Global Wellness Readies for First Clinical Trial
Global Wellness Readies for First Clinical Trial
Shanti's Focus on Chronic Pain Market with Psychedelics
善帝專注於迷幻藥的慢性疼痛市場
Vancouver, British Columbia--(Newsfile Corp. - May 12, 2022) - Global Wellness Strategies Inc. (CSE: GWS) (OTCQB: GWSFF) (FSE: O3X) ("Global" or the "Company") announces Shanti Therapeutics MDMA Clinical Trial Update.
温哥華,不列顛哥倫比亞省-(Newsfile Corp.-2022年5月12日)-全球健康戰略公司。 (CSE:GWS)(OTCQB:GWSFF)(FSE:O3X)(“全球”或“公司”)宣佈Shanti Treateutics MDMA臨牀試驗更新。
Shanti's product suite of MDMA could be the global market winner finding a solution to the chronic puzzle of pain.
Shanti的MDMA產品套裝可能成為全球市場的贏家,找到了解決長期痛苦之謎的辦法。
iNGENü, a subsidiary of Australian leader Cannvalate, is engaged as the CRO (clinical research organization) by the Company to conduct clinical trials for Shanti Therapeutics. The protocol is a single center, randomized crossover study to investigate the efficacy of MDMA vs placebo in a model of experimental pain in healthy adults. Shanti has a targeted research pathway to clinical success, with strong proprietary protection under its already submitted patent providing a method for the treatment or prevention of pain.
Ingenü是澳大利亞領軍企業Cannvalate的子公司,被公司聘請為臨牀研究機構,為Shanti治療進行臨牀試驗。該方案是一項單中心、隨機交叉研究,旨在研究MDMA與安慰劑在健康成年人實驗性疼痛模型中的療效。Shanti有一條通往臨牀成功的有針對性的研究途徑,其已經提交的專利提供了治療或預防疼痛的方法,具有強大的專利保護。
The Shanti Key Opinion Leader (KOL) Dr. Michael Keane, who is a specialist anesthesiologist announced in November 2021, has already assembled the Shanti team with a wealth of data to support the potential development of a new generation of drugs to help patients suffering from chronic pain. He is the author of multiple MDMA articles, published in peer-reviewed scientific journals.
As previously announced in November 2021, Shanti submitted an application to Swinburne University (Melbourne, Australia) to the University Institutional Review Board (IRB) or HREC committee. The purpose of the HREC (Human Research Ethics Committee) review is to ensure that all clinical trials are conducted in accordance with Good Clinical Practice (GCP) and pose minimal safety concerns for the trial participants.
iNGENü, on behalf of Shanti as the sponsor of the trials, will begin the selection of the 22 healthy volunteers shortly in Australia for the trial; comparing the pain tolerance threshold in patients who have had exposure to a proprietary dose and formulation of MDMA.
iNGENü signed a supply agreement in February 2022 with Canada-based PharmAla Biotech to supply MDMA for the Shanti Therapeutics upcoming clinical trial and will disclose receipt of MDMA when appropriate.
Shanti Key Options Leader(KOL)博士是2021年11月宣佈的專業麻醉師,他已經用豐富的數據召集了Shanti團隊,以支持新一代藥物的潛在開發,以幫助患有慢性疼痛的患者。他是多篇MDMA文章的作者,發表在同行評議的科學期刊上。
正如之前在2021年11月宣佈的那樣,Shanti向Swinburne大學(澳大利亞墨爾本)向大學機構審查委員會(IRB)或HREC委員會提交了申請。HREC(人類研究倫理委員會)審查的目的是確保所有臨牀試驗都按照良好臨牀實踐(GCP)進行,並將對試驗參與者的安全擔憂降至最低。
Ingenü將代表Shanti作為試驗贊助商,不久將在澳大利亞開始挑選22名健康志願者進行試驗;比較接觸過專有劑量和MDMA配方的患者的疼痛耐受閾值。
Ingenü於2022年2月與總部位於加拿大的PharmAla Biotech簽署了一項供應協議,為Shanti Treateutics即將進行的臨牀試驗提供MDMA,並將在適當時披露MDMA的接收情況。
The Company is excited to be working with iNGENü and Shanti on the development of a novel drug to be used in the treatment of perioperative pain. Psychosocial elements can exacerbate the perception of pain but similarly, pain can often have significant psychological sequelae and lead to prolonged mental health issues. Depression, anxiety and other mental health issues often coexist with pain syndromes by the time they present to the treating physician.
該公司很高興能與Ingenü和Shanti合作開發一種用於治療圍手術期疼痛的新藥。心理社會因素會加劇對疼痛的感知,但同樣,疼痛往往會產生嚴重的心理後遺症,並導致長期的心理健康問題。當疼痛症狀出現在治療醫生面前時,抑鬱、焦慮和其他心理健康問題往往會與疼痛症狀並存。
"Developing a novel pharmaceutical compound for the treatment of perioperative pain is an exciting journey. We are thrilled at the progress of our subsidiary to date and look forward to the commencement of the initial dosing in this first-in-man trial," stated, Meris Kott, CEO, Global Wellness Strategies Inc.
Global Wellness Strategy Inc.首席執行官梅里斯·科特表示:“開發一種用於治療圍手術期疼痛的新型藥物化合物是一段令人興奮的旅程。我們對我們子公司迄今為止的進展感到興奮,並期待着在這項首例人體試驗中開始最初的劑量。”
About Global Wellness Strategies
Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.
關於全球健康戰略
Global Wellness Strategy是一個前景創造者,在快速增長的健康消費品市場為高增長的公司提供財務、運營和管理方面的幫助。該公司專注於全球健康、迷幻藥、真菌學、大麻和CBD,以及與醫療保健相關的目標公司。
For further information visit websites:
and
欲瞭解更多信息,請訪問以下網站:
和
Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com
或聯繫Meris Kott首席執行官604.484.0355,或發送電子郵件至info@global alwell nessstrategies.com
Further information about the Company is available on under the Company's profile.
欲瞭解更多有關本公司的信息,請訪問:本公司簡介。
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute "forward-looking statements" or "forward-looking information" (collectively "forward-looking information") as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "anticipates" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.
加拿大證券交易所及其監管服務提供商(該術語在加拿大證券交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。本新聞稿中包含的某些陳述可能構成“前瞻性陳述”或“前瞻性信息”(統稱為“前瞻性信息”),因為這些術語在1995年的“私人證券訴訟改革法”和類似的加拿大法律中使用。這些陳述與未來的事件或未來的表現有關。使用“可能”、“打算”、“預期”、“相信”、“將”、“預計”、“估計”、“預期”以及與非歷史事實有關的類似表述和陳述,旨在識別前瞻性信息,並基於公司對此類未來事件的結果和時機的當前信念或假設。未來的實際結果可能會有很大不同。特別是,本新聞稿包含與該公司的業務、其融資和某些公司變化有關的前瞻性信息。本新聞稿中包含的前瞻性信息是截至本新聞稿發佈之日的信息,公司沒有義務因新信息、未來事件或其他原因而更新或修改任何前瞻性信息,除非適用的證券法要求這樣做。由於本文包含的風險、不確定性和假設,投資者不應過度依賴前瞻性信息。上述陳述明確表示,本文中包含的任何前瞻性信息都是合格的。
To view the source version of this press release, please visit
要查看本新聞稿的源版本,請訪問
譯文內容由第三人軟體翻譯。