LAKEWOOD, Colo., U.S., and SANTA ROSA, Calif., U.S. – Acute kidney injury (AKI) and sepsis-induced acute kidney injury (S-AKI) are life-threatening conditions, with many patients dying and others left with long-term kidney damage requiring lifelong dialysis and resulting in early death.
Terumo Blood and Cell Technologies (Terumo), a medical technology company, and Eliaz Therapeutics Inc. (ETI), a medical device company, today announced an exclusive collaboration to help combat AKI and S-AKI by focusing on the selective removal of an upstream inflammatory protein called Galectin-3 (Gal-3) from blood plasma.
The in-hospital mortality rate for patients with AKI has been estimated at 20% to 25%,1 while critically ill patients with dialysis-requiring AKI have mortality rates exceeding 50%.2 Patients who survive an episode of AKI face a lifelong increased risk of chronic kidney disease (CKD), end-stage renal disease (ESRD), cardiovascular events and reduced quality of life. Treatment for AKI/S-AKI is primarily supportive as no therapeutic modalities have shown efficacy.3
Terumo and ETI will initially conduct studies on large animals followed by human clinical trials. Large animal studies are scheduled to start later this year. The collaboration will use Terumo's Spectra Optia® Apheresis System with ETI's novel XGal-3® column that is designed to selectively remove Gal-3 from blood plasma. XGal-3 is being developed as a platform technology. XGal-3 will be initially tested in AKI and S-AKI.
Terumo Blood and Cell Technologies specializes in a portfolio of technology, software and services for blood component collection, therapeutic apheresis and cellular technologies. The company has other collaborations that use its Spectra Optia system with other columns that are designed for triple-negative breast cancer and COVID-19. The company focuses on innovation and development and spends three times the industry average on this part of the business.
"Over 13 million people globally are affected by AKI, with nearly 2 million lives lost every year.4 This collaboration leverages the widely available Spectra Optia platform to bring the XGal-3 treatment to patients worldwide," says Veerle d'Haenens, General Manager, Therapeutic Systems, Terumo Blood and Cell Technologies.
In the U.S. alone, AKI and S-AKI affect 4 million people with annual healthcare costs of up to $24 billion USD. Patients who require dialysis face reduced quality of life, while each hospitalization can incur bills totaling $42,000 per incident.5 Current therapeutic options are limited.
"This collaboration will enable us to support the advancement of the XGal-3 device," says Isaac Eliaz, MD, founder and chief executive officer of ETI. "The XGal-3 column device is designed to improve health outcomes for critically ill patients and reduce the incidence of chronic kidney disease and hospital mortality, while potentially reducing the need for dialysis and shortening intensive care stays. Working with Terumo Blood and Cell Technologies could bring broad availability of this therapy to the global marketplace."
ETI recently received its second grant from the National Institutes of Health (NIH). The SBIR-II $1.7 million USD grant will focus on large animal safety studies of the XGal-3 column device, allowing ETI to proceed with clinical trials in sepsis and S-AKI patients. ETI will use Terumo's Spectra Optia in both the large animal studies and human clinical trials. ETI plans to report results from the human clinical trial in approximately three years.
Gal-3 is postulated to be a mediator and driver of inflammation in a wide range of acute and chronic conditions. Increased plasma Gal-3 levels are associated with more severe AKI and sepsis development in critically ill patients.6 In turn, blocking of Gal-3 has significantly decreased AKI rates and increased survival in animal models.7
1Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3):457-467. doi:10.1038/ki.2013.153/
2Selby, NM, Kolhe, NV, McIntyre CW, et al. Defining the cause of death in hospitalised patients with Acute Kidney Injury. PLOS ONE. Published November 2, 2012. doi: 10.1371/journal.pone.0048580
3Paweena S, Cruz DN, Cerda J, et al. World incidence of AKI: a meta-analysis. CJASN. 2013;8(9):1482-1493. doi: 10.2215/CJN.00710113
4Mehta RL, Cerdá J, Burdmann EA, et al. International Society of Nephrology's 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015; 385:2616-2643. doi: 10.1016/S0140-6736(15)60126-X
5Silver SA, Chertow GM. The economic consequences of acute kidney injury. Nephron. 2017;137(4):297-301. doi:10.1159/000475607
6Boutin L, Legrand M, Sadoune M, et al. Elevated plasma Galectin-3 is associated with major adverse kidney events and death after ICU admission. Crit Care. 2022;26:13. doi: 10.1186/s13054-021-03878-x
7Sun H, Jiang H, Eliaz A, Kellum JA, Peng Z, Eliaz I. Galectin-3 in septic acute kidney injury: a translational study. Crit Care. 2021;25(1):109. 2021;25:109. doi:10.1186/s13054-021-03538-0
About Eliaz Therapeutics
Eliaz Therapeutics Inc., based in Santa Rosa, California (www.EliazTherapeutics.com), a privately held medical device company, is a pioneer in the groundbreaking development of a patent-protected therapeutic apheresis device (XGAL-3®), which effectively removes Galectin-3 from blood plasma and seamlessly integrates with existing apheresis machines. The initial focus of ETI is sepsis and acute kidney injury (AKI). At a later stage the company expects to pursue additional indications such as chronic kidney disease, nonalcoholic steatohepatitis and cancer. ETI has developed a multi-tiered global IP portfolio and demonstrated the ability of its Gal-3-specific apheresis to reduce the inflammatory response in animal models.
About the Spectra Optia® Apheresis System
The Spectra Optia system is a user-friendly, versatile, industry-leading therapeutic apheresis and cell collection platform that allows operators to spend more time focusing on patient care. Therapeutic apheresis is used widely for a variety of therapies. For example, practitioners use red blood cell exchange (RBCX) for sickle cell disease treatment; cell collections for stem cell transplantations and to collect starting material for cell therapies; and therapeutic plasma exchange (TPE) to treat many diseases in both the chronic and acute setting in the neurology, nephrology and hematology spaces. Product and protocol availability varies by country.
About Terumo Blood and Cell Technologies
Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees around the world believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers.
Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 130 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.
We have global headquarters in Lakewood, Colo., U.S.A., along with five regional headquarters, seven manufacturing sites and six innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.