重组人乳铁蛋白溶菌酶 (武汉禾元生物)(Recombinant human lactoferrin lysozyme(Wuhan Healthgen Biotechnology Co. Ltd.))

概要

基本信息

药物类型

酶

别名-

靶点-

作用机制-

治疗领域

感染消化系统疾病其他疾病

在研适应症

急性腹泻痢疾轮状病毒感染

非在研适应症-

原研机构

武汉禾元生物科技股份有限公司

在研机构

武汉禾元生物科技股份有限公司

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

3

项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的临床试验

CTR20212251 / Completed临床2期

一项评价重组人乳铁蛋白溶菌酶口服液治疗轮状病毒感染导致儿童急性腹泻的有效性和安全性的多中心、随机、双盲、安慰剂对照II期临床研究

在有急性腹泻症状（≧3次/24小时内）就医，粪便病毒学检测轮状病毒阳性的儿童患者中小样本验证重组人乳铁蛋白溶菌酶口服液连续5天治疗的临床疗效。预计在14天的观察中，治疗组发生中、重度疾病情况（Vesikari Clinical Severity Scoring System≧7，VSS）的受试者比例少于安慰剂组，并且预计不伴有不良反应的明显增加。探索两个治疗组（高剂量组和低剂量组）是否显示有疗效差异的趋势。

开始日期2022-01-12

申办/合作机构

武汉禾元生物科技股份有限公司

CTR20201773 / Completed临床1期

在中国健康成年受试者中评估重组人乳铁蛋白溶菌酶口服液单次给药、多次给药的安全性、耐受性的I期临床研究

主要研究目的：评价重组人乳铁蛋白溶菌酶口服液在中国健康成年受试者中单次、多次给药后的安全性和耐受性。次要研究目的：为重组人乳铁蛋白溶菌酶口服液的后续临床试验给药剂量和给药方案的探索提供科学依据。

开始日期2020-09-08

申办/合作机构

武汉禾元生物科技股份有限公司

NCT00095186 / Completed临床2期

A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients With Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for RCC

The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients who have failed at least one prior systemic therapy for RCC.

开始日期2004-09-01

申办/合作机构

Agennix AG

100 项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的临床结果

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100 项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的转化医学

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100 项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的专利（医药）

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123

项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的文献（医药）

2024-08-01·Food and Chemical Toxicology

Workshop report: A study roadmap to evaluate the safety of recombinant human lactoferrin expressed in Komagataella phaffii intended as an ingredient in conventional foods – Recommendations of a scientific expert panel

Article

作者: Merker, Robert ; Conze, Dietrich ; Clark, Anthony ; Lukacs, Nicholas W ; Kaminski, Norbert ; Kruger, Claire ; DiNovi, Michael ; Peterson, Ross ; Malinczak, Carrie-Anne ; Burns Naas, Leigh Ann ; Lönnerdal, Bo

Human milk lactoferrin (hmLF) is a glycoprotein with well-known effects on immune function. Helaina Inc. has used a glycoengineered yeast, Komatagaella phaffii, to produce recombinant human lactoferrin (Helaina rhLF, Effera™) that is structurally similar to hmLF with intended uses as a food ingredient. However, earlier FDA reviews of rhLF were withdrawn due to insufficient safety data and unanswered safety questions the experts and FDA raised about the immunogenicity/immunotoxicity risks of orally ingested rhLF. Helaina organized a panel of leading scientists to build and vet a safety study roadmap containing the studies and safety endpoints needed to address these questions. Panelists participated in a one-day virtual workshop in June 2023 and ensuing discussions through July 2023. Relevant workshop topics included physicochemical properties of LF, regulatory history of bovine LF and rhLF as food ingredients in the FDA's generally recognized as safe (GRAS) program, and synopses of publicly available studies on the immunogenicity/alloimmunization, immunotoxicology, iron homeostasis, and absorption, distribution, metabolism, and excretion of rhLF. Panelists concluded that the safety study roadmap addresses the unanswered safety questions and the intended safe use of rhLF as a food ingredient for adults and agreed on broad applications of the roadmap to assess the safety and support GRAS of other recombinant milk proteins with immunomodulatory functions.

2024-08-01·International Journal of Toxicology

Dose Range-Finding Toxicity Study in Rats With Recombinant Human Lactoferrin Produced in Komagataella phaffii

Article

作者: Crawford, Robert B. ; Kaminski, Norbert E. ; Clark, Anthony J. ; Blevins, Lance K. ; Ferraro, Bryce ; Sass, June S. ; Vishwanath-Deutsch, Roma ; Malinczak, Carrie-Anne ; Peterson, Ross

The oral toxicity of recombinant human lactoferrin (rhLF, Helaina rhLF, Effera™) produced in Komagataella phaffii was investigated in adult Sprague Dawley rats by once daily oral gavage for 14 consecutive days. The study used groups of 3–6 rats/sex/dose. The vehicle control group received sodium citrate buffer, and the test groups received daily doses of 200, 1000, and 2000 mg of rhLF in sodium citrate buffer per kg body weight. Bovine LF at 2000 mg/kg body weight per day was used as a comparative control. Clinical observations, body weight, hematology, clinical chemistry, iron parameters, immunophenotyping, and gross examination at necropsy were used as criteria for detecting the effects of treatment in all groups and to help select dose levels for future toxicology studies. Quantitative LF levels were also analyzed as an indication of bioavailability. Overall, administration of Helaina rhLF by once daily oral gavage for 14 days was well tolerated in rats at levels up to 2000 mg/kg/day, or 57 × Helaina’s intended commercial use in adults, and indicating that a high dose of 2000 mg/kg/day is appropriate for future definitive toxicology studies.

2024-07-01·Food and Chemical Toxicology

A review of the safety evidence on recombinant human lactoferrin for use as a food ingredient

Review

作者: Malinczak, Carrie-Anne ; Katz, Laura ; Clark, Anthony J ; Conze, Dietrich ; Dallas, David C ; Peterson, Ross ; Vishwanath-Deutsch, Roma ; Kruger, Claire ; Besada-Lombana, Pamela

Published studies on the glycosylation, absorption, distribution, metabolism, excretion, and safety outcomes of orally ingested recombinant human lactoferrin (rhLF) were reviewed in the context of unanswered safety questions, including alloimmunization, allergenicity, and immunotoxicity potential of rhLF during repeated exposure. The primary objective was to summarize current safety data of rhLF produced in transgenic host expression systems. Overall, results from animal and human studies showed that rhLF was well tolerated and safe. Animal data showed no significant toxicity-related outcomes among any safety or tolerability endpoints. The no observed adverse effect levels (NOAEL) were at the highest level tested in both iron-desaturated and -saturated forms of rhLF. Although one study reported outcomes of rhLF on immune parameters, no animal studies directly assessed immunogenicity or immunotoxicity from a safety perspective. Data from human studies were primarily reported as adverse events (AE). They showed no or fewer rhLF-related AE compared to control and no evidence of toxicity, dose-limiting toxicities, or changes in iron status in various subpopulations. However, no human studies evaluated the immunomodulatory potential of rhLF as a measure of safety. Following this review, a roadmap outlining preclinical and clinical studies with relevant safety endpoints was developed to address the unanswered safety questions.

100 项与重组人乳铁蛋白溶菌酶 (武汉禾元生物) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性腹泻	临床2期	中国	武汉禾元生物科技股份有限公司	2022-01-12
痢疾	临床2期	中国	武汉禾元生物科技股份有限公司	2022-01-12
轮状病毒感染	临床2期	中国	武汉禾元生物科技股份有限公司	2022-01-12