Treatment of infant bronchiolitis with recombinant human interferon alpha-1b by different administration routes: a randomized, Placebo-controlled, multi-center clinical trial

开始日期2014-10-15

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100 项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的临床结果

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100 项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的转化医学

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100 项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的专利（医药）

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项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的文献（医药）

2024-09-01·Molecular Genetics and Metabolism

Clinical insight meets scientific innovation to develop a next generation ERT for Pompe disease

Review

作者: Chien, Yin-Hsiu ; Berger, Kenneth I ; Thibault, Nate ; Kishnani, Priya S ; Sparks, Susan

Years of research into the structure, processing, and function of acid alpha-glucosidase led to the development and 2006 approval of alglucosidase alfa (recombinant human acid alpha-glucosidase, Myozyme®/Lumizyme®), an enzyme replacement therapy and the first approved treatment for Pompe disease. Alglucosidase alfa has been a lifesaving treatment for patients with infantile-onset Pompe disease and radically improved daily life for patients with late-onset Pompe disease; however, long-term experience with alglucosidase alfa unraveled key unmet needs in these populations. Despite treatment, Pompe disease continues to progress, especially from a skeletal muscle perspective, resulting in a multitude of functional limitations. Strong collaboration between the scientific and patient communities led to increased awareness of Pompe disease, a better understanding of disease pathophysiology, knowledge of the clinical course of the disease as patients surpassed the first decade of life, and the strengths and limitations of enzyme replacement therapy. Taken together, these advancements spurred the need for development of a next generation of enzyme replacement therapy and provided a framework for progress toward other novel treatments. This review provides an overview of the development of avalglucosidase alfa as a model to highlight the interaction between clinical experience with existing treatments, the role of the clinician scientist, translational research at both system and cellular levels, and the iterative and collaborative process that optimizes the development of therapeutics.

1986-01-01·Japanese journal of cancer research : Gann

Inhibition of intravascular mouse melanoma dissemination by recombinant human interferon alpha A/D.

Article

作者: Nakao Ishida ; Hisashi Aso ; Takusaburo Ebina ; Osamu Yoshie ; Takahiko Yokoyama

The effects of pure recombinant human interferon alpha A/D (IFN alpha A/D) on natural killer (NK) activity and the experimental lung metastasis of B16-F10 melanoma were studied. Treatment of C57BL/6 mice with IFN alpha A/D augmented splenic NK activity and also inhibited the experimental lung metastasis of B16-F10 melanoma in a dose-dependent manner. The augmentation of NK activity and the inhibition of experimental lung metastasis by IFN alpha A/D were completely abolished in anti-asialo GM1-pretreated mice. These results suggested that the effector cells which inhibited melanoma metastasis in the present system were mainly NK cells, and that it was by activating NK cells that IFN alpha A/D had its effect. We next studied the timing of IFN alpha A/D administration for the most effective prevention of melanoma metastasis. The inhibitory effect of IFN alpha A/D was most pronounced when it was given 12 hr before or at the same time as melanoma inoculation. This suggested that melanoma cells were susceptible to NK cells only for a short period of time after intravascular invasion.

Journal of Medical Case Reports

Enzyme replacement therapy and immunotherapy lead to significant functional improvement in two children with Pompe disease: a case report

Article

作者: Sánchez-Peñarete, Diana ; Ruiz-Ospina, Edicson ; Manrique-Hernández, Daniel ; Correa-Arrieta, Cristian ; Castellar-Leones, Sandra Milena ; Ortiz-Corredor, Fernando ; Soto-Peña, Diana

AbstractBackgroundPompe disease, a rare autosomal recessive disorder caused by acid alpha-glucosidase deficiency, results in progressive glycogen accumulation and multisystem dysfunction. Enzyme replacement therapy with recombinant human acid alpha-glucosidase is the standard of care; however, some patients develop anti-recombinant human acid alpha-glucosidase antibodies, leading to reduced efficacy. This case report presents two infants with early-onset Pompe disease who developed IgG antibodies to enzyme replacement therapy and were subsequently treated with methotrexate, highlighting the importance of monitoring antibody development and exploring alternative therapeutic approaches.Case presentationPatient 1, a 10-month-old female from Bogota, Colombia, presented with generalized hypotonia, macroglossia, hyporeflexia, and mild left ventricular hypertrophy. Diagnostic tests confirmed early-onset Pompe disease, and enzyme replacement therapy was started at 12 months. Due to a lack of improvement and high anti-recombinant human acid alpha-glucosidase IgG antibody titers (1:1800), methotrexate was started at 18 months. After 8 months of combined therapy, antibody titers were negative and significant improvement in motor function was observed using the Gross Motor Function Measure 88. Patient 2, a 7-year-old female from Bogota, Colombia, was diagnosed with early-onset Pompe disease at 12 months and initiated enzyme replacement therapy. At 5 years of age, she experienced frequent falls and grip strength alterations. Functional tests revealed motor development delay, generalized hypotonia, and positive anti-recombinant human acid alpha-glucosidase IgG antibody titers (6400). Methotrexate was initiated, leading to a reduction in falls and antibody titers (3200) after 6 months, with no adverse events or complications. Motor function improvement was assessed using the Motor Function Measurement 32.ConclusionsThe presented cases highlight the importance of monitoring patients for anti-recombinant human acid alpha-glucosidase antibody development during enzyme replacement therapy and the potential benefit of methotrexate as an immunomodulatory agent in early-onset Pompe disease. Early diagnosis and timely initiation of enzyme replacement therapy, combined with prophylactic immune tolerance induction, may improve clinical outcomes and reduce the development of anti-recombinant human acid alpha-glucosidase antibodies. The cases also highlight the importance of objective motor function assessment tools, such as Gross Motor Function Measure 88 and Motor Function Measurement 32, in assessing treatment response. Further research is needed to optimize treatment regimens, monitor long-term effects, and address the current limitations of enzyme replacement therapy in Pompe disease.

项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的新闻（医药）

2024-10-03

·中国生物

松辽平原腹地上的生物制品研究所丨与祖国共成长③

七十五载岁月峥嵘各族人民团结一心、砥砺奋进在这波澜壮阔的历史画卷中座落在白山黑水之间松辽平原腹地的中国生物长春生物制品研究所默默耕耘为守护人民生命健康作出重要贡献长春生物制品研究所始建于1946年前身为东北卫生技术厂 ▲1946年，由长春迁至佳木斯的东北卫生技术厂旧址 1949年10月辽吉军区卫生技术厂与东北卫生技术厂合并 ▲卫生技术厂职工合影 1952年东北林区发现不明原因脑炎样疾病后经证实为森林脑炎长春生物制品研究所立即开展森脑疫苗的研制工作次年制备出鼠脑和鸡胚组织灭活疫苗在森脑流行季前发至疫区使用 1957年长春生物制品研究所首次用鸡胚培养分离出亚洲甲型流感病毒同年，大连卫生研究所鼠疫菌苗室合并于长春生物制品研究所 1959年卡介苗，百日咳、白喉二联苗正式生产 1960年长春生物制品研究所开始生产吸附精制破伤风类毒素对我国破伤风类毒素生产作出贡献 1966年麻疹疫苗研制成功采用独立筛选的“长47”减毒株进行生产 1969年 A群流脑菌苗投产 1989年10月长春生物制品研究所建成中国第一个基因工程干扰素中试基地 1990年长春生物制品研究所研制的国内第一个基因工程产品重组人干扰素α1b滴眼液获得新药证书和试生产文号 1991年11月中国第一个乙肝基因工程疫苗工业化生产基地建成 1992年长春生物制品研究所获得国内首家甲肝减毒活疫苗试生产文号 1994年4月获得注射用重组人白介素-2 国内首个生产文号 1999年6月新建的血液制剂车间通过了GMP认证现场检查是吉林省首家通过GMP认证的企业 2000年长春生物制品研究所相继获得冻干水痘减毒活疫苗冻干甲型肝炎减毒活疫苗新药证书和生产文号获得重组人干扰素α2b注射剂重组人GM-CSF（集落细胞刺激因子）生产文号 2004年获得流感病毒裂解疫苗生产文号 2004年森林脑炎灭活疫苗（纯化）研制成功 2009年为应对“甲流”大流行科研人员在短短3个月时间内成功建立起研制甲型H1N1流感病毒裂解疫苗的技术平台 2013年7月无硫柳汞流感病毒裂解疫苗上市质量达到国内领先水平 2020年四价流感病毒裂解疫苗获批上市并实现产业化 2021年4月冻干人用狂犬病疫苗（Vero细胞）获批上市 2023年流感病毒裂解疫苗通过世卫组织预认证正式加入联合国采购清单七十多年的发展历程里长春生物制品研究所历经搬迁、合署、更迭但始终踏浪逐新走上了高质量发展的快车道未来可期逐梦前行来源：长春生物制品研究所搜索“中国生物” 关注中国生物全媒体矩阵

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100 项与重组人干扰素α1b滴眼液 (长春生物制品研究所) 相关的药物交易

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