THE USE OF PEGYLATED CARBOXYHEMOGLOBIN BOVINE IN PATIENTS FOR WHOM BLOOD IS NOT AN OPTION
(Abstract release date: 05/19/16)
EHA Library. Jubin R. 06/12/16; 135328; S834
Dr. Ronald Jubin
Contributions
Contributions
Abstract
Abstract: S834
Type: Oral Presentation
Presentation during EHA21: On Sunday, June 12, 2016 from 08:15 - 08:30
Location: Room H6
Background
Severe hypoxia due to low hemoglobin (Hb) levels causes significant morbidity and mortality. This is of great concern for patients who cannot receive blood transfusions due to personal (i.e., Jehovah’s Witness) or medical (i.e., hyperhemolysis) reasons, or simply due to the lack of availability. PEGylated-carboxyhemoglobin (PEG-HbCO; SANGUINATE™) is a novel therapeutic agent designed to release carbon monoxide to reduce vascular inflammation and then transfer oxygen to hypoxic tissue and cells. PEG-HbCO has been used in 24 patients under the USA emergency Investigational New Drug (eIND) program. A retrospective analysis of these patients was performed.
Aims
Perform post-hoc analysis of clinical findings; their relationship to individual patient diagnosis/associated comorbidities and PEG-HbCO intervention.
Methods
23 patients with hemoglobin levels under 5 g/dL and 1 sickle cell disease patient with Hb of 8.7 were determined to be near death or at serious risk of severe morbidity and were treated with PEG-HbCO. Applications included AML, sickle cell disease (SCD) comorbidities, trauma and hemorrhagic shock. Patients ranged in age from 19 to 61. A unit of PEG-HbCO consists of 500 mL (40 mg/mL). Total doses ranged from 1 unit up to 8 units given over 9 days.
Results
No serious adverse events associated with PEG-HbCO were reported. All patients provided with timely emergency treatment with PEG-HbCO were reported by the investigator to show clear signs of improved mental function that was temporally associated with infusion of PEG-HbCO despite continuing low Hb levels. Improvements in cerebrovascular oximetry, cerebral blood flow, pulmonary infiltrates, renal function and serum biochemistry (bilirubin, liver function, LDH) were reported in various patients. A SCD patient with acute chest syndrome showed clearing of pulmonary infiltrate within 24 hours of PEG-HbCO infusion. Nine of eleven (81%) severely anemic patients showed improvement upon administration of PEG-HbCO, defined by an initial improvement in mental alertness and culminating in hospital discharge (excluding trauma patients with ISS score ≥25).
Conclusion
The varied results seen in these critical care patients represent preliminary evidence of substantial improvement in clinically significant endpoints used by the clinicians to assess response to treatment in the urgent care setting. Most important is the evidence of response despite no immediate improvement in the hemoglobin level which, if left untreated, may have lead many of these patients to significant morbidity and potential mortality. While severe anemia persisted for most of these patients, it appears that the life-threatening hypoxia did not. There is a significant unmet medical need to treat hypoxia in patients for whom blood is not an option. PEG-HbCO is under development for the treatment of the life-threatening effects of acute severe anemia (Hb ≤ 5 g/dL) in patients who cannot receive red blood cell transfusions. PEG-HbCO is also in clinical development for the treatment of SCD comorbidities, delayed graft function following renal transplantation and reduction of delayed cerebral ischemia following subarachnoid hemorrhage.
Session topic: Transfusion Medicine
Keyword(s): Bleeding, Blood transfusion, Hemoglobin, Hemolytic anemia
Type: Oral Presentation
Presentation during EHA21: On Sunday, June 12, 2016 from 08:15 - 08:30
Location: Room H6
Background
Severe hypoxia due to low hemoglobin (Hb) levels causes significant morbidity and mortality. This is of great concern for patients who cannot receive blood transfusions due to personal (i.e., Jehovah’s Witness) or medical (i.e., hyperhemolysis) reasons, or simply due to the lack of availability. PEGylated-carboxyhemoglobin (PEG-HbCO; SANGUINATE™) is a novel therapeutic agent designed to release carbon monoxide to reduce vascular inflammation and then transfer oxygen to hypoxic tissue and cells. PEG-HbCO has been used in 24 patients under the USA emergency Investigational New Drug (eIND) program. A retrospective analysis of these patients was performed.
Aims
Perform post-hoc analysis of clinical findings; their relationship to individual patient diagnosis/associated comorbidities and PEG-HbCO intervention.
Methods
23 patients with hemoglobin levels under 5 g/dL and 1 sickle cell disease patient with Hb of 8.7 were determined to be near death or at serious risk of severe morbidity and were treated with PEG-HbCO. Applications included AML, sickle cell disease (SCD) comorbidities, trauma and hemorrhagic shock. Patients ranged in age from 19 to 61. A unit of PEG-HbCO consists of 500 mL (40 mg/mL). Total doses ranged from 1 unit up to 8 units given over 9 days.
Results
No serious adverse events associated with PEG-HbCO were reported. All patients provided with timely emergency treatment with PEG-HbCO were reported by the investigator to show clear signs of improved mental function that was temporally associated with infusion of PEG-HbCO despite continuing low Hb levels. Improvements in cerebrovascular oximetry, cerebral blood flow, pulmonary infiltrates, renal function and serum biochemistry (bilirubin, liver function, LDH) were reported in various patients. A SCD patient with acute chest syndrome showed clearing of pulmonary infiltrate within 24 hours of PEG-HbCO infusion. Nine of eleven (81%) severely anemic patients showed improvement upon administration of PEG-HbCO, defined by an initial improvement in mental alertness and culminating in hospital discharge (excluding trauma patients with ISS score ≥25).
Conclusion
The varied results seen in these critical care patients represent preliminary evidence of substantial improvement in clinically significant endpoints used by the clinicians to assess response to treatment in the urgent care setting. Most important is the evidence of response despite no immediate improvement in the hemoglobin level which, if left untreated, may have lead many of these patients to significant morbidity and potential mortality. While severe anemia persisted for most of these patients, it appears that the life-threatening hypoxia did not. There is a significant unmet medical need to treat hypoxia in patients for whom blood is not an option. PEG-HbCO is under development for the treatment of the life-threatening effects of acute severe anemia (Hb ≤ 5 g/dL) in patients who cannot receive red blood cell transfusions. PEG-HbCO is also in clinical development for the treatment of SCD comorbidities, delayed graft function following renal transplantation and reduction of delayed cerebral ischemia following subarachnoid hemorrhage.
Session topic: Transfusion Medicine
Keyword(s): Bleeding, Blood transfusion, Hemoglobin, Hemolytic anemia
Abstract: S834
Type: Oral Presentation
Presentation during EHA21: On Sunday, June 12, 2016 from 08:15 - 08:30
Location: Room H6
Background
Severe hypoxia due to low hemoglobin (Hb) levels causes significant morbidity and mortality. This is of great concern for patients who cannot receive blood transfusions due to personal (i.e., Jehovah’s Witness) or medical (i.e., hyperhemolysis) reasons, or simply due to the lack of availability. PEGylated-carboxyhemoglobin (PEG-HbCO; SANGUINATE™) is a novel therapeutic agent designed to release carbon monoxide to reduce vascular inflammation and then transfer oxygen to hypoxic tissue and cells. PEG-HbCO has been used in 24 patients under the USA emergency Investigational New Drug (eIND) program. A retrospective analysis of these patients was performed.
Aims
Perform post-hoc analysis of clinical findings; their relationship to individual patient diagnosis/associated comorbidities and PEG-HbCO intervention.
Methods
23 patients with hemoglobin levels under 5 g/dL and 1 sickle cell disease patient with Hb of 8.7 were determined to be near death or at serious risk of severe morbidity and were treated with PEG-HbCO. Applications included AML, sickle cell disease (SCD) comorbidities, trauma and hemorrhagic shock. Patients ranged in age from 19 to 61. A unit of PEG-HbCO consists of 500 mL (40 mg/mL). Total doses ranged from 1 unit up to 8 units given over 9 days.
Results
No serious adverse events associated with PEG-HbCO were reported. All patients provided with timely emergency treatment with PEG-HbCO were reported by the investigator to show clear signs of improved mental function that was temporally associated with infusion of PEG-HbCO despite continuing low Hb levels. Improvements in cerebrovascular oximetry, cerebral blood flow, pulmonary infiltrates, renal function and serum biochemistry (bilirubin, liver function, LDH) were reported in various patients. A SCD patient with acute chest syndrome showed clearing of pulmonary infiltrate within 24 hours of PEG-HbCO infusion. Nine of eleven (81%) severely anemic patients showed improvement upon administration of PEG-HbCO, defined by an initial improvement in mental alertness and culminating in hospital discharge (excluding trauma patients with ISS score ≥25).
Conclusion
The varied results seen in these critical care patients represent preliminary evidence of substantial improvement in clinically significant endpoints used by the clinicians to assess response to treatment in the urgent care setting. Most important is the evidence of response despite no immediate improvement in the hemoglobin level which, if left untreated, may have lead many of these patients to significant morbidity and potential mortality. While severe anemia persisted for most of these patients, it appears that the life-threatening hypoxia did not. There is a significant unmet medical need to treat hypoxia in patients for whom blood is not an option. PEG-HbCO is under development for the treatment of the life-threatening effects of acute severe anemia (Hb ≤ 5 g/dL) in patients who cannot receive red blood cell transfusions. PEG-HbCO is also in clinical development for the treatment of SCD comorbidities, delayed graft function following renal transplantation and reduction of delayed cerebral ischemia following subarachnoid hemorrhage.
Session topic: Transfusion Medicine
Keyword(s): Bleeding, Blood transfusion, Hemoglobin, Hemolytic anemia
Type: Oral Presentation
Presentation during EHA21: On Sunday, June 12, 2016 from 08:15 - 08:30
Location: Room H6
Background
Severe hypoxia due to low hemoglobin (Hb) levels causes significant morbidity and mortality. This is of great concern for patients who cannot receive blood transfusions due to personal (i.e., Jehovah’s Witness) or medical (i.e., hyperhemolysis) reasons, or simply due to the lack of availability. PEGylated-carboxyhemoglobin (PEG-HbCO; SANGUINATE™) is a novel therapeutic agent designed to release carbon monoxide to reduce vascular inflammation and then transfer oxygen to hypoxic tissue and cells. PEG-HbCO has been used in 24 patients under the USA emergency Investigational New Drug (eIND) program. A retrospective analysis of these patients was performed.
Aims
Perform post-hoc analysis of clinical findings; their relationship to individual patient diagnosis/associated comorbidities and PEG-HbCO intervention.
Methods
23 patients with hemoglobin levels under 5 g/dL and 1 sickle cell disease patient with Hb of 8.7 were determined to be near death or at serious risk of severe morbidity and were treated with PEG-HbCO. Applications included AML, sickle cell disease (SCD) comorbidities, trauma and hemorrhagic shock. Patients ranged in age from 19 to 61. A unit of PEG-HbCO consists of 500 mL (40 mg/mL). Total doses ranged from 1 unit up to 8 units given over 9 days.
Results
No serious adverse events associated with PEG-HbCO were reported. All patients provided with timely emergency treatment with PEG-HbCO were reported by the investigator to show clear signs of improved mental function that was temporally associated with infusion of PEG-HbCO despite continuing low Hb levels. Improvements in cerebrovascular oximetry, cerebral blood flow, pulmonary infiltrates, renal function and serum biochemistry (bilirubin, liver function, LDH) were reported in various patients. A SCD patient with acute chest syndrome showed clearing of pulmonary infiltrate within 24 hours of PEG-HbCO infusion. Nine of eleven (81%) severely anemic patients showed improvement upon administration of PEG-HbCO, defined by an initial improvement in mental alertness and culminating in hospital discharge (excluding trauma patients with ISS score ≥25).
Conclusion
The varied results seen in these critical care patients represent preliminary evidence of substantial improvement in clinically significant endpoints used by the clinicians to assess response to treatment in the urgent care setting. Most important is the evidence of response despite no immediate improvement in the hemoglobin level which, if left untreated, may have lead many of these patients to significant morbidity and potential mortality. While severe anemia persisted for most of these patients, it appears that the life-threatening hypoxia did not. There is a significant unmet medical need to treat hypoxia in patients for whom blood is not an option. PEG-HbCO is under development for the treatment of the life-threatening effects of acute severe anemia (Hb ≤ 5 g/dL) in patients who cannot receive red blood cell transfusions. PEG-HbCO is also in clinical development for the treatment of SCD comorbidities, delayed graft function following renal transplantation and reduction of delayed cerebral ischemia following subarachnoid hemorrhage.
Session topic: Transfusion Medicine
Keyword(s): Bleeding, Blood transfusion, Hemoglobin, Hemolytic anemia
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