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Immunological Safety Not a Problem with Bovine-Derived Human Blood Substitute: Presented at AAAAI
By Jill Stein
DENVER, CO -- March 10, 2003 -- Researchers report that the risk of systemic immunoglobulin E (IgE)-mediated reactions is negligible in patients receiving the bovine-derived human blood substitute Hemopure.
Hemopure is a an investigational product that is being developed as a treatment for the signs and symptoms of acute anaemia in adults undergoing orthopaedic surgery to eliminate reduce the need for red blood cell transfusions in these patients.
Dr. Maria Gawryl, with Biopure Corporation in Cambridge, Massachusetts, United States, and co-workers at Johns Hopkins University in Baltimore, Maryland, evaluated IgE and IgG immune responses in patients receiving multiple doses of Hemopure in clinical trials.
Dr. Gawryl presented the data here March 9th at the 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
His research team collected blood samples from patients treated with Hemopure and controls before and 4 to 6 weeks after treatment. Hemopure was administered in single or divided doses up to 300 g hemoglobin (2.5 L).
Results showed that Hemopure-specific IgG responses were detected in 54% of Hemopure-treated patients and 4.3% of control patients. Positive IgG antibody responses in control patients occurred at low frequency and concentration (range 2:1-16.8 kAU/mL) and may reflect either non-specific binding or cross-reacting antibodies.
In 497 Hemopure-treated and 416 control patients -- including patients who were infused multiple times over several weeks -- only one patient treated with Hemopure developed Hemopure-specific IgE antibodies 6 weeks after treatment (4.6 fold greater than negative control serum binding). Importantly, there were no serious adverse events reported in this patient. Non-serious events included an elevated temperature and itching in the perineal area.
One control patient and five Hemopure patients had IgE antibody responses designated as equivocal (less than 3 fold negative control serum binding). This IgE antibody level was too low to permit competitive soluble antigen inhibition for specificity confirmation, and it was not considered significant.
Dr. Gawryl said the results provide evidence that Hemopure is well tolerated in various clinical settings at a variety of doses and support its use as a red blood cell replacement in the surgical setting. Clinical experience in South Africa, where the solution is approved for surgical use, supports this conclusion, he said.
The study was sponsored by Biopure Corporation in Cambridge, Massachusetts.
[Study title: Immunologic Safety Studies of Bovine-Derived Human Blood Substitute (Hemopure). Abstract 390]
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