Treatment of Sepsis with Talactoferrin

用 Talactoferrin 治疗脓毒症

• 批准号: 7681601
• 负责人: KAREL PETRAK
• 金额: $ 82.06万
• 依托单位: AGENNIX, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-10 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7681601
• 关键词: Adverse event; Animal Model; Anti-Inflammatory Agents; Attenuated; Biological Markers; C-reactive protein; Cause of Death; Clinical; Clinical Research; Clinical Trials; Coronary Care Units; Data; Development; Disease; Double-Blind Method; Drug usage; Enrollment; Evaluation; Feces; Financial Support; Functional disorder; Generations; Human; Incidence; Intensive Care Units; Interleukin-10; Interleukin-6; Iron; Laboratories; Lactoferrin; Literature; Malignant Neoplasms; Medical; Monitor; Morbidity - disease rate; Oral; Organ failure; Patients; Performance; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Phase; Phase III Clinical Trials; Placebos; Process; Publishing; Randomized; Recombinants; Route; Safety; Sepsis; Series; Serious Adverse Event; Serum; Severities; Shock; Staging; United States; Ventilator; base; clinical efficacy; cost; cytokine; efficacy trial; experience; mortality; patient population; pre-clinical; procalcitonin; protective effect; research study; standard of care

DESCRIPTION (provided by applicant): Severe sepsis is a major cause of morbidity and mortality throughout the world. It is the leading cause of death in non-coronary intensive care units (ICUs) in the United States, with more than 750,000 cases occurring every year. This means that in the United States, more than 500 patients die from severe sepsis every day, with 28% to 50% of the patients succumbing to the disease process at an average cost of $22,000 per patient. Successful development of TLF-based therapy for sepsis would satisfy a significant unmet medical need. Agennix has now established a manufacture of a pharmaceutical-grade talactoferrin, it has demonstrated its safety in clinical studies for various indications, and is now interacting with the FDA to obtain a go-ahead to initiate clinical Phase 3 studies in cancer. The development of talactoferrin is therefore at a stage that a demonstration of its clinical efficacy in sepsis would put the generation of a product to treat sepsis on a relatively easy and straightforward path.

描述（由申请人提供）：严重脓毒症是全世界发病率和死亡率的主要原因。它是美国非冠状动脉重症监护病房（icu）死亡的主要原因，每年发生超过75万例。这意味着，在美国，每天有500多名患者死于严重败血症，其中28%至50%的患者死于疾病过程，平均每位患者的成本为2.2万美元。基于tlf的败血症治疗的成功发展将满足一个重要的未满足的医疗需求。Agennix现在已经建立了制药级talactoferrin的生产，它已经在各种适应症的临床研究中证明了它的安全性，现在正在与FDA进行互动，以获得启动癌症临床3期研究的批准。因此，talactoferrin的开发处于一个阶段，证明其在败血症中的临床疗效将使生产治疗败血症的产品走上一条相对容易和直接的道路。

项目成果

A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis.

一项关于塔乳铁蛋白在严重脓毒症患者中的安全性和有效性的 2 期随机、双盲、安慰剂对照研究。

• DOI: 10.1097/ccm.0b013e3182741551
• 发表时间: 2013
• 期刊: Critical care medicine
• 影响因子: 8.8
• 作者: Guntupalli,Kalpalatha;Dean,Nathan;Morris,PeterE;Bandi,Venkata;Margolis,Benjamin;Rivers,Emanuel;Levy,Mitchell;Lodato,RobertF;Ismail,PreetiM;Reese,Amber;Schaumberg,JohnP;Malik,Rajesh;Dellinger,RPhillip;TLFLF-0801Investigator
• 通讯作者: TLFLF-0801Investigator