二盐酸组胺冻干粉注射剂Ceplene 0.5mg/0.5ml




所属类别: 0.5毫克/0.5毫升/瓶 14瓶/盒

包装规格: 0.5毫克/0.5毫升/瓶 14瓶/盒




原产地英文商品名:CEPLENE 0.5mg/0.5ml/vial 14vials/box


中文参考商品译名:CEPLENE 0.5毫克/0.5毫升/瓶 14瓶/盒





氧自由基抑制剂,恶性肿瘤及丙型肝炎治疗药物给药方式:皮下注射开发公司:Maxim制药公司简介二盐酸组胺注射剂(histamine dihydrochloride,Ceplene)批准上市,是用于持续缓解和防止急性髓细胞样白血病(AML)成人患者首次缓解治疗后的复发新剂型。本品应与小剂量白介素-2联合用药。Maxim制药公司开发了组胺二盐酸盐,这种化合物可以特异性地阻断可以诱导自然杀伤细胞凋亡的吞噬细胞信号。该化合物可以抑制氧自由基的产生和释放,并以次增强T细胞和自然杀伤细胞激活的细胞因子的活性。氧自由基可以抑制T细胞和自然杀伤细胞的抗病毒和抗肿瘤的功能。Ceplene和干扰素或细胞因子联合使用可以治疗多种恶性肿瘤和丙型肝炎,这种联合治疗方式已经被命名为Ceplene治疗。




CepleneCeplene generically named histamine dihydrochloride, is our proprietary product approved for the remission maintenance and prevention of relapse in adult patients with AML in first remission.Ceplene is to be administered in conjunction with low-dose IL-2.Ceplene is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Ceplene reduces the formation of oxygen radicals from phagocytes, inhibiting nicotinamide adenine dinucleotide phosphate-oxidase, or NADPH oxidase, and protecting IL-2-activated Natural Killer cells, orNK-cells, and Thymus cells, or T-cells. These two kinds of cells, NK-cells and T-cells, possess an ability to kill and support the killing of cancer cells and virally infected cells.In October 2008, we received a full marketing authorization from the European Commission, or EU, for Ceplene®. The approval allows Ceplene to be marketed in the 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway. The approval by the European Commission is based, in part, on the results of the pivotal 320-patient Phase III trial for Ceplene® in conjunction with IL-2.The primary result of this trial was that treatment with Ceplene/IL-2 significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukemia-free survival in patients receiving Ceplene/IL-2 exceeded 50%. Moreover, Ceplene® was well tolerated in this patient population and conferred an acceptable risk benefit profile for AML patients.Ceplene was designated as an orphan medicinal product in the EU on April 11, 2005 for the treatment of AML. As a result of its designation as an Orphan Medical Product, we have been granted 10 years of market exclusivity in the EU for Ceplene. As part of receiving marketing authorization under Exceptional Circumstances for Ceplene, we will perform two post-approval clinical studies.One of the studies will seek to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in AML patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. We are considering combining these studies into a single clinical trial.We have also advanced our efforts to gain approval for Ceplene as a remission maintenance treatment for AML patients in North America.In December 2008, we received permission to proceed with a New Drug Submission filing for Ceplene with Health Canada for the treatment of AML in Canada. In January 2009, we received permission to proceed with a New Drug Application Filing for Ceplene® with the U.S. FDA.AML is the most common type of acute leukemia in adults. There are approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Additionally, there are approximately 12,000 new cases of AML and 9,000 deaths caused by this cancer each year in the United States.Indication:Acute Myeloid Leukemia Remission Maintenance TherapyTarget Population:EU Big 5 34,000+ patientsTotal EU 47,000+ patientsDescription:Histamine DihydrochlorideDosage and Administration:Ceplene: 0.5 mg, bid, sub-q +Interleukin-2 (Proleukin®): 16,400 IU/kg, bid, sub-qTreatment comprises 10 cycles3 cycles comprised of 3 weeks of treatment, followed by 3 weeks of rest7 cycles comprised of 3 weeks of treatment, followed by 6 weeks of restAdverse:Reactions Well tolerated with mild flushing, headache and fatigueCeplene + IL-2 self-administered at homeDescriptionCeplene (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 DevelopmentThe 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, which expects to launch the productcommercially in 2010. An NDS was filed and accepted in Canada in 2009, and an NDA filing is expected in the U.S. in 2010. Ceplene has been granted orphan drug status for the treatment of AML by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA). A Named Patient Program has been established to make Ceplene available in most countries of the world except for the U.S.

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