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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獲得加拿大衞生部特別准入計劃批准,將在安大略省提供裸蓋菇素輔助抑鬱症治療
PR Newswire ·  2022/05/20 20:00
  • 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
  • 健康狀況加拿大批准適用於有嚴重抑鬱障礙跡象的患者,在沒有晚期疾病或生命垂危的情況下
  • Approval marks Braxia's first Special Access Program (SAP) approval for use of psilocybin in Ontario.
  • BRAXIA的批准標誌着第一個特別准入計劃(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.
  • 到目前為止,Bracia的經驗豐富的治療師已經通過其2021年底開始的專有臨牀試驗,為16名抑鬱症患者提供了裸蓋菇素輔助治療。

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).

多倫多,2022年5月20日/美通社/-布拉夏科學公司(“布拉夏科學公司”,或“公司”),(CSE:BRAX)(場外交易代碼:BRAXF)(FWB:4960),一家醫療研究公司,其診所為抑鬱症患者和相關精神健康障礙患者提供和推進創新型氯胺酮和其他創新療法。布拉夏科學公司高興地宣佈,加拿大衞生部已經批准了該公司向特別准入計劃(“SAP”)提出的通過其全資子公司加拿大卓越快速治療中心(CRTCE)為安大略省一名嚴重抑鬱症患者提供裸蓋菇素輔助心理治療的申請。

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.

雖然這是BraxiaScience第一次批准裸蓋菇素輔助治療,使用的是加拿大衞生部的SAP,該批准於1月5日修訂這是,2022將迷幻化合物的使用包括在臨牀試驗之外的個案基礎上,BraxiaScience是第一個獲得加拿大衞生部批准的多劑量裸蓋菇素輔助治療臨牀試驗的公司2021年7月,在2021年11月給第一個參與者服藥。到目前為止,該公司已經為16名抑鬱症患者提供了裸蓋菇素輔助治療。

"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."

“作為去年開始在加拿大通過我們的臨牀試驗提供裸蓋菇素輔助治療的首批公司之一,我們已經開發和優化了基礎設施,包括通過我們的布拉夏研究所對我們的治療師進行嚴格的培訓,以提供積極的患者體驗,同時優化結果。約書亞·羅森布拉特,布拉夏科學公司首席醫學和科學官。據我們所知,這是加拿大衞生部第一次批准裸蓋菇素輔助治療安大略省的嚴重抑鬱症患者。我的患者和我非常感謝有機會獲得這種有希望的治療。加拿大對這一要求非常響應,及時提供了授權書。這一快速批准與之前要求的第56條豁免形成了鮮明對比,後者可能需要數年時間才能完全處理。對於需要這種治療的患者來説,允許使用SAP將是非常有益的,因為他們無法通過迷幻臨牀試驗接受這種治療。“

"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年在加拿大多倫多開設第一家診所以來,我們的重點一直是為抑鬱症患者創建一個真正的卓越中心,以獲得最有效的治療。我們提供裸蓋菇素輔助治療的能力是我們實現找到抑鬱症治療方法的願景的重要一步。羅傑·麥金太爾,布拉夏科學公司董事長兼首席執行官。我們的治療師已經在我們正在進行的裸蓋菇素試驗中向多名患者提供了這種新型治療方法,他們的經驗與我們迄今收集的數據相結合,預計將在未來幾周內公佈,這為新申請者提供了一個極好的機會,使他們能夠獲得最先進的臨牀方案和護理,以在這一領域取得最佳結果。除了提供治療抑鬱症的創新療法之外,BraxiaScience公司還在裸蓋菇素、氯胺酮和相關藥物的綜合研究、開發和最佳實踐實施方面處於領先地位。“

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

有興趣向SAP申請、參加臨牀試驗或有資格接受其他治療方法的加拿大人,如用於治療抑鬱症的靜脈注射和口服氯胺酮,可以聯繫Braxia Health(加拿大卓越快速治療中心)的醫療團隊

About Braxia Scientific Corp.
布拉夏科學公司簡介

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.

布拉夏科學公司是一家醫學研究公司,擁有為抑鬱症和相關疾病患者提供創新型氯胺酮治療的診所。通過其醫療解決方案,Braxia旨在減輕以大腦為基礎的疾病的疾病負擔,如嚴重的抑鬱症等。Braxia主要專注於(I)擁有和經營多學科診所,為精神健康障礙提供治療,以及(Ii)與發現和商業化新藥和給藥方法有關的研究活動。布拉夏尋求從其知識產權開發平臺開發氯胺酮及其衍生物和其他迷幻產品。通過其全資子公司加拿大卓越快速治療中心公司,Bracia目前在密西索加經營着多學科社區診所,為抑鬱症提供快速有效的治療,多倫多、渥太華和蒙特利爾.

ON BEHALF OF THE BOARD

我代表董事會

"Dr. Roger S. McIntyre"

“羅傑·S·麥金太爾博士”

Dr. Roger S. McIntyre

羅傑·S·麥金太爾博士

Chairman & CEO

董事長兼首席執行官

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

CSE未對本新聞稿的準確性或充分性進行審查,也不承擔任何責任。

Forward-looking Information Cautionary Statement
前瞻性信息警示聲明

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."

本新聞稿包含符合適用證券法的前瞻性陳述。所有不是歷史事實、未來估計、計劃、計劃、預測、預測、目標、假設、預期或對未來業績的信念的陳述都是“前瞻性陳述”。

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.

前瞻性陳述包括關於以氯胺酮為基礎的抑鬱症治療的預期承諾,以及氯胺酮治療其他新出現的精神障礙的可能性,如雙相抑鬱。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,可能導致實際結果、事件或發展與此類前瞻性表述明示或暗示的任何未來結果、事件或發展大相徑庭。除其他外,這些風險和不確定性包括氯胺酮、裸蓋菇素和其他迷幻劑未能提供預期的健康益處和意想不到的副作用,依賴於獲得和維持監管批准,包括獲得和續簽聯邦、省、市、地方或其他許可證,以及從事後來根據國內或國際法可能被認定為非法的活動。氯胺酮和裸蓋菇素目前分別是《受控藥物和物質法》(《受控藥物和物質法》,S.C.1996,c.19)規定的附表一和附表三的受控物質,根據《受控藥物和物質法》,在沒有處方或法律豁免的情況下擁有這類物質是刑事犯罪。加拿大衞生部尚未批准裸蓋菇素作為任何適應症的藥物,但氯胺酮是法律允許用於治療某些心理疾病的藥物。在中國擁有這種物質是違法的加拿大沒有處方的話。

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.

這些因素應仔細考慮,並告誡讀者不要過度依賴此類前瞻性陳述。儘管公司試圖確定可能導致實際行動、事件或結果與前瞻性陳述中描述的大不相同的重要風險因素,但可能存在其他風險因素,導致行動、事件或結果與預期、估計或預期的不同。識別可能影響財務業績的風險和不確定性的其他信息包含在公司提交給加拿大證券監管機構的文件中,包括日期為2021年4月15日的修訂和重新發布的上市聲明,這些文件可在以下網址查閲。不能保證前瞻性陳述將被證明是準確的,因為實際結果和未來事件可能與前瞻性陳述中預期的大不相同。

SOURCE Braxia Scientific Corp.

來源:布拉夏科學公司

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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