部份中文二盐酸组胺处方资料（仅供参考）
中文名称:二盐酸组胺
剂型规格:0.5mg/0.5ml/瓶
适应症：急性髓系白血病
作用机理: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。
Ceplene治疗的适应症包括多种肿瘤，其中针对恶性黑色素瘤、急性髓细胞白血病、多发性骨髓瘤、肾癌均已不同国家进入了III期临床试验。美国FDA已经授予该药治疗急性髓细胞白血病和恶性黑色素瘤的罕见药资格。
Ceplene(histamine dihydrochloride)
About Ceplene®
Ceplene, Cytovia’s lead drug, is a first-in-class immunotherapy that harnesses the immune system to effectively maintain remission in patients with Acute Myeloid Leukemia (AML). Ceplene unlocks activity of Interleukin-2 in patients with AML by activating the immune system’s T- cells and Natural Killer (NK)-cells. This combination therapy of Ceplene and IL-2 meets a material, unmet need for effective treatment in AML care.
Ceplene functions in AML by reducing the immunosuppressive effects of reactive oxygen species on T- cells and NK- cells, permitting their effective activation by IL-2 in order to eliminate residual leukemic cells in patients who are in clinical complete remission. IL-2 activates and proliferates T and NK cells, while Ceplene protects these cells against inactivation and apoptosis. The result is a stimulatory effect on the immune system to support the elimination of Leukemic cells and protection against relapse.
The clinical relevance of Ceplene, an Orphan Drug, in combination with low dose subcutaneous IL-2 was demonstrated in a Phase III clinical study with 320 US and global AML patients. The study successfully met its primary endpoint of determining the efficacy of Ceplene and IL-2 on patients’ Leukemia-Free Survival (LFS). Ceplene is proven to prevent relapse in AML patients in first remission and to prolong LFS while preserving quality of life during treatment. Three years after first remission, 40% of patients were leukemia free, as opposed to only 26% of control patients. Additionally, a European Phase IV study presented at the American Academy of Cancer Research in 2016 confirmed clinical benefits of Ceplene and IL-2 and helped to define biomarkers predictive of survival.
Additional analysis of a subgroup of patients with the mutated oncogene NPM1 suggests a potential benefit of Ceplene and IL-2 in this high-risk patient group of hematological cancers, including AML where the probability of leukemia relapse is over 80%.
Ceplene in combination with low dose subcutaneous IL-2 is approved in the European Union for remission maintenance in AML patients. Under guidance from the FDA, Cytovia intends to leverage recent data to design the REMAIN Study, a global trial to prove Ceplene’s efficacy in Overall Survival in AML to support Cytovia’s New Drug Application in the U.S.
Cytovia seeks to expand the potential relevance of Ceplene and IL-2 for new indications, including Chronic Myelomonocytic Leukemia (CMML) and Chronic Myelocytic Leukemia (CML) through pilot, investigator sponsored clinical trials.
Cytovia is further exploring Ceplene in combination with Checkpoint Inhibitors and IL-15 for new indications in Melanoma and Renal Cell Carcinoma. Recent data also suggests that Ceplene significantly enhances the anti-tumor efficacy of Checkpoint Inhibitors targeting PD-1 and PDL-1 in lymphoma and breast cancer, thus forming the basis for clinical development of Ceplene and other immune checkpoint inhibitors in multiple tumor types. 
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