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St. Michael's Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

St. Michael's Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

聖邁克爾醫院加入針對心臟外科相關急性腎損傷的LSALT肽的II期試驗
GlobeNewswire ·  04/16 07:14

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced today that a research team from St. Michael's Hospital, a site of Unity Health Toronto, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

多倫多,2024年4月16日(GLOBE NEWSWIRE)——Arch Biopartners Inc.(“Arch” 或 “公司”)(多倫多證券交易所風險投資公司:ARCH 和OTCQB:ACHFF)今天宣佈,多倫多Unity Health所在地聖邁克爾醫院的研究小組已加入針對預防和治療心臟手術相關急性腎損傷(CS-AKI)的LSALT肽的二期試驗。LSALT 肽是該公司預防和治療腎臟、肺部和肝臟炎症損傷的主要候選藥物。

"Our research team is excited to be participating in this trial. Organ injury and repair is a Unity Health Toronto Research Pillar, and we are committed to investigating key mechanisms underlying tissue injury and healing, and to developing therapies to reduce injury and enhance regeneration," said Dr. David Mazer, translational researcher, anesthesiologist, and intensivist at St. Michael's Hospital.

“我們的研究團隊很高興能參與這項試驗。器官損傷和修復是多倫多Unity Health的研究支柱,我們致力於研究組織損傷和癒合的關鍵機制,並開發減少損傷和增強再生的療法。” 聖邁克爾醫院轉化研究員、麻醉師和重症監護醫生戴維·馬澤博士說。

The St. Michael's Hospital clinical team is awaiting ethics approval prior to beginning enrolment in the trial.

在開始註冊該試驗之前,聖邁克爾醫院的臨床團隊正在等待倫理批准。

The addition of St. Michael's as the third Canadian clinical site increases the number of trial sites to nine, with six hospitals in Turkey currently recruiting patients.

將聖邁克爾作爲加拿大的第三個臨床場所使試驗地點的數量增加到九個,土耳其目前有六家醫院正在招募患者。

The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

CS-AKI II 期試驗是一項國際多中心、隨機、雙盲、安慰劑對照的 LSALT 肽研究。該試驗的招募目標是240名患者。該試驗的主要目標是評估按KDIGO(腎臟疾病:改善全球預後)標準定義的體外(心肺機)心臟手術後七天內患有AKI的受試者的百分比。

Details of the Phase II trial, entitled "Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery" can be viewed at clinicaltrials.gov.

二期試驗的詳細信息,標題爲”用於預防或減輕體外科患者急性腎損傷(AKI)的LSALT肽的2期全球、多中心、隨機、雙盲、安慰劑對照研究” 可以在 clinicaltrials.gov 上查看。

Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide

心臟手術相關急性腎損傷 (CS-AKI) 和 LSALT 肽

CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

CS-AKI 通常由缺血再灌注損傷 (IRI) 引起,導致血流減少(缺血),從而減少腎臟中的氧氣,從而導致腎細胞損傷。一旦血流恢復正常(再灌注),就會引發炎症,加劇對腎細胞的損傷。在AKI的最壞情況下,腎臟衰竭,導致腎臟透析或腎臟移植。當今市場上沒有治療方法可以預防體外心臟手術患者常見的急性腎損傷。

LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et. al. and can be found along with previous peer-reviewed publications about DPEP-1 and LSALT peptide at the company's website.

LSALT肽靶向二肽酶-1(DPEP-1)途徑,Arch科學家及其合作者在臨床前模型(視頻)中證明LSALT肽可以防止腎臟的IRI,這爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現細節發表在該雜誌上, 《科學進展》,標題爲”二肽酶-1 控制缺血再灌注損傷期間的腎臟炎症“由劉等人撰寫,可以在該公司的網站上找到之前關於 DPEP-1 和 LSALT 肽的同行評審出版物。

Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial.

該公司於2023年3月宣佈的加拿大國家研究委員會工業研究援助計劃(NRC-IRAP)的諮詢服務和撥款將大大抵消CS-AKI二期試驗的成本。

Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI)

心臟手術相關急性腎損傷 (CS-AKI) 的發病率

Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality.

急性腎損傷(AKI)是冠狀動脈旁路移植術(CABG)和其他心臟手術(包括增加急性心肌梗死風險的體內手術)後患者的常見併發症。報告的CS-AKI患病率高達30%,與發病率和死亡率的增加獨立相關。

About Arch Biopartners

關於 Arch Biopart

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

Arch Biopartners Inc. 是一家後期臨床試驗公司,專注於預防炎症和急性器官損傷。該公司正在開發新的候選藥物,該藥物可通過二肽酶-1(DPEP-1)途徑抑制肺部、腎臟和肝臟的炎症,並與器官炎症尚未得到解決的常見損傷和疾病有關。

For more information on Arch Biopartners' science and technologies, please visit:

有關Arch Biopartners科學和技術的更多信息,請訪問:

For investor information and other public documents the company has also filed on SEDAR+, please visit

有關投資者信息以及該公司也在SEDAR+上提交的其他公開文件,請訪問

The Company has 62,855,633 common shares outstanding.

該公司有62,855,633股已發行普通股。

Forward-Looking Statements

前瞻性陳述

This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok), the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management's current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading "Business Risks and Uncertainties". As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval ("SEDAR") website at .

本新聞稿包含適用的加拿大證券法所指的前瞻性陳述,內容涉及我們對未來業績、流動性和資本資源的預期,以及針對二肽酶-1(DPEP-1)途徑的候選藥物的持續臨床開發,包括我們與LSALT肽(Metablok)相關的臨床試驗結果、候選藥物的成功商業化和上市、我們是否會獲得監管部門批准的時間和成本加拿大、美國各州、歐洲和其他國家、我們籌集資金爲商業計劃提供資金的能力、我們的候選藥物與競爭對手開發的候選藥物相比的療效、我們留住和吸引關鍵管理人員的能力,以及我們知識產權組合的廣度和保護能力。這些報表基於管理層當前的預期和信念,包括某些因素和假設,如我們最新的年度經審計的財務報表以及在 “業務風險和不確定性” 標題下的相關管理討論和分析中所述。由於這些風險和不確定性或其他未知風險和不確定性,我們的實際業績可能與任何前瞻性陳述中包含的結果存在重大差異。“相信”、“可能”、“計劃”、“將”、“估計”、“繼續”、“預期”、“打算”、“期望” 等詞語旨在識別前瞻性陳述,儘管並非所有前瞻性陳述都包含這些識別性詞語。除非法律要求,否則我們沒有義務更新前瞻性陳述。有關Arch Biopartners Inc. 的其他信息,包括我們最新的年度經審計的財務報表,可訪問加拿大證券管理局電子文件分析和檢索系統(“SEDAR”)網站,網址爲。

The science and medical contents of this release have been approved by the Company's Chief Science Officer

本新聞稿的科學和醫學內容已獲得公司首席科學官的批准

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

多倫多證券交易所風險交易所及其監管服務提供商(該術語在多倫多證券交易所風險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

CONTACT: For more information, please contact:   Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
聯繫人:欲了解更多信息,請聯繫:理查德·穆魯夫首席執行官 Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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