|Product / Indication||Phase One||Phase Two||Phase Three||Registration||Market|
Ceplene®Europe - Acute Myeloid Leukemia
Ceplene®United States - Acute Myeloid Leukemia
Acute Myeloid Leukemia Remission Maintenance Therapy
EU Big 5 34,000 patients
Total EU 47,000 patients
Dosage and Administration
Ceplene®: 0.5 mg, bid, sub-q Interleukin-2 (Proleukin®): 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
Well tolerated with mild flushing, headache and fatigue
Ceplene® IL-2 self-administered at home
Ceplene® (histamine dihydrochloride), which has received marketing authorization by the European Commission, is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first 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 16,400 new cases occurring each year. There are currently no other effective medical-based remission therapies for AML patients.
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis, 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
The European Commission has approved Ceplene® for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission. Marketing rights have been licensed to Meda AB. In the U.S., Ceplene® is in Phase III. A pivotal trial to study Ceplene® in AML remission using overall survival as the primary endpoint is expected to commence in 2011. Ceplene® has been granted orphan drug status for the treatment of AML by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).