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
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.