[Translation] Study on the pharmacokinetics and antibody generation of recombinant human interleukin-11 (I) for injection in patients with tumors after multiple consecutive administrations

通过山东阿华生物药业有限公司生产的注射用重组人白介素-11（百杰依）与齐鲁制药有限公司生产的注射用重组人白介素-11（巨和粒）在肿瘤患者中的连续多次给药药动学及抗体生成情况比较研究，为临床应用提供参考。

[Translation]

A comparative study on the pharmacokinetics and antibody production of recombinant human interleukin-11 for injection (Baijieyi) produced by Shandong Ahua Biopharmaceutical Co., Ltd. and recombinant human interleukin-11 for injection (Juheli) produced by Qilu Pharmaceutical Co., Ltd. in tumor patients after multiple continuous administration was conducted to provide a reference for clinical application.

Start Date18 Jul 2012

Sponsor / Collaborator

China Resources Angde Biotech Pharma Co., Ltd.

[+1]

CTR20132299 / Completed

注射用重组人白介素-11（Ⅰ）与市售白介素-11（巨和粒）药动学研究比较

[Translation] Comparison of the pharmacokinetic studies between recombinant human interleukin-11 (I) for injection and commercially available interleukin-11 (Juhe Granules)

研究山东阿华生物药业有限公司生产的注射用重组人白介素-11（Ⅰ）在中国健康志愿者中的单次给药药动学特征，并与市售白介素-11（巨和粒）的药动学特征进行比较。

[Translation]

To study the pharmacokinetic characteristics of single-dose recombinant human interleukin-11 (I) for injection produced by Shandong Ahua Biopharmaceutical Co., Ltd. in Chinese healthy volunteers and compare it with the pharmacokinetic characteristics of commercially available interleukin-11 (Juhe Granules).

Start Date21 May 2012

Sponsor / Collaborator

China Resources Angde Biotech Pharma Co., Ltd.

[+1]

CTR20131909 / RecruitingPhase 4

注射用重组人白介素-11（Ⅰ）与白介素-11治疗化疗致血小板减少有效和安全性随机双盲平行对照多中心临床研究

[Translation] A randomized, double-blind, parallel controlled, multicenter clinical study on the efficacy and safety of recombinant human interleukin-11 (I) for injection and interleukin-11 in the treatment of chemotherapy-induced thrombocytopenia

系统评价注射用重组人白介素-11（Ⅰ）与白介素-11治疗化疗所致血小板减少的有效性和安全性。

[Translation]

To systematically review the efficacy and safety of recombinant human interleukin-11 (I) for injection and interleukin-11 in the treatment of chemotherapy-induced thrombocytopenia.

Start Date24 Dec 2011

Sponsor / Collaborator

China Resources Angde Biotech Pharma Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant human interleukin-11(China Resources Angde Biotech)

100 Translational Medicine associated with Recombinant human interleukin-11(China Resources Angde Biotech)

100 Patents (Medical) associated with Recombinant human interleukin-11(China Resources Angde Biotech)

210

Literatures (Medical) associated with Recombinant human interleukin-11(China Resources Angde Biotech)

01 Mar 2024·Kidney International

Collectin 11 has a pivotal role in host defense against kidney and bladder infection in mice

Article

Author: Dong, Xia ; Han, Jin ; Zhou, Wuding ; Li, Ke ; Wu, Weiju ; Chen, Wan-Bing ; Cao, Bo ; Wu, Yi ; Zhao, Shujuan ; Yang, Jurong ; Min, Xiao-Yun ; Garred, Peter ; Wu, Kun-Yi ; Wang, Na ; Sacks, Steven H

The urinary tract is constantly exposed to microorganisms. Host defense mechanisms in protection from microbial colonization and development of urinary tract infections require better understanding to control kidney infection. Here we report that the lectin collectin 11 (CL-11), particularly kidney produced, has a pivotal role in host defense against uropathogen infection. CL-11 was found in mouse urine under normal and pathological conditions. Mice with global gene ablation of Colec11 had increased susceptibility to and severity of kidney and to an extent, bladder infection. Mice with kidney-specific Colec11 ablation exhibited a similar disease phenotype to that observed in global Colec11 deficient mice, indicating the importance of kidney produced CL-11 for protection against kidney and bladder infection. Conversely, intravesical or systemic administration of recombinant CL-11 reduced susceptibility to and severity of kidney and bladder infection. Mechanism analysis revealed that CL-11 can mediate several key innate defense mechanisms (agglutination, anti- adhesion, opsonophagocytosis), and limit local inflammatory responses to pathogens. Furthermore, CL-11-mediated innate defense mechanisms can act on clinically relevant microorganisms including multiple antibiotic resistant strains. CL-11 was detectable in eight of 24 urine samples from patients with urinary tract infections but not detectable in urine samples from ten healthy individuals. Thus, our findings demonstrate that CL-11 is a key factor of host defense mechanisms in kidney and bladder infection with therapeutic potential for human application.

01 Aug 2012·Supportive Care in CancerQ2 · MEDICINE

Multicenter, randomized study of genetically modified recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in cancer patients receiving chemotherapy

Q2 · MEDICINE

Article

Author: Yuee Teng ; Sunyoung Kim ; Yang Zhang ; Yun Dai ; Seong-Hyun Ho ; Jong-Mook Kim ; Seung Shin Yu ; Shikai Wu ; Liyan Xu ; Santai Song ; Shanshan Ma

PURPOSEThe aim of this study is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using original IL-11 as an active control, in a multicenter randomized trial involving 88 cancer patients undergoing chemotherapyMETHODSEighty-eight subjects who had platelets ≤ 75 × 10(9)/L during the prior chemotherapy were randomized to the MR or RM group. Cohort MR consists of subcutaneous injection of mIL-11 (7.5 μg/kg/day) for 10 days, beginning 72 h after chemotherapy for a 21-day chemotherapy cycle (cycle-1) followed by that of recombinant human interleukin-11 (rhIL-11) (25 μg/kg/day) for another 10 days (cycle-2). Cohort RM represents the reverse sequence. Intent-to-treat populations of mIL-11 (n = 73) or rhIL-11 (n = 80) were analyzed to evaluate the safety.RESULTSThe incidence of drug-related adverse events of mIL-11 (32.9%) was lower than that of rhIL-11 (51.3%) (p = 0.033). There were no unexpected ≥ grade-3 adverse events, and no subject developed antibodies to the mIL-11 protein. Sixty-two subjects were analyzed for efficacy by measuring average platelet levels. Both mIL-11 and rhIL-11 increased nadir platelet levels (62.6 ± 34.9 × 10(9)/L for mIL-11 vs. 60.2 ± 31.7 × 10(9)/L for rhIL-11) as compared with the untreated control group (41.2 ± 17.7 × 10(9)/L) (p < 0.0001). There was no statistical difference in average platelet levels and platelet recovery rate between mIL-11 and rhIL-11.CONCLUSIONSThis study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT.

01 Feb 2011·Biochemical and Biophysical Research CommunicationsQ3 · BIOLOGY

Improvement of biological and pharmacokinetic features of human interleukin-11 by site-directed mutagenesis

Q3 · BIOLOGY

Article

Author: Haesook Ahn ; Suyong Ma ; Yu Ri Hwang ; Dong-Sik Kim ; Jong-Mook Kim ; Yuni Jung ; Seong-Hyun Ho ; Sunyoung Kim ; Sujeong Kim

Recombinant human interleukin-11 (rhIL-11) has been shown to increase platelet counts in animals and humans and is the only drug approved for its use in chemotherapy-induced thrombocytopenia (CIT). However, due to its serious side effects, its clinical use has been limited. The current work presents significantly improved efficacy of rhIL-11 via knowledge based re-designing process. The interleukin-11 mutein (mIL-11) was found to endure chemical and proteolytic stresses, while retaining the biological activity of rhIL-11. The improved efficacy of mIL-11 was evident after subcutaneous administration of mIL-11 and rhIL-11 in the rodent and primate models. More than three-fold increase in maximum plasma concentration (Cmax) and area-under-the curve (AUC) was observed. Furthermore, three-fold higher increase in the platelet counts was obtained after seven consecutive daily subcutaneous mIL-11 injections than that with rhIL-11. The mIL-11 demonstrated not only improved stability but also enhanced efficacy over the currently used rhIL-11 regimen, thereby suggesting less toxicity.

100 Deals associated with Recombinant human interleukin-11(China Resources Angde Biotech)

External Link

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Thrombocytopenia	CN	China Resources Angde Biotech Pharma Co., Ltd.	18 Apr 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2004	Not Applicable	Pancytopenia	-	Low-dose recombinant IL-11	(txkovuxltw) = yldpgtorxh eaavkjvika (bwlzrjwhnp ) View more	-	15 Jul 2004

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