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- First patient successfully completes dosing at Toronto General Hospital
- St. Michael’s Hospital is expected to be the next Canadian clinical site activated
- Arch is looking for additional clinical sites in North America to join the trial
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TORONTO, Aug. 06, 2025 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the University Health Network (UHN), Canada’s largest academic health sciences centre and a global leader in cardiac care and research. The volunteer patient completed five days of dosing as part of the Company’s ongoing Phase II trial evaluating LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI).
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Toronto General Hospital, ranked as the #3 hospital in the world and Canada’s top-ranked hospital by Newsweek in its 2025 list of the World’s Best Hospitals, is the first clinical site in Ontario to dose a patient in this trial. TGH joins the University of Calgary Hospital as the second Canadian clinical site to dose patients in this trial.
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The Company anticipates St. Michael’s Hospital (SMH) in Toronto will be the next Canadian site to activate and enroll patients into the study, pending approvals from Clinical Trials Ontario and SMH’s ethics board.
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The Arch team continues to pursue additional clinical sites in Canada and the United States. Patient recruitment in Turkey is being limited to diversify the demographic and geographic patient data produced by the trial.
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Quote from Richard Muruve, CEO, Arch Biopartners:
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“The start of dosing at Toronto General Hospital marks an important milestone in advancing Arch’s Phase II CS-AKI trial. The goal is to recruit about half of the trial’s patients in North America. Patient dosing completed in Turkey has provided a strong safety profile for LSALT peptide. This has given clinical trial teams increased confidence as new sites join the trial to test LSALT peptide’s ability to protect kidneys from acute inflammation injury.”
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About the CS-AKI Phase II Trial
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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. Subjects are randomized to receive either LSALT peptide (10 mg IV twice daily for five days) or placebo, consistent with previous clinical and dose-escalation trials. 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, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
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The start of the Phase II CS-AKI trial and the ongoing dosing of volunteer patients has been mainly supported through non-dilutive funding grants previously disclosed by the Company.
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The Company will update the study’s listing on ClinicalTrials.gov following today’s news regarding recruitment at Toronto General Hospital including a revised estimated trial completion date of August 2026. This update reflects the 12 to 18 months required by Canadian sites to complete preparations and obtain provincial and local ethics approvals prior to enrolling patients.
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