HbO

Hemoglobin Oxygen Therapeutics LLC

Hemoglobin Oxygen Therapeutics LLC Announces Multiple Presentations Using Hemopure® in Donor Livers Previously Rejected for Transplant.

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 Netherlandsunderwent 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.

Contact Details
Sunny Uberoi
Chief Communications Officer
917.747.2018  
suberoi@hbo2therapeutics.com

LINKS ON PUBLICATION
https://www.prnewswire.com/news-releases/hemoglobin-oxygen-therapeutics-llc-announces-multiple-presentations-using-hemopure-in-donor-livers-previously-rejected-for-transplant-300860404.html?tc=eml_cleartime

Anti-N and anti-Do(a) immunoglobulin G alloantibody-mediated delayed hemolytic transfusion reaction with hyperhemolysis in sickle cell disease treated with eculizumab and HBOC-201: case report and review of the literature.

Unnikrishnan A, Pelletier JPR, Bari S, Zumberg M, Shahmohamadi A, Spiess BD, Michael MJ, Harris N, Harrell D, Mandernach MW. Transfusion. 2019 Feb 15. doi: 10.1111/trf.15198. [Epub ahead of print] PubMed PMID: 30768787.

Hemopure Plays A Pivotal Role in A Pioneering Study Published in Nature

Researchers from Yale School of Medicine Demonstrated Restored Cellular Functions In Pig Brains After Death Using Hemopure.

Hemopure May Become a Novel, Broadly Applicable and Easy-to-Handle Perfusion Solution For Multiple Organs.

SOUDERTON, Pa., April 18, 2019 /PRNewswire/ — Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), a world leader in oxygen-carrying solutions, today announces pioneering research conducted at Yale School of Medicine highlighting an innovative system that restores brain circulation and some cellular functions in pig brains four hours after death. Importantly, there was no evidence of global network activity or full-brain function such as awareness, perception or other higher-order brain functions during the experiments.

Published as the lead study in the April 2019 issue of Nature, the system called BrainExinvolves three components including engineering a specific perfusion solution using Hemopure as a critical ingredient to supply oxygen to the tissue. BrainExis designed to mimic pulsating blood flow (perfusion) at normal body temperature (37 degrees Celsius), and during a six-hour perfusion period, the researchers observed a reduction in cell death and evidence for the restoration of some cellular functions, including spontaneous synaptic activity.

The findings from the study entitled “Restoration of Brain Circulation and Cellular Function Hours Postmortem” indicate that the brain possesses a higher capacity for cellular restoration than was previously observed and that deterioration after cessation of blood flow may be a prolonged rather than rapid process. The researchers stated that further experiments with more extended perfusion periods are needed before broader applications of this system could be considered such as gaining new insights into brain disorders including stroke and Alzheimer’s disease.

“We have spent six years diligently building the BrainExtechnology platform, and HbO2Therapeutics has been a partner for four of those years” said the Principal Investigator, Nenad Sestan, MD, PhD, Professor of Neuroscience, Comparative Medicine, Genetics and Psychiatry at the Yale School of Medicine. “A critical success factor is the ability to keep cerebral tissue viable, and Hemopure proved to be an essential ingredient in transferring and mobilizing oxygen to the brain.  We look forward to HbO2Therapeutics continued support as we explore longer perfusion studies to better understand the dynamics of cellular recovery following prolonged global ischemia,”continued Professor Sestan.

“We are honored to be supporting this pioneering research, challenging the notion that widespread cell dell death is unavoidable, minutes or even hours after blood flow stops”, said Zafiris Zafirelis, CEO of HbO2Therapeutics. “These results further validate recent preclinical and clinical data demonstrating the ability of Hemopure to perfuse organs such as kidney and liver showing that Hemopure could potentially replace packed red blood cells in organ transplantation.”

About Hemoglobin Oxygen Therapeutics LLC   

HbO2Therapeutics 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.

HbO2Therapeutics two lead programs 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 other organs prior to transplantation including liver and kidney.

For more information, please visit www.hbo2therapeutics.com

Contact Details:
Sunny Uberoi
Chief Communications Officer
917.747.2018
suberoi@hbo2therapeutics.com

Hemoglobin Oxygen Therapeutics LLC Announces Preclinical Results on Hemopure in Kidneys Discarded for Human Transplantation

Massachusetts General Hospital Study Suggest that Hemopure is an Acceptable Alternative for Human Blood Products in Kidneys Undergoing Machine Perfusion Technology.

Study Published in The American Journal of Transplantation.

SOUDERTON, PA, April 9, 2019 /PRNewswire/ — Hemoglobin Oxygen Therapeutics LLC ( HbO2Therapeutics), 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 HbO2Therapeutics. “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.

 

About Hemoglobin Oxygen Therapeutics LLC   

HbO2Therapeutics 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.

HbO2Therapeutics 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 Details
Sunny Uberoi
Chief Communications Officer
917.747.2018
suberoi@hbo2therapeutics.com

 

Hemoglobin Oxygen Therapeutics LLC Announce Updated Results From The Netherlands Leading Liver Transplant Hospital

Pilot study shows ten donor livers previously rejected for transplant, salvaged with new machine perfusion technology using Company’s lead product, Hemopure®.

To date, results show 100 percent transplant and survival rates for all patients.

SOUDERTON, PA and GRONINGEN, The Netherlands. February 13 2019 —  Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics), a biopharmaceutical company specializing in oxygen therapeutics, today announced results from a pilot study on liver transplants conducted at the Netherlands largest transplantation center, the University Medical Center in Groningen (UMCG) under the direction of the lead investigator Professor Robert Porte, Head of Hepatobiliary Surgery and Liver Transplantation.

The study involved donor livers that were deemed unsuitable for regular transplantation. These organs were subjected to an innovative machine perfusion technology (a simulation of how the liver works in the body) using Hemopure, a novel synthetic oxygen solution that increases the oxygen-carrying capacity of blood. Given the solution’s ability to safely transport oxygen from much colder temperatures to body heat, initially rejected livers appear more likely to respond positively, becoming suitable for transplantation.

The results showed that 16 livers that were initially rejected by all transplant centers in The Netherlands, including UMCG, underwent machine perfusion to assess the organ’s viability at 37°C. Following viability testing including the ability to produce bile, ten donor livers were successfully reconditioned using Hemopure solution. A further benefit of applying this solution included the avoidance of any blood products during the perfusion process. HbO2 Therapeutics is pleased to announce 100% transplant and survival rates in the study including those patients receiving “refurbished” livers treated with Hemopure.

“We are thrilled to be collaborating with UMCG given that this is the first of its kind study with important variables tested in real time including individual liver differences, overall liver viability, and Hemopure perfusion,” said Zafiris Zafirelis, CEO of HbO2 Therapeutics. “The United Network for Organ Sharing (UNOS) estimates that over 13,700 people are currently waiting for a liver transplant nationwide, yet only about 8,250 transplants performed in 2018. Given the significant need to increase donor transplants, the key takeaway from this pilot study indicates that discarded donor livers could be refurbished with the help of Hemopure.”

 

Record number of liver transplants at UMCG due to new perfusion technique

​​In 2018, the UMCG carried out 73 liver transplants. On average around 60 liver transplants were done in the past few years, and in 2017 there were 56. This increase of around 20 percent is almost completely due to the use of normothermic machine preservation of donor livers that were rejected for transplantation in the first instance. With this innovative technique developed at the UMCG, more donor livers can be made suitable for transplantation. The results of the transplants made possible by this technique have been very good so far. So far, there is a 100 percent transplant and patient survival rate.

In this technique developed at the UMCG, donor livers of an initially insufficient quality are ‘refurbished’ in a perfusion machine. The donor livers are rinsed with a special, cold oxygen-enriched liquid before being gradually heated to a temperature of 37 degrees, to bring them ‘back to life’. It can then be tested whether the acidity of the donor livers has returned to normal and whether the livers have begun producing bile again. Once they have been thoroughly tested outside the body, the livers can be successfully transplanted into the patients.

The UMCG has developed this special perfusion solution with a synthetic oxygen carrier that enables donor livers to be heated on the perfusion machine before being tested. In the development phase, the UMCG collaborated with HbO2 Therapeutics from the US. Thanks to the solution, donor blood is no longer needed to perfuse the donor organ. In addition to nutrients, the solution contains a special protein (Hemopure) that can transport oxygen both at low temperatures and at body temperature.

The results of the first transplants using initially rejected livers that were ‘refurbished’ by machine perfusion were published in the leading journal American Journal of Transplantation​ at the end of December 2018.

The National Institute for Health and Care Excellence (NICE) approves organ perfusion for use on the NHS, stating that perfusion machines could increase the number of livers that can be safely used for transplantation

A new procedure for storing livers donated for transplant has been hailed a “game changer” and approved for use on the NHS.

The National Institute for Health and Care Excellence (NICE) say perfusion machines could increase the number of livers that can be safely used for transplantation.

They store donated livers at body temperature, which slows the deterioration of the organ.

Usually donor livers are kept on ice.

This can cause damage to the liver and limit how long it can be stored.

About 20% of patients die while waiting for a liver transplant and about a third of donated livers are unable to be used for transplantation.

These could include livers taken from elderly people or those in poor health and those damaged while the organ was removed from the donor’s body or while being kept in ice.

The perfusion machine allows the liver to recover from any damage and it can be flushed with blood at body temperature and given oxygen, medications and nutrients allowing its viability and function to be assessed.

This could mean that livers that might have previously been considered unsuitable can be used safely.

The machines can also extend how long the liver can be stored to allow more flexibility in the timing of the transplant operation.

Prof Kevin Harris, at NICE, said: “It offers another way of preserving the liver and assessing whether livers which might have previously been considered unsuitable can be used safely.

“By using this procedure, more patients on the organ transplant waiting list could be offered a chance of a transplant and thereby potentially extending their lives.”

Darius Mirza, professor of transplant surgery at University Hospitals Birmingham, said the machine was a “game changer”.

“In the 30 years I’ve been involved with transplantation, there have been three or four events which have been game changers and I’m absolutely certain we are looking at a game changer that will change the way we practise organ storage and transplantation.”

Liver perfusion is currently performed on the NHS in a small number of specialist centres in the UK.