Abstract | BACKGROUND: The heteropolymer technology was developed to remove pathogens from the circulation. OBJECTIVES: To evaluate the safety and tolerability of a single administration and to establish proof of principle for ETI-104 in normal healthy volunteers (NHV) and patients with systemic lupus erythematosus (SLE) METHODS: The drug was given intravenously to 11 NHV and six patients with SLE. Over 28 days, vital signs were noted, a haematological and chemical analysis of blood and urine was carried out, and adverse events were recorded. CR1 receptor numbers, the ability of antigen based heteropolymers to bind to red blood cells (RBCs), and the clearance of high avidity and total anti-dsDNA antibodies were measured by Farr assays and FACS analysis. RESULTS: No safety measure differed significantly from normal in both groups; no drug related serious adverse events occurred. ETI-104 rapidly bound to RBCs in NHV and patients with SLE. Binding of the drug to RBCs of patients with SLE also caused a rapid reduction of circulating anti-dsDNA antibodies in the plasma 15 minutes after administration, with a maximum reduction of 55% (range 43-62). At 28 days statistically significant decreases were maintained in three patients, while in the other three the values had returned to baseline levels. CONCLUSION:
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Authors | C Iking-Konert, S Stocks, F Weinsberg, R Engelbrecht, E Bleck, A Perniok, R Fischer-Betz, S Pincus, L Nardone, M Schneider |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 63
Issue 9
Pg. 1104-12
(Sep 2004)
ISSN: 0003-4967 [Print] England |
PMID | 15308520
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Antibodies, Antinuclear
- ETI104
- Immunoconjugates
- Receptors, Complement 3b
- DNA
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Topics |
- Adult
- Antibodies, Antinuclear
(blood)
- Antibody Affinity
- Cells, Cultured
- DNA
(immunology)
- Erythrocytes
(metabolism)
- Female
- Humans
- Immunoconjugates
(adverse effects, blood, therapeutic use)
- Lupus Erythematosus, Systemic
(immunology, therapy)
- Male
- Middle Aged
- Receptors, Complement 3b
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