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Sulesomab Fab' fragment

Summary

Sulesomab Fab' fragment (Leukoscan) is a product consisting of the monomeric Fab' fragment of the granulocyte-binding antibody Sulesomab. Sulesomab itself has binding activity to both carcinoembryonic antigen (CEA) and surface granulocyte non-specific crossreacting antigen (NCA-90) and is prepared in murine ascites fluid. It is supplied in kit form for radiolabeling with Technetium-99m. Upon intravenous infusion of the radiolabeled product, binding to circulating neutrophils and to leukocytes already present at the site ofinfection is reported to occur, enabling imaging of occult sites of infection, specifically osteomyelitis. This agent is marketed as an alternative to White Blood Cell Scanning with Indium-111 or Technetium-99m hexamethyl propylene amine oxime. In a recent review on in-vivo leukocyte labeling, Palestro reports that clinical studies have shown variable sensitivity and specificity in the detection of suspected musculoskeletal infection.

Leukoscan has been approved for use in Australia, Canada, and the European Union.

Brand Name

Leukoscan

Other Names

IMMU-MN3

Molecular Target

CEA (carcinoembryonic antigen);
NCA-90 (surface granulocyte non-specific cross-reacting antigen) on neutrophils

Molecular Structure

murine monoclonal anti-granulocyte Fab'-SH fragments for conjugation with Tc-99m

Licensed Indication, Major Target Diseases

Diagnostic imaging of infection/inflammation in bone (suspected osteomyelitis); marketed/approved in European Union

Manufacturer/Distributor

Immunomedics GmbH

References

 Source  Link  Revision Date
 Access Date
Leukoscan EPAR Summary of Product Characteristics
http://www.emea.europa.eu/humandocs/.../leukoscan.htm  2007-May-20  2008-June-03
Leukoscan EPAR Scientific Discussion http://www.emea.europa.eu/humandocs/.../leukoscan.htm 2002-October-01
 2008-June-03
Palestro CJ. In vivo leukocyte labeling: the quest continues. J Nucl Med. 2007 Mar;48(3):332-4 http://jnm.snmjournals.org/cgi/content/full/48/3/332


Rubello D, Casara D, et al. Role of anti-granulocyte Fab' fragment antibody scintigraphy (LeukoScan) in evaluating bone infection: acquisition protocol, interpretation criteria and clinical results. Nucl Med Commun. 2004 Jan;25(1):39-47
http://www.ncbi.nlm.nih.gov/pubmed/15061263


Devillers A, Garin E, et al. Comparison of Tc-99m-labelled antileukocyte fragment Fab' and Tc-99m-HMPAO leukocyte scintigraphy in the diagnosis of bone and joint infections: a prospective study. Nucl Med Commun. 2000 Aug;21(8):747-53
http://www.ncbi.nlm.nih.gov/pubmed/11039458

2008-June-03
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