- Study demonstrated safety and tolerability
of H-Guard® to address serious immune system-driven
complications of dialysis
- Encouraging biomarker data positions H-Guard® for
upcoming Acute Kidney Injury trial
GLASGOW,
Scotland, May 23, 2024 /PRNewswire/ -- Invizius
Limited ("Invizius"), a biotechnology company developing
breakthrough treatments for patients on dialysis, announces that
eight patients have been successfully treated at the National
Institute for Health and Care Research (NIHR) Manchester Clinical
Research Facility (CRF) with H-Guard® Priming Solution in its
first-in-human Phase 1 clinical study.
The study was conducted at the NIHR Manchester CRF at the
Manchester Royal Infirmary (MRI), part of the Manchester University
NHS Foundation Trust, led by Professor Sandip Mitra and co-investigators, Dr
Leonard Ebah and Dr Duha Ilyas.
The study investigated the safety of H-Guard® in patients
undergoing haemodialysis who are vulnerable to dialysis-induced
immune activation. H-Guard® is flushed through the dialysis
machine, coating all blood exposed surfaces prior to treatment.
Patients received a single treatment of H-Guard® with pre and
post treatment evaluations demonstrating its safety and
tolerability.
The next stage is the Phase2b study for Acute Kidney Injury
(AKI) where the Continuous Renal Replacement Therapy (CRRT) filter
in an Intensive Care Unit (ICU) is coated with H-Guard®.
Dr Magnus Nicolson, CEO of
Invizius, said: "It has been a pleasure to work with Professor
Mitra and his team to demonstrate the safety of H-Guard® on
dialysis patients. This is an important milestone for H-Guard® and
Invizius, allowing us to progress into a larger efficacy study
showing the clinical benefits of controlling complement activation
in CRRT and a number of extracorporeal systems."
Professor Sandip Mitra,
Consultant Nephrologist and Professor of Renal Medicine at
Manchester University NHS Foundation
Trust, commented: "As our aim is to improve the
outcomes of patients on dialysis, we are very encouraged by the
results of the H-Guard® trial. This week at the ERA in
Stockholm, Dr Ilyas Duha will be presenting data from Invizius
sponsored trial CompAct-HD. This is the largest kinetic analysis of
complement activation in routine haemodialysis (HD) ever undertaken
in UK. Our results indicate patient specific complement activation
associated with inflammatory response during routine haemodialysis.
Reduction in complement activation in HD may yield significant
clinical outcome benefits."
H-Guard® is a potent anti-inflammatory and anti-coagulatory,
second generation, complement regulator which coats the dialysis
filter and tubing during the priming process.
Invizius managed the trial with TCRSolutions.
Photo:
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House
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+44 (0)7813 193618
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