EpiCept Corporation (Nasdaq and OMX Stockholm Exchange: EPCT) announced today that the Swedish AML Group which comprises the leading hematology experts in Sweden has included Ceplene® (histamine dihydrochloride) in its Guidelines entitled “National Guidelines for Diagnosis and Treatment of Acute Myeloid Leukemia in Adults.” These guidelines, which were issued earlier this month, recommend for the first time the inclusion of Ceplene for AML remission maintenance therapy. Ceplene plus low-dose interleukin (IL-2) is indicated for remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission by the European Medicines Evaluation Agency (EMEA).
Earlier this month, EpiCept entered into an exclusive commercialization agreement for Ceplene with Meda AB, (OMX Stockholm Exchange: MEDA-A-ST) a leading international specialty pharmaceutical company based in Stockholm. Meda is expected to launch Ceplene this year.
“The issuance of these medical guidelines is a significant step forward in recognizing the importance of Ceplene plus IL-2 as a remission maintenance therapy for patients suffering from AML in Europe, as it raises the awareness among physicians for this life-saving medicine,” remarked Jack Talley, President and CEO of EpiCept. “Ceplene will be able to be utilized without restrictions upon its commercial launch by Meda, while in the meantime it is available through the Named Patient Program at Idis. The guidelines also make reference to our ongoing Phase IV study, a post-approval clinical study. This study is intended to further demonstrate the clinical pharmacology of Ceplene by assessing certain immunologic biomarkers in AML patients in first remission, and to measure the effect of Ceplene/IL-2 on minimal residual disease in the same patient population. Secondary objectives will assess leukemia-free survival after a follow-up period of up to two years,” Mr. Talley added. EpiCept intends to work with the European Leukemia Net (ELN) and other national authorities in Europe along with Meda to incorporate Ceplene into AML practice guidelines consistent with the approved labeling.
About Ceplene
Ceplene is indicated for remission maintenance therapy and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML). Ceplene is used together with low dose Interleukin-2. AML is one of four major types of leukemia. The prevalence for AML in the EU is about 41,000 patients and over 16,000 new cases are diagnosed every year. While current induction and consolidation treatments are successful in inducing complete remission for the majority of AML patients, this remission is generally short-lived. After achieving complete remission most patients will suffer a relapse within one year. In an international, multicenter, open-label, randomized phase III study, Ceplene met its primary endpoint of prolonging leukemia-free survival for AML patients in remission. The difference between the treated and control group was highly statistically significant (p