EpiCept has provided an update on new clinical developments and other initiatives related to Ceplene (histamine dihydrochloride) therapy, approved in the EU, for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first remission.
EpiCept also plans to initiate two new studies for Ceplene and provided an update on another study for Ceplene intended to help achieve an expanded indication and broaden use for the drug.
A Phase I/II study will research the effects of a regimen of Ceplene and low-dose interleukin-2 (IL-2) in combination with Gleevec (imatinib mesylate) on the eradication of minimal residual disease (MRD) in adult patients with chronic myeloid leukemia. The primary objective of the study will be to assess the safety of the combination therapy of Ceplene/IL-2 with Gleevec given for six months and to assess the number of patients achieving and subsequently maintaining disease-free survival after discontinuation of Gleevec.
Patients will be followed for a minimum of 18 months after discontinuation of Gleevec therapy. MRD will be followed using a specific market resulting from a chromosomal abnormality found in CML.
The initiation of a study led by GFM (Groupe Francophone des Myelodysplasies) will examine the effects of Ceplene/IL-2 in combination with Vidaza (azacitidine) in the treatment of patients with higher risk myelodsyplastic syndromes (MDS). These patients will already have demonstrated a hematological response to Vidaza. This trial will be followed by a randomised Phase II study of the efficacy, safety and tolerability of the addition of Ceplene/IL-2 to Vidaza, compared to Vidaza alone, in patients with higher risk MDS and who have achieved hematological response to Vidaza.
The post-approval clinical study of Ceplene was initiated in July 2009 and is studying the effects of remission maintenance therapy with Ceplene/IL-2 on MRD in adult patients with AML in first complete remission. This open-label, multicenter study will also assess the quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on these patients by monitoring T and natural killer cell phenotypes and their functionality after the first and third treatment cycles.
Enrollment in this study is ongoing and the study will enroll up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the UK, Spain and Italy.