SOURCE Braxia Scientific Corp.

来源:布拉夏科学公司

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