Arch Biopartners Announces University of Calgary Ethics Approval to Proceed With Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI)
Arch Biopartners Announces University of Calgary Ethics Approval to Proceed With Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI)
TORONTO, June 18, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the University of Calgary's Conjoint Health Research Ethics Board (CHREB) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
2024年6月18日，多倫多（GLOBE NEWSWIRE）——Arch Biopartners公司（“Arch”或“公司”）（TSX Venture: ARCH和OTCQB: ACHFF）今天宣佈卡爾加里大學共同健康研究道德委員會（CHREB）已批准 LSALT肽針對心臟手術相關急性腎損傷（CS-AKI）的二期試驗。
The clinical team at the University of Calgary Cumming School of Medicine is now able to work with Arch to complete preparation and training to enable the start of patient recruitment in Calgary. This work will be completed while waiting for the expected final approval from Alberta Health Services.
卡爾加里大學哥明醫學院的臨床團隊現在能夠與Arch共同完成準備和培訓，以啓動在卡爾加里招募患者。在等待阿爾伯塔衛生服務機構的最終批准期間，將完成這項工作。
The trial continues to have patient recruitment at five clinical sites in Turkey. Since the trial began dosing patients in March, there have been enhancements to the design of the study protocol to help improve the execution of the trial. These changes have since been approved by Health Canada and are pending approval by the Turkish Ministry of Health.
該試驗繼續在土耳其的五個臨床研究中心進行患者招募。自從三月開始給科患者注射試劑以來，已對研究方案進行了改進，以幫助改進試驗的執行。這些變化已獲得了加拿大衛生機構的批准，並正在等待土耳其衛生部的批准。
Quote from Mr. Richard Muruve, CEO Arch Biopartners:
Arch Biopartners首席執行官Richard Muruve先生說：“我們很高興看到CHREB的倫理批准，期待卡爾加里醫院的CS-AKI 二期試驗招募患者。我們對土耳其的五個招募醫院的試驗進展滿意。加拿大首次注射試劑，先在卡爾加里醫院，隨後是我們在多倫多的兩個醫院，將爲整個試驗增添助力。
"We are happy to see the ethics approval from the CHREB and we are looking forward to the start of patient recruitment in our CS-AKI Phase II trial at the University of Calgary Hospital. We are satisfied with the progress made to date in the trial at our five actively recruiting hospital sites in Turkey. The start of dosing in Canada, first in Calgary and followed by our two sites in Toronto, will be a big boost to the trial overall."
Arch Biopartners首席執行官Richard Muruve先生說：“我們很高興看到CHREB的倫理批准，期待卡爾加里醫院的CS-AKI 二期試驗招募患者。我們對土耳其的五個招募醫院的試驗進展滿意。加拿大首次注射試劑，先在卡爾加里醫院，隨後是我們在多倫多的兩個醫院，將爲整個試驗增添助力。
About the CS-AKI Phase II Trial
CS-AKI 二期試驗簡介
The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients.
CS-AKI 二期試驗是一項國際多中心、隨機、雙盲、安慰劑對照研究，旨在招募240名患者，並研究LSALT肽的療效。
The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
該試驗的主要目標是根據KDIGO（腎臟疾病：改善全球結果）標準，評估經過體外循環（心肺機）心臟手術後七天內患急性腎損傷（AKI）的比例。
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.
有關“LSALT肽用於預防或減輕體外循環心臟手術患者急性腎損傷（AKI）的二期全球多中心、隨機、雙盲、安慰劑對照研究”試驗詳細信息，可在clinicaltrials.gov上查看。有關“LSALT肽用於預防或減輕體外循環心臟手術患者急性腎損傷（AKI）的二期全球多中心、隨機、雙盲、安慰劑對照研究”試驗詳細信息，可在clinicaltrials.gov上查看。有關“LSALT肽用於預防或減輕體外循環心臟手術患者急性腎損傷（AKI）的二期全球多中心、隨機、雙盲、安慰劑對照研究”試驗詳細信息，可在clinicaltrials.gov上查看。
CS-AKI and LSALT peptide
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. 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. In the worst cases of AKI, the kidneys fail, requiring kidney dialysis or kidney transplant for survival.
CS-AKI通常是由缺血再灌注損傷（IRI）引起的，它會降低腎臟中的血流量（缺血），從而引起腎細胞損傷。一旦血流恢復正常（再灌注），就會引發炎症並加重腎細胞的損傷。市場上目前沒有可用於預防術後體外循環心臟手術患者常見的急性腎損傷的治療。在最嚴重的AKI病例中，腎臟衰竭，需要腎透析或腎移植才能生存。
LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The drug targets the dipeptidase-1 (DPEP1) 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 the latest peer-reviewed publications about DPEP1 and LSALT peptide at the Company's website.
LSALT肽是公司用於預防和治療腎臟、肺部和肝臟炎症損傷的主要藥物候選物。該藥物靶向二肽酶-1（DPEP1）途徑，並被Arch科學家及其合作者證明可以在臨床前模型中預防腎臟缺血再灌注損傷（視頻），爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現詳見《Science Advances》雜誌，標題爲“Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury”的Lau et. al.，以及該公司網站上有關DPEP1和LSALT肽的最新同行評議的出版物。LSALT肽是公司用於預防和治療腎臟、肺部和肝臟炎症損傷的主要藥物候選物。該藥物靶向二肽酶-1（DPEP1）途徑，並被Arch科學家及其合作者證明可以在臨床前模型中預防腎臟缺血再灌注損傷（視頻），爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現詳見《Science Advances》雜誌，標題爲“Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury”的Lau et. al.，以及該公司網站上有關DPEP1和LSALT肽的最新同行評議的出版物。LSALT肽是公司用於預防和治療腎臟、肺部和肝臟炎症損傷的主要藥物候選物。該藥物靶向二肽酶-1（DPEP1）途徑，並被Arch科學家及其合作者證明可以在臨床前模型中預防腎臟缺血再灌注損傷（視頻），爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現詳見《Science Advances》雜誌，標題爲“Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury”的Lau et. al.，以及該公司網站上有關DPEP1和LSALT肽的最新同行評議的出版物。LSALT肽是公司用於預防和治療腎臟、肺部和肝臟炎症損傷的主要藥物候選物。該藥物靶向二肽酶-1（DPEP1）途徑，並被Arch科學家及其合作者證明可以在臨床前模型中預防腎臟缺血再灌注損傷（視頻），爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現詳見《Science Advances》雜誌，標題爲“Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury”的Lau et. al.，以及該公司網站上有關DPEP1和LSALT肽的最新同行評議的出版物。LSALT肽是公司用於預防和治療腎臟、肺部和肝臟炎症損傷的主要藥物候選物。該藥物靶向二肽酶-1（DPEP1）途徑，並被Arch科學家及其合作者證明可以在臨床前模型中預防腎臟缺血再灌注損傷（視頻），爲Arch在這項CS-AKI試驗中使用LSALT肽提供了科學依據。他們的發現詳見《Science Advances》雜誌，標題爲“Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury”的Lau et. al.，以及該公司網站上有關DPEP1和LSALT肽的最新同行評議的出版物。
Incidence of CS-AKI
CS-AKI的發生率
Acute kidney injury 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.
急性腎損傷是冠狀動脈搭橋移植（CABG）和其他心臟手術，包括增加AKI風險的體外循環手術後的常見併發症。CS-AKI的報告患病率高達30％，並獨立與發病率和死亡率的增加有關。
About Arch Biopartners
關於Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing a platform of new drugs to prevent inflammation in the kidneys, liver and lungs via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem.
Arch Biopartners Inc.是一家專注於預防炎症和急性器官損傷的晚期臨床試驗公司。該公司正在開發一系列通過二肽酶-1（DPEP1）途徑防止腎臟、肝臟和肺部炎症的新藥物平台，並與許多常見損傷和疾病相關，其中器官炎症是一個未被滿足的問題。
For more information on Arch Biopartners' science and drug platform, please visit:
欲了解更多Arch Biopartners的科學和藥物平台信息，請訪問：
For investor information and other public documents the company has also filed on SEDAR+, please visit
欲了解有關Arch Biopartners的投資者信息和公司在SEDAR+上提交的其他公共文件，請訪問
The Company has 63,850,633 common shares outstanding.
公司擁有63,850,633股普通股。
Forward-Looking Statements
前瞻性聲明
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 .
本新聞發佈稿包含適用於加拿大證券法的前瞻性聲明，涉及我們未來業績、流動性和資本資源，以及我們針對二肽酶-1（DPEP-1）途徑靶向藥物候選品的臨床開發工作，包括與LSALT肽（Metablok）相關的臨床試驗結果、我們藥物候選品的成功商業化和營銷、我們是否將獲得以及獲得監管批准的時間和成本、我們籌集資本以資助我們業務計劃的能力、我們藥物候選品的功效與競爭對手開發的藥物候選品相比較的能力、我們保留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。這些聲明基於管理層的當前期望和信念，包括某些因素和假設，如我們最近的年度審計財務報表和相關管理討論及分析中所述的“業務風險和不確定性”部分所述。由於這些風險和不確定性，或其他未知的風險和不確定性，我們的實際結果可能與任何前瞻性聲明中包含的結果有所不同。這些詞語“相信”、“可能”、“計劃”、“將”、“估計”、“繼續”、“預計”和類似表達意思的詞語旨在識別前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別詞語。我們不承擔更新前瞻性聲明的義務，除非法律要求。關於Arch Biopartners Inc.的其他信息，包括我們最近的年度審計財務報表，可通過訪問加拿大證券管理機構的電子文件分析和檢索系統（“SEDAR”）網站獲得。
The science and medical contents of this release have been approved by the Company's Chief Science Officer
本發佈稿的科學和醫學內容已獲公司首席科學官批准
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
TSX Venture Exchange及其監管服務提供者（如TSX Venture Exchange的政策中所定義的）不接受對本發佈內容的充分性或準確性的責任。
CONTACT: For more information, please contact: Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
聯繫方式：欲了解更多信息，請聯繫Richard Muruve首席執行官Arch Biopartners，Inc. 647-428-7031 info@archbiopartners.com
譯文內容由第三人軟體翻譯。