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University Of Calgary Joins The Phase II Trial Of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
TORONTO, March 15, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced today that a research team from the University of Calgary's Cumming School of Medicine 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.
"We know that acute kidney injury impairs recovery and can negatively affect long-term outcomes following heart surgery. Our research team is excited to participate in a study working towards improving kidney health in our patients." said Alex Gregory MD, Assistant Professor and Director of Research, Division of Cardiovascular Anesthesia at the Libin Cardiovascular Institute at the Cumming School of Medicine, and site principal investigator for the LSALT Phase II CS-AKI trial.
Dr. Gregory's clinical team has submitted an application to the local Research Ethics Board for permission to participate in the trial.
The addition of the first Canadian clinical site increases the number of trial sites to four, with three hospitals in Turkey currently recruiting patients. There are three additional hospital sites in Turkey pending activation into the trial. The Arch Biopartners team is currently working with two other hospital sites in Canada to prepare for their participation in this Phase II trial.
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.
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.
Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide
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 treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.
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.
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.
Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI)
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.
About Arch Biopartners
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.
For more information on Arch Biopartners' science and technologies, please visit: www.Archbiopartners.Com/our-science
For investor information and other public documents the company has also filed on SEDAR+, please visit www.Archbiopartners.Com/investor-hub
The Company has 62,755,633 common shares outstanding.
Forward-Looking Statements
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 www.Sedarplus.Ca .
The science and medical contents of this release have been approved by the Company's Chief Science Officer
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
Medical Conditions You Must Report To DVLA Amid Potential Changes
A car expert said that DVLA decisions about medical conditions affect nearly 900,000 drivers every year - and potential changes to criteria could alter that. Darren Miller from BigWantsYourCar.Com said there was a "significant impact" of the DVLA decisions regarding medical conditions.
He said: "The DVLA's decisions on medical conditions and driving are crucial for ensuring road safety. With nearly 900,000 medical licensing decisions made in a year, it's evident that a significant number of drivers are affected.
"The requirement for drivers to surrender their licence to the DVLA if their condition affects their driving for three months or more is crucial for safety. The DVLA may issue a new shorter-term licence, or recommend special adaptations to the vehicle to accommodate specific needs from the individual's medical condition.
"The DVLA's guidelines require drivers to report any changes in their health that could impact their ability to drive safely. These decisions not only safeguard individual drivers, but also contribute to overall road safety, minimising the risk of accidents caused by medical issues."
People affected by DVLA medical decisionsDarren said: "Anyone with a driving licence who experiences a 'notifiable' medical condition or disability is directly affected by DVLA decisions. This includes individuals with conditions such as diabetes, heart conditions, epilepsy and more.
"The DVLA's assessments ensure that drivers with medical conditions are fit to drive and take appropriate measures to maintain safety on the roads. It's a responsibility shared by both drivers and regulatory agencies to prioritise safety above all else."
Potential changes in DVLA policiesDarren said: "Potential changes in DVLA policies could involve adjustments to the renewal process or stricter guidelines for reporting medical conditions. While the current system mandates reporting at age 70, there may be discussions around lowering this age threshold to 65, as suggested by recent petitions.
"Such changes could lead to more frequent assessments of older drivers' fitness to drive, ensuring that they meet the necessary standards for road safety. However, any alterations must balance safety concerns with the practical needs of drivers."
Medical conditions you may need to report to the DVLAArch Biopartners Announces Univ Of Calgary Joins With Phase II Trial Of LSALT Peptide To Treat Cardiac Surgery-associated Acute Kidney Injury
Arch Biopartners Inc, a late-stage clinical trial company focused on preventing inflammation and acute organ injury, has announced that a research team from the University of Calgary's Cumming School of Medicine 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.
"We know that acute kidney injury impairs recovery and can negatively affect long-term outcomes following heart surgery. Our research team is excited to participate in a study working towards improving kidney health in our patients." said Alex Gregory MD, Assistant Professor and Director of Research, Division of Cardiovascular Anesthesia at the Libin Cardiovascular Institute at the Cumming School of Medicine, and site principal investigator for the LSALT Phase II CS-AKI trial.
Dr. Gregory's clinical team has submitted an application to the local Research Ethics Board for permission to participate in the trial.
The addition of the first Canadian clinical site increases the number of trial sites to four, with three hospitals in Turkey currently recruiting patients. There are three additional hospital sites in Turkey pending activation into the trial. The Arch Biopartners team is currently working with two other hospital sites in Canada to prepare for their participation in this phase II trial.
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 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 treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.
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 acute kidney injury. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality.
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