| Indication | Acute Myeloid Leukemia Remission Maintenance Therapy |
| Target Population |
EU Big 5 34,000+ patients Total EU 47,000+ patients |
| Description | Histamine Dihydrochloride + low dose Interleukin-2 (Proleukin®) |
| Dosage and Administration |
Ceplene: 0.5 mg, bid, sub-q + IL-2: 16,400 IU/kg, bid, sub-q Treatment comprises 10 cycles 3 cycles comprised of 3 weeks of treatment, followed by 3 weeks of rest 7 cycles comprised of 3 weeks of treatment, followed by 6 weeks of rest |
| Adverse Reactions |
Well tolerated with mild flushing, headache and fatigue Ceplene + IL-2 self-administered at home |
| Experience |
Completed an international, multi-center, randomized Phase III trial in 320 patients with AML |
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Ceplene™: Significant Improvement in LFS, ITT Set
Description
Ceplene (histamine dihydrochloride) is EpiCept’s lead oncology compound, administered in conjunction with low dose interleukin-2 (IL-2), for the maintenance of remission in patients with Acute Myeloid Leukemia (AML). AML is the most common type of leukemia in adults. There are approximately 12,000 new cases of AML and 9,000 deaths caused by this cancer each year in the U.S. There are approximately 47,000 AML patients in the EU, with 14,000 new cases occurring each year. There are currently no effective medical-based remission therapies for AML patients.
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, sometimes followed by consolidation therapy, and typically become free of detectable leukemia ("complete remission"). However, the majority of patients will experience a relapse of leukemia, usually within one to two years. The survival prognosis after a leukemic relapse is poor. Approximately 75-80 percent of patients who achieve their first complete remission will relapse, and the median time in remission before relapse is only 12 months with current treatments.
Treatment with Ceplene in conjunction with low dose IL-2 is designed to prevent leukemic relapses in AML patients in remission and prolong leukemia-free survival while maintaining a good quality of life for patients during treatment. In a Phase III clinical study of 320 patients, Ceplene met its primary endpoint of increased leukemia-free survival (p <0.01) among AML patients in remission. The results of this trial were published in Blood, a leading scientific journal in hematology, (Blood; The Journal of the American Society of Hematology, volume 108, number 1, pp. 88-96, July 1, 2006).
Stage of Development
On October 6, 2006, EpiCept filed a Marketing Authorization Application (MAA) in Europe for Ceplene with the European Medicines Agency for the Evaluation of Medicinal Products (EMEA). This MAA is being reviewed under the centralized licensing procedure which, if approved, would provide a marketing license for Ceplene in all member states of the EU together with Iceland, Liechtenstein and Norway. Ceplene had previously been granted orphan drug status for The next milestone on Ceplene's path to approval is the "Day 181" oral explanation, which is scheduled to occur in the first quarter of 2008, following which a recommendation for approvability from the Committee for Medicinal Products for Human Use (CHMP) and a final decision by the European commission is anticipated.