The study represents the first ever-clinical application of Hemopure globally for ex situ warm machine perfusion of human donor livers
All 11 patients remain alive from six to 20 months post surgery
Oral presentations conducted at two prestigious conferences; findings have been submitted to an international peer review journal
SOUDERTON, Pa. and GRONINGEN, Netherlands, June 3, 2019 /PRNewswire/ -- Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), a world leader in oxygen-carrying solutions, announced that two abstracts related to Hemopure's clinical development program in liver transplantation, were recently presented in oral sessions at the International Liver Transplantation Society and European Surgical Association respectively, May 2019.
"Preliminary results demonstrate that machine perfusion technology using Hemopure, a novel synthetic oxygen carrying solution, safely increases the number of transplantable livers and with the added benefit of avoiding the need for human blood products," said the Principal Investigator, Professor Robert J. Porte, Chief of HPB Surgery and Liver Transplantation at University Medical Center Groningen, The Netherlands. "We are encouraged by the follow up survival data which has exceeded the study protocol and shows that all 11 patients remain alive with the longest being at 20 months post surgery," continued Professor Porte.
Worldwide, this is the first human study where donor livers considered unsuitable for transplantation were refurbished and tested in a perfusion machine, using Hemopure. Sixteen suboptimal donor livers that were initially rejected by all transplant centers in The Netherlands underwent machine perfusion at the leading liver transplant hospital, the University Medical Center in Groningen (UMCG). Following reconditioning and viability, 11 of the 16 donor livers (69 percent) were considered transplantable. These livers were subsequently successfully transplanted, resulting in 100 percent graft and patient survival rates.
"A key observation from this study is that machine perfusion combined with Hemopure has the potential to significantly expand the pool of initially declined high-risk donor livers," said Zafiris Zafirelis, CEO of HbO2 Therapeutics. "We are developing a substantial body of clinical and real-world evidence for the use of Hemopure in transplantation medicine and look forward to helping save many more patients for whom there are no other treatment options."
About Hemoglobin Oxygen Therapeutics LLC HbO2 Therapeutics is a clinical-stage biotechnology company developing a proprietary technology platform for oxygen-carrying solutions that increase the amount of oxygen transported throughout the body.
HbO2 Therapeutics two lead programs are Oxyglobin® [hemoglobin glutamer - 200 (bovine)] and Hemopure® [hemoglobin lutamer - 250 (bovine)] indicated for veterinary and human use, respectively.
Oxyglobin is the only oxygen-carrying solution approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to treat all cause canine anemia.
Hemopure is approved in South Africa to treat anemia in adult surgical patients. In the US, Hemopure is only available through the FDA expanded access program to qualifying patients for whom blood transfusion is not an option, and who have exhausted all other treatments. Blood transfusion may not be an option due to religious beliefs, or because no compatible blood is available for a patient needing a transfusion.
Hemopure is also under development for other uses, including as a perfusion solution for other organs prior to transplantation including liver and kidney.
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