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SOUDERTON, Pa., April 9, 2019 /PRNewswire/ -- Hemoglobin Oxygen Therapeutics LLC ( HbO2 Therapeutics), a biopharmaceutical company specializing in oxygen therapeutics, today announces the publication of preclinical data demonstrating that Hemopure could replace packed red blood cells (PRBCs) in normothermic kidney perfusion (NMP) - a novel platform which is gaining significant interest in the field of organ transplantation. This technology assesses the organ's viability before transplantation and requires a perfusion solution to provide adequate oxygen supply to the organ.
The results were published in the prestigious American Journal of Transplantation and involved 14 human kidneys obtained from the New England Donor Services (NEDS) after being declined for transplantation by all centers. These kidneys were perfused with either Hemopure (n=7) or packed red blood cells (n=7) to increase oxygen carrying capacity. The study evaluated renal artery resistance, oxygen extraction, metabolic activity, energy stores, production of urine and histological features.
The results showed that Hemopure performed comparably to packed red blood cells while overcoming logistical and clinical issues associated with red blood cell-based solutions including longer shelf half-lives, ease of use and accessibility, and negligible infectious risks.
"At Massachusetts General Hospital, 973 patients are awaiting kidney transplants as of the end of June 2018, an increase of 134 patients from the previous year," commented Dr. James F. Markmann, Chief of Transplant Surgery at Massachusetts General Hospital and Lead Investigator of the study. "Given the expanding gap between supply and demand for suitable kidney donors, there is growing interest in assessing and refurbishing discarded kidneys, and this feasibility study demonstrates that Hemopure can offer a logistically more convenient off-the-shelf alternative to packed red blood cells in machine perfusion technology."
"We are now witnessing the emergence of preclinical and clinical data supporting the use of Hemopure across donor organs," said Zafiris Zafirelis, CEO of HbO2 Therapeutics. "We are actively engaging leading investigators around the world, and look forward to advancing an important unmet medical need to increase the supply of organs."
Kidney Organ Donation and Transplantation Statistics
HbO2 Therapeutics two lead products are Oxyglobin® [hemoglobin glutamer - 200 (bovine)] and Hemopure® [hemoglobin glutamer - 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 organs prior to transplantation. In February 2019, HbO2 Therapeutics announced results from a pilot study on liver transplants conducted at the Netherlands largest transplantation center, the University Medical Center in Groningen (UMCG).
The results showed that ten donor livers were successfully reconditioned using Hemopure and resulted in transplant and survival rates of 100%. For more information, please visit www.hbo2therapeutics.com.
Contact DetailsSunny UberoiChief Communications Officer917.747.2018 [email protected]
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The results were published in the prestigious American Journal of Transplantation and involved 14 human kidneys obtained from the New England Donor Services (NEDS) after being declined for transplantation by all centers. These kidneys were perfused with either Hemopure (n=7) or packed red blood cells (n=7) to increase oxygen carrying capacity. The study evaluated renal artery resistance, oxygen extraction, metabolic activity, energy stores, production of urine and histological features.
The results showed that Hemopure performed comparably to packed red blood cells while overcoming logistical and clinical issues associated with red blood cell-based solutions including longer shelf half-lives, ease of use and accessibility, and negligible infectious risks.
"At Massachusetts General Hospital, 973 patients are awaiting kidney transplants as of the end of June 2018, an increase of 134 patients from the previous year," commented Dr. James F. Markmann, Chief of Transplant Surgery at Massachusetts General Hospital and Lead Investigator of the study. "Given the expanding gap between supply and demand for suitable kidney donors, there is growing interest in assessing and refurbishing discarded kidneys, and this feasibility study demonstrates that Hemopure can offer a logistically more convenient off-the-shelf alternative to packed red blood cells in machine perfusion technology."
"We are now witnessing the emergence of preclinical and clinical data supporting the use of Hemopure across donor organs," said Zafiris Zafirelis, CEO of HbO2 Therapeutics. "We are actively engaging leading investigators around the world, and look forward to advancing an important unmet medical need to increase the supply of organs."
Kidney Organ Donation and Transplantation Statistics
- The United Network for Organ Sharing (UNOS) estimates that over 103,000 people are currently waiting for a kidney transplant in the US, and yet only about 21,167 transplants performed in 2018.
- UNOS provided real-time data and based on organ type, kidney transplantation is ranked the highest at almost 59% of all transplants performed between 1998-2019.
- According to the National Kidney Foundation (NKF), on average, 3,000 new patients are added to the kidney waiting list each month while 13 people die each day waiting for a kidney transplant.
- The NFK estimates the median wait time for an individual's first kidney transplant is 3.6 years and can vary depending on health, compatibility, and availability of organs.
HbO2 Therapeutics two lead products are Oxyglobin® [hemoglobin glutamer - 200 (bovine)] and Hemopure® [hemoglobin glutamer - 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 organs prior to transplantation. In February 2019, HbO2 Therapeutics announced results from a pilot study on liver transplants conducted at the Netherlands largest transplantation center, the University Medical Center in Groningen (UMCG).
The results showed that ten donor livers were successfully reconditioned using Hemopure and resulted in transplant and survival rates of 100%. For more information, please visit www.hbo2therapeutics.com.
Contact DetailsSunny UberoiChief Communications Officer917.747.2018 [email protected]
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SOURCE Hemoglobin Oxygen Therapeutics
