EpiCept has initiated a post-approval clinical study with Ceplene (histamine dihydrochloride), following Ethics Committee and Competent Authority approvals in Sweden, Belgium and France.
The company said that the study will fulfill the post-approval commitments requested by the EMEA in granting marketing authorisation.
Ceplene is indicated for remission maintenance in adult patients with acute myeloid leukaemia in first remission.
Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2).
This study will enroll up to 150 patients at approximately 25 centres across Europe, with sites in Sweden, Belgium, France, the UK, Spain and Italy.
EpiCept president and CEO Jack Talley said that the company was working with a number of market leaders.
“We are pleased to begin this study under the leadership of study chair and principal investigator Dr Robin Foa in Rome, Italy and co-principal investigator Dr Mats L Brune in Gothenburg, Sweden and to be working closely with a broad network of haematology thought leaders,” said Talley.
“The commencement of this trial meets our post-approval commitment to the EMEA and underscores our determination to move forward as quickly as possible with the commercial launch of the drug in the EU. Ceplene is an important therapy for AML patients because it is the only medical therapy ever proven to prevent relapse in this deadly disease.”