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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

圣迈克尔医院加入针对心脏外科相关急性肾损伤的LSALT肽的II期试验
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.

多伦多,2024年4月16日(GLOBE NEWSWIRE)——Arch Biopartners Inc.(“Arch” 或 “公司”)(多伦多证券交易所风险投资公司:ARCH 和OTCQB:ACHFF)今天宣布,多伦多Unity Health所在地圣迈克尔医院的研究小组已加入针对预防和治疗心脏手术相关急性肾损伤(CS-AKI)的LSALT肽的二期试验。LSALT 肽是该公司预防和治疗肾脏、肺部和肝脏炎症损伤的主要候选药物。

"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.

“我们的研究团队很高兴能参与这项试验。器官损伤和修复是多伦多Unity Health的研究支柱,我们致力于研究组织损伤和愈合的关键机制,并开发减少损伤和增强再生的疗法。” 圣迈克尔医院转化研究员、麻醉师和重症监护医生戴维·马泽博士说。

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

在开始注册该试验之前,圣迈克尔医院的临床团队正在等待伦理批准。

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.

将圣迈克尔作为加拿大的第三个临床场所使试验地点的数量增加到九个,土耳其目前有六家医院正在招募患者。

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 期试验是一项国际多中心、随机、双盲、安慰剂对照的 LSALT 肽研究。该试验的招募目标是240名患者。该试验的主要目标是评估按KDIGO(肾脏疾病:改善全球预后)标准定义的体外(心肺机)心脏手术后七天内患有AKI的受试者的百分比。

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.

二期试验的详细信息,标题为”用于预防或减轻体外科患者急性肾损伤(AKI)的LSALT肽的2期全球、多中心、随机、双盲、安慰剂对照研究” 可以在 clinicaltrials.gov 上查看。

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

心脏手术相关急性肾损伤 (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 通常由缺血再灌注损伤 (IRI) 引起,导致血流减少(缺血),从而减少肾脏中的氧气,从而导致肾细胞损伤。一旦血流恢复正常(再灌注),就会引发炎症,加剧对肾细胞的损伤。在AKI的最坏情况下,肾脏衰竭,导致肾脏透析或肾脏移植。当今市场上没有治疗方法可以预防体外心脏手术患者常见的急性肾损伤。

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)途径,Arch科学家及其合作者在临床前模型(视频)中证明LSALT肽可以防止肾脏的IRI,这为Arch在这项CS-AKI试验中使用LSALT肽提供了科学依据。他们的发现细节发表在该杂志上, 《科学进展》,标题为”二肽酶-1 控制缺血再灌注损伤期间的肾脏炎症“由刘等人撰写,可以在该公司的网站上找到之前关于 DPEP-1 和 LSALT 肽的同行评审出版物。

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.

该公司于2023年3月宣布的加拿大国家研究委员会工业研究援助计划(NRC-IRAP)的咨询服务和拨款将大大抵消CS-AKI二期试验的成本。

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

心脏手术相关急性肾损伤 (CS-AKI) 的发病率

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.

急性肾损伤(AKI)是冠状动脉旁路移植术(CABG)和其他心脏手术(包括增加急性心肌梗死风险的体内手术)后患者的常见并发症。报告的CS-AKI患病率高达30%,与发病率和死亡率的增加独立相关。

About Arch Biopartners

关于 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. 是一家后期临床试验公司,专注于预防炎症和急性器官损伤。该公司正在开发新的候选药物,该药物可通过二肽酶-1(DPEP-1)途径抑制肺部、肾脏和肝脏的炎症,并与器官炎症尚未得到解决的常见损伤和疾病有关。

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

有关Arch Biopartners科学和技术的更多信息,请访问:

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

有关投资者信息以及该公司也在SEDAR+上提交的其他公开文件,请访问

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

该公司有62,855,633股已发行普通股。

Forward-Looking Statements

前瞻性陈述

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 .

本新闻稿包含适用的加拿大证券法所指的前瞻性陈述,内容涉及我们对未来业绩、流动性和资本资源的预期,以及针对二肽酶-1(DPEP-1)途径的候选药物的持续临床开发,包括我们与LSALT肽(Metablok)相关的临床试验结果、候选药物的成功商业化和上市、我们是否会获得监管部门批准的时间和成本加拿大、美国各州、欧洲和其他国家、我们筹集资金为商业计划提供资金的能力、我们的候选药物与竞争对手开发的候选药物相比的疗效、我们留住和吸引关键管理人员的能力,以及我们知识产权组合的广度和保护能力。这些报表基于管理层当前的预期和信念,包括某些因素和假设,如我们最新的年度经审计的财务报表以及在 “业务风险和不确定性” 标题下的相关管理讨论和分析中所述。由于这些风险和不确定性或其他未知风险和不确定性,我们的实际业绩可能与任何前瞻性陈述中包含的结果存在重大差异。“相信”、“可能”、“计划”、“将”、“估计”、“继续”、“预期”、“打算”、“期望” 等词语旨在识别前瞻性陈述,尽管并非所有前瞻性陈述都包含这些识别性词语。除非法律要求,否则我们没有义务更新前瞻性陈述。有关Arch Biopartners Inc. 的其他信息,包括我们最新的年度经审计的财务报表,可访问加拿大证券管理局电子文件分析和检索系统(“SEDAR”)网站,网址为。

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

本新闻稿的科学和医学内容已获得公司首席科学官的批准

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

多伦多证券交易所风险交易所及其监管服务提供商(该术语在多伦多证券交易所风险交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任

CONTACT: For more information, please contact:   Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
联系人:欲了解更多信息,请联系:理查德·穆鲁夫首席执行官 Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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