卡介菌纯蛋白衍生物（成都可恩生物科技）(BCG-PPD(Chengdu Coen Biotechnology))

概要

基本信息

药物类型

其他体内诊断药物、变应原提取物

别名-

靶点-

作用机制-

治疗领域

感染

在研适应症

结核

非在研适应症-

原研机构

成都可恩生物科技有限公司

在研机构

成都可恩生物科技有限公司

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

4

项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的临床试验

CTR20222278 / Completed临床2期

卡介菌纯蛋白衍生物在 18-65 岁健康受试者和结核病受试者中的 II 期临床试验

（与同类药物相比）评估卡介菌纯蛋白衍生物在健康人群、卡介苗接种后健康人群和结核病人群中的变态反应原性及安全性。

开始日期2022-11-15

申办/合作机构

成都可恩生物科技有限公司

CTR20221077 / Completed临床1期

随机、盲法、同类已上市制品对照，卡介菌纯蛋白衍生物（BCG-PPD）在6-65岁结核病受试者中应用的安全性和初步有效性预评估Ⅰ期临床试验

主要目的： 1)评估卡介菌纯蛋白衍生物在结核病受试者中的安全性。次要目的： 2)评估卡介菌纯蛋白衍生物在结核病受试者中初步的有效性。

开始日期2022-06-06

申办/合作机构

成都可恩生物科技有限公司

CTR20220386 / Completed临床1期

随机、盲法、同类已上市制品对照，卡介菌纯蛋白衍生物（BCG-PPD）在健康受试者中应用的安全性和初步有效性预评估Ⅰ期临床试验

初步评价单剂量BCG-PPD试验药物的安全性

开始日期2022-03-12

申办/合作机构

成都可恩生物科技有限公司

100 项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的临床结果

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100 项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的转化医学

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100 项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的专利（医药）

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22

项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的文献（医药）

2010-09-01·The AAPS Journal3区 · 医学

Pulmonary Immunization Using Antigen 85-B Polymeric Microparticles to Boost Tuberculosis Immunity

3区 · 医学

Article

作者: Liu, Jian ; Xu, Ding ; Padilla, Danielle ; Braunstein, Miriam ; Hickey, Anthony James ; McMurray, David N. ; Garcia-Contreras, Lucila ; Muttil, Pavan ; Lu, Dongmei

This study aims to evaluate immunization with polymeric microparticles containing recombinant antigen 85B (rAg85B) delivered directly to the lungs to protect against tuberculosis. rAg85B was expressed in Escherichia coli and encapsulated in poly(lactic-co-glycolic acid) microparticles (P-rAg85B). These were delivered as dry powders to the lungs of guinea pigs in single or multiple doses of homologous and heterologous antigens. Bacille Calmette-Guérin (BCG) delivered subcutaneously was employed as the positive control and as part of immunization strategies. Immunized animals were challenged with a low-dose aerosol of Mycobacterium tuberculosis (MTB) H37Rv to assess the extent of protection measured as reduction in bacterial burden (CFU) in the lungs and spleens of guinea pigs. Histopathological examination and morphometric analysis of these tissues were also performed. The heterologous strategy of BCG prime-P-rAg85B aerosol boosts appeared to enhance protection from bacterial infection, as indicated by a reduction in CFU in both the lungs and spleens compared with untreated controls. Although the CFU data were not statistically different from the BCG and BCG-BCG groups, the histopathological and morphometric analyses indicated the positive effect of BCG-P-rAg85B in terms of differences in area of tissue affected and number and size of granulomas observed in tissues. P-rAg85B microparticles appeared to be effective in boosting a primary BCG immunization against MTB infection, as indicated by histopathology and morphometric analysis. These encouraging observations are relevant to boosting adults previously immunized with BCG or exposed to MTB, commonly the case in the developing world, and should be followed by further assessment of an appropriate immunization protocol for maximum protection.

2009-03-01·Dental Materials1区 · 工程技术

Effect of co-initiator ratio on the polymer properties of experimental resin composites formulated with camphorquinone and phenyl-propanedione

1区 · 工程技术

Article

作者: Simonides Consani ; Larissa M. Cavalcante ; Luis Felipe J. Schneider ; Jack L. Ferracane

OBJECTIVESTo evaluate the effect of amine ratio (ethyl 4-dimethylaminobenzoate, EDMAB) on the maximum rate of polymerization (R(p)(max)), degree of conversion (DC), Knoop hardness (KH), water sorption (Wsp), water solubility (Wsl) and color changes (DeltaE) over time of resin composites formulated with the photoinitiators camphorquinone (CQ), phenylpropanedione (PPD) and CQ-PPD in combination.MATERIALS AND METHODSExperimental resin composites were made with photoinitiator:amine ratios of 2:1, 1:1, 1:1.5 and 1:2 by weight. R(p)(max) was evaluated with differential scanning calorimetry (DSC), DC with DSC and Fourier transformed infrared (FTIR) spectroscopy, KH with Knoop indentation, Wsp and Wsl adapted from ISO 4049; and color with a chromameter. The results were analyzed with two-way ANOVA/Tukey's multiple comparison test (p<0.05).RESULTSThe higher the amine ratio in the composite, the higher was DC, R(p)(max), and KH, and the lower was Wsl, regardless of the photoinitiator type. The use of PPD alone resulted in poorer properties than CQ and CQ-PPD. Many factors seem to affect the color changes and the b-axis data revealed that the higher the amine ratio, the higher was the +b value (yellowing) for CQ and CQ-PPD formulations.CONCLUSIONSHigher amine ratios led to improved polymer properties, but also produced more yellowing in resin composites with CQ and CQ-PPD. The use of PPD alone was not advantageous for producing good final properties when compared to CQ and CQ-PPD.

2007-04-01·Journal of Endourology3区 · 医学

Setting a New Standard for Topical Therapy of Upper-Tract Transitional-Cell Carcinoma: BCG and Interferon-α2B

3区 · 医学

Article

作者: Gupta, Mantu ; Katz, Mark H. ; Lee, Michael W.

BACKGROUND AND PURPOSEWe report our office-based technique and results of BCG and interferon-alpha2B (BCG-IFN) for upper-tract transitional-cell carcinoma (TCC).TECHNIQUEPapillary lesions were ablated endoscopically after biopsy. Office flexible cystoscopy was performed, and a 0.038-inch guidewire or Glidewire was advanced into the renal pelvis. A 5F ureteral catheter was placed over the wire, and a free flow of urine was confirmed. Half-strength BCG + 50 million units of IFN was infused under low pressure for 1 hour. The ureteral catheter was removed, and patients were instructed to void 1 hour later.RESULTSBetween 2000 and 2006, 10 patients with a median age of 72 years were treated with BCG-IFN for upper-tract TCC in 11 renal units. Follow-up ureteroscopy with or without biopsy was performed after a 6-week induction to evaluate response. Complete responders were placed on a maintenance regimen. With a median follow-up of 24 months, 8 patients (80%) demonstrated a complete response (CR) to therapy, and 2 had a partial response (decrease in tumor size, number, or both). Six patients with a CR have continued on maintenance therapy. There were no side effects or complications with the instillation therapy.CONCLUSIONWe describe a safe, minimally invasive, and effective office-based technique for upper-tract BCG-IFN instillation.

100 项与卡介菌纯蛋白衍生物（成都可恩生物科技）相关的药物交易

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