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Title: Histamine Dihydrochloride Approved in Europe for Prevention of Relapse in Patients With AML
URL: http://www.pslgroup.com/dg/22E6C6.htm
Doctor's Guide
October 9, 2008

NEW YORK -- October 9, 2008 -- The European Commission has approved histamine dihydrochloride (Ceplene) in combination with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse in adult patients with acute myeloid leukaemia (AML) in first remission.

The approval is based, in part, on the results of the pivotal 320-patient phase 3 trial for histamine dihydrochloride in conjunction with IL-2. The primary result of this trial was that treatment with histamine dihydrochloride/IL-2 significantly reduced the occurrence of relapse among patients with AML in complete remission.

The improvement of long-term leukaemia-free survival in patients receiving histamine dihydrochloride/IL-2 exceeded 50%. Histamine dihydrochloride was generally well tolerated and conferred an acceptable risk benefit profile for patients with AML.

"The main challenge in AML treatment is to protect patients in their first complete remission from relapse, as a first relapse is associated with poor long-term survival. The combination of [histamine dihydrochloride] and IL-2 has been demonstrated to be a safe therapy that improves leukaemia-free survival by significantly reducing the risk of recurrent leukaemia," said principal investigator Mats Brune, MD, Sahlgrenska University, Gothenburg, Sweden.

As part of receiving marketing authorisation under exceptional circumstances, the manufacturer of the drug will conduct 2 postapproval clinical studies. One of the studies will seek to further elucidate the clinical pharmacology of histamine dihydrochloride by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of histamine dihydrochloride/IL-2 on the development of minimal residual disease in the same patient population.

SOURCE: EpiCept Corporation

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