Ceplene
Ceplene is a pharmaceutical-grade form of histamine dihydrochloride, which is used for the prevention of relapse in patients diagnosed with acute myeloid leukemia (AML).
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[edit] Use of Ceplene in leukemia
Ceplene is administered in conjunction with low doses of the immune-activating cytokine interleukin-2 (IL-2) in the post-remission phase of AML, i.e. when patients have completed the initial chemotherapy. Ceplene/IL-2 has been reported to significantly reduce the risk of relapse in AML[1]. The effect is particularly pronounced in patients in their first remission who are below the age of 60[2].
The combination of Ceplene and interleukin-2 was approved for use in AML patients within the European Union in October 2008[3] and will be marketed in the EU by the Swedish pharmaceutical company Meda. Ceplene is also available through a named patient program in several other countries (excluding the US).
[edit] Proposed mechanism of action
Ceplene acts by improving the immune-enhancing properties of IL-2, and laboratory studies have shown that Ceplene/IL-2 can induce immune-mediated killing of leukemic cells[4]. The treatment (in the form of subcutaneous injections) is given in 3-week cycles by the patients at home for 18 months, thus coinciding with the period of highest relapse risk. The side-effects of Ceplene include transient flush and headache, whereas IL-2 may induce low-grade fever and inflammation at the site of injection. Ceplene has been developed by researchers at the University of Gothenburg, Sweden.
[edit] References
- ^ Brune M, Castaigne S, Catalano J, et al. (July 2006). "Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial". Blood 108 (1): 88–96. doi:10.1182/blood-2005-10-4073. PMID 16556892.
- ^ Romero AI, Thorén FB, Aurelius J, Askarieh G, Brune M, Hellstrand K (September 2009). "Post-consolidation immunotherapy with histamine dihydrochloride and interleukin-2 in AML". Scand. J. Immunol. 70 (3): 194–205. doi:10.1111/j.1365-3083.2009.02303.x. PMID 19703009.
- ^ www.emea.europa.eu/pdfs/human/opinion/Ceplene_39869108en.pdf - 2008-11-25
- ^ Hellstrand K, Asea A, Dahlgren C, Hermodsson S (December 1994). "Histaminergic regulation of NK cells. Role of monocyte-derived reactive oxygen metabolites". J. Immunol. 153 (11): 4940–7. PMID 7963557.
[edit] External links
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